Lymphoma, Non-Hodgkin
Conditions
Keywords
Non-Hodgkin lymphoma, Aggressive B-cell non-Hodgkin lymphoma, Diffuse large B-cell lymphoma, Relapse / refractory lymphoma, Transplant not eligible, High-grade B-cell lymphoma, Primary central nervous system lymphoma, Transformed follicular lymphoma, Follicular lymphoma Grade 3B, JCAR017, Liso-Cel
Brief summary
The purpose of this study is to evaluate the efficacy and safety of JCAR017 in participants with aggressive B-cell non-Hodgkin lymphoma (B-NHL)
Detailed description
This is a study to determine the efficacy and safety of JCAR017 in adult participants with aggressive B-cell NHL. The study will enroll participants in Europe and Japan with diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS; de novo or transformed follicular lymphoma \[tFL\]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (HGBL), follicular lymphoma Grade 3B (FL3B), and primary central nervous system lymphoma (PCNSL). Participants with secondary central nervous system (CNS) involvement are allowed. Once enrolled, participants will undergo leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, participants will receive lymphodepleting chemotherapy followed by infusion of JCAR017. JCAR017 will be administered by intravenous infusion. Participants will be followed for approximately 2 years after their JCAR017 infusion for safety, disease status, survival and health-related quality of life. Delayed adverse events following exposure to gene modified T cells will be assessed and long-term persistence of these modified T cells will continue to be monitored under a separate long-term follow-up protocol for up to 15 years after JCAR017 infusion as per competent authority guidelines.
Interventions
DRUGJCAR017
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological confirmation of diagnosis at last relapse * Adequate organ function * Adequate vascular access for leukapheresis procedure
Exclusion criteria
* Prior history of malignancies, other than aggressive relapsed/refractory Non-Hodgkin Lymphoma, unless the participant has been in remission for ≥ 2 years with the exception of non-invasive malignancies * Received previous CD19-targeted therapy * Progressive vascular tumor invasion, thrombosis, or embolism Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3 | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) | Overall response rate (ORR) by Independent Review Committee (Cohorts 1, 2, 3). ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: No * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: No * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: No * Organ enlargement: Spleen length decreased \> 50% * New lesions: No |
| Overall Response Rate (ORR) Per Investigator in Cohort 4 | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) | Overall response rate (ORR) is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: None * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: None/normal * Organ enlargement: Spleen length decreased \> 50% * New lesions: No |
| Overall Response Rate (ORR) Per Investigator in Cohort 5 | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) | Overall response rate (ORR) determined by Investigator assessment after JCAR017 infusion. The ORR is the percent of participants with best overall response (BOR) of either complete response (CR), complete response unconfirmed (Cru) or partial response (PR). Complete response (CR): * Brain imaging: No contrast enhancement * Corticosteroid dose: None * Eye examination: Normal * Cerebrospinal fluid cytology: Negative Complete response unconfirmed (CRu): * Brain imaging: No contrast enhancement, Minimal abnormality * Corticosteroid dose: Any * Eye examination: Normal, minor RPE abnormality * Cerebrospinal fluid cytology: Negative Partial response (PR): * Brain imaging: 50% decrease in enhancing tumor, no contrast enhancement. * Corticosteroid dose: Irrelevant * Eye examination: Minor RPE abnormality, decrease in vitreous cells or retinal infiltrate. * Cerebrospinal fluid cytology: Negative, persistent or suspicious |
| Number of Participants With Adverse Events in Cohort 7 | From leukapheresis to end of study (up to approximately 63 months) | An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death. |
| Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 | From leukapheresis to end of study (up to approximately 63 months) | A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death. |
| Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 | At Baseline and Day 29 after JCAR017 infusion | JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death). |
| Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 | At Baseline and Day 29 after JCAR017 infusion | JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria | From JCAR017 infusion to progressive disease or death due to any reason, whichever occurred first (up to approximately 63 months) | Progression-free survival is defined as the interval from the date of JCAR017 infusion to progressive disease or death due to any cause, whichever occurred first. Per European Medicines Agency (EMA) criteria, participants who did not experience progressive disease and who did not die before the data cutoff date were censored at the time of the last visit with adequate response assessment when the participants were known not to have progressed. Estimated using Kaplan-Meier product-limit estimates. |
| Overall Survival (OS) | From the date of JCAR017 infusion to the date of death due to any reason (up to approximately 63 months). | Overall survival is defined as the interval from the date of JCAR017 infusion to the date of death due to any reason. Data from surviving participants was censored at the last time that the participant was known to be alive. Estimated using Kaplan-Meier product-limit estimates. |
| Duration of Response (DOR) | From JCAR017 infusion until disease progression, death due to any reason, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) | DOR is from first response (complete response (CR), CR unconfirmed (CRu) or partial response (PR)) to progression (PD) or death. Those without PD or death were censored at the last assessment. CR via PET-CT: Lymph/extralymph: Score 1/2/3a w/w-out resid mass, no new lesions, No FDG-avid disease in bone marrow (BM) CR via CT scan: Lymph/extralymph: Target/nodal ≤ 1.5 cm, no new lesions, normal BM CR Cohort 5: No contrast enhance, no corticosteroid, normal eye exam, neg CSF cytology CRu Cohort 5: No contrast enhance, min abnorm, normal eye exam, neg CSF cytology PR via PET-CT: Lymph/extralymph: Score 4/5b, red uptake, no new lesions, resid uptake incr, reduced in BM PR via CT scan: Lymph/extralymph: 50% decr in sum of diam ≤ 6 target/extranodal, no new/nonmeasured lesions, Organ enlarge: Spleen decr \> 50% PR Cohort 5: 50% decr in enhancing tumor, no contrast enhance, Eye exam: Minor abnorm, decr in vitreous cells/retinal infiltrate, negative, persist or suspic CSF cytology. |
| Maximum Concentration (Cmax) of JCAR017 by qPCR | At baseline and up until 24 months post JCAR017 infusion | Cmax is the maximum or peak concentration of drug reached in the plasma following a dose of the drug. Quantitative polymerase chain reaction (qPCR) was used to determine Cmax by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion. |
| Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | From leukapheresis to end of study (up to approximately 63 months) | An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death. |
| Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR | At baseline and up until 24 months post JCAR017 infusion | Area Under the Curve (AUC) represents the total exposure of participants to study drug. Quantitative polymerase chain reaction (qPCR) was used to determine AUC by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion. |
| Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | At Day 29 and Months 2, 3, 6, 9, 12, 18, and 24 post JCAR017 infusion. | Persistence is defined as a transgene count greater than or equal to the lower limit of detection (LLOD) of 5 copies per reaction. Data obtained after the start of a new anti-cancer therapy were excluded. qPCR = Quantitative polymerase chain reaction. |
| Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion. | The EORTC QLQ-C30 consists of five functional scales (physical, role, emotional, cognitive, social), three symptom scales (fatigue, nausea/vomiting, pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The questionnaire is scored on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. The raw score is the average of the items contributing to the scale. The final scores are calculated via linear transformation of raw scores and range from 0 to 100. For functional scales higher scores indicate better QoL. For symptom scales and single items lower scores indicate fewer symptoms, i.e. better QoL. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion. Only global health, fatigue, physical and cognitive functioning subscales were assessed. |
| Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion. | The Functional Assessment of Cancer Treatment-Lymphoma Additional concerns subscale (FACT-LymS) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. Only the LYM subscale was administered in this study. The LYM items are scored on a 0 (Not at all) to 4 (Very much) response scale. Items are aggregated to a single score on a 0-60 scale. Lower scores indicate better health outcomes. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion. |
| Time to Peak Concentration (Tmax) of JCAR017 by qPCR | At baseline and up until 24 months post JCAR017 infusion | Time to maximum concentration (Tmax) is the time it takes for a drug to reach the maximum concentration (Cmax) after administration. Quantitative polymerase chain reaction (qPCR) was used to determine Tmax by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion. |
| Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | At Baseline and Day 29 after JCAR017 infusion | JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death. |
| Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | From leukapheresis to end of study (up to approximately 63 months) | A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death. |
| Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | At Baseline and Day 29 after JCAR017 infusion | JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death. |
| Overall Response Rate (ORR) in Cohort 7 | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) | ORR by Independent Review Committee. ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: None * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: None/normal * Organ enlargement: Spleen length decreased \> 50% * New lesions: No |
| Complete Response Rate (CRR) | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) | Complete response rate is defined as percentage of participants achieving a best overall response of complete response. Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: None * New lesions: No * Bone marrow: Normal Complete response (CR) (Cohort 5): * Brain imaging: No contrast enhancement * Corticosteroid dose: None * Eye examination: Normal * Cerebrospinal fluid cytology: Negative Complete response unconfirmed (CRu) (Cohort 5): * Brain imaging: No contrast enhancement, Minimal abnormality * Corticosteroid dose: Any * Eye examination: Normal, minor RPE abnormality * Cerebrospinal fluid cytology: Negative |
| Event Free Survival (EFS) | From JCAR017 infusion to death due to any reason, progressive disease, or starting a new anticancer therapy (up to approximately 63 months). | Event-free survival is from JCAR017 infusion to death from any cause, progressive disease, or starting a new anticancer therapy. If a participant did not have an EFS event prior to data cutoff, EFS was censored at last disease assessment. Progressive disease (PD): * Target nodes/nodal masses: PPD progression. * Extranodal lesion: LDi \> 1.5 cm and increase by ≥ 50% from PPD nadir. * Splenomegaly: \> 50% of prior increase from baseline or by at least 2 cm from baseline. * Nonmeasured lesions: New or clear progression. * New lesions: Regrowth of previously resolved lesions. * Bone marrow: New or recurrent Progressive Disease (Cohort 5): * Brain imaging: \> 25% increase in enhancing lesion from baseline or best response. * Eye Exam: Increased vitreous cell counts or progressive retinal or optic nerve infiltration. * New lesion or site of disease |
Countries
Austria, Belgium, Finland, France, Germany, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom
Participant flow
Pre-assignment details
During the pretreatment period participants underwent leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, participants entered the treatment period and received lymphodepleting chemotherapy followed by infusion of JCAR017. Cohort 6 was planned but subsequently removed from the study. No participants were enrolled into Cohort 6.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). | 45 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). | 32 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). | 14 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). | 4 |
| Cohort 5: Primary Central Nervous System Lymphoma JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). | 7 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). | 11 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Treatment Period | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period | Death | 3 | 1 | 0 | 0 | 0 | 0 |
| Treatment Period | Participant Withdrew from Study | 0 | 1 | 0 | 0 | 0 | 0 |
| Treatment Period | Physician Decision | 0 | 1 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Cohort 5: Primary Central Nervous System Lymphoma | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 60.2 Years STANDARD_DEVIATION 10.6 | 73.3 Years STANDARD_DEVIATION 5.5 | 57.6 Years STANDARD_DEVIATION 10.08 | 63.5 Years STANDARD_DEVIATION 21.11 | 57.0 Years STANDARD_DEVIATION 5.74 | 58.1 Years STANDARD_DEVIATION 12.47 | 63.3 Years STANDARD_DEVIATION 11.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 22 Participants | 14 Participants | 2 Participants | 5 Participants | 7 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 9 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 14 Participants | 0 Participants | 0 Participants | 0 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 10 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants | 25 Participants |
| Race (NIH/OMB) White | 37 Participants | 19 Participants | 0 Participants | 3 Participants | 5 Participants | 7 Participants | 71 Participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 6 Participants | 1 Participants | 3 Participants | 4 Participants | 42 Participants |
| Sex: Female, Male Male | 30 Participants | 19 Participants | 8 Participants | 3 Participants | 4 Participants | 7 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 32 / 45 | 22 / 32 | 9 / 14 | 0 / 4 | 5 / 7 | 4 / 11 |
| other Total, other adverse events | 40 / 45 | 25 / 32 | 12 / 14 | 1 / 4 | 5 / 7 | 9 / 11 |
| serious Total, serious adverse events | 19 / 45 | 8 / 32 | 2 / 14 | 0 / 4 | 2 / 7 | 1 / 11 |
Outcome results
Primary
Number of Participants With Adverse Events in Cohort 7
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Time frame: From leukapheresis to end of study (up to approximately 63 months)
Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Adverse Events in Cohort 7 | AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC) | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Adverse Events in Cohort 7 | AEs occurring between LDC and JCAR017 infusion | 2 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Adverse Events in Cohort 7 | AEs occurring between JCAR017 infusion and Day 30 | 9 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Adverse Events in Cohort 7 | AEs occurring between Day 31 and Day 90 | 7 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Adverse Events in Cohort 7 | AEs occurring between Day 91 and end of study | 7 Participants |
Primary
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).
Time frame: At Baseline and Day 29 after JCAR017 infusion
Population: All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohort 7 only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 | Leukocytes (10^9/L) - Day 29 | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 | Neutrophils, Segmented (10^9/L) - Day 29 | 2 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 | Platelets (10^9/L) - Day 29 | 5 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 | Activated Partial Thromboplastin Time (sec) - Day 29 | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 | Prothrombin Intl. Normalized Ratio - Day 29 | 1 Participants |
Primary
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).
Time frame: At Baseline and Day 29 after JCAR017 infusion
Population: All participants in the JCAR017 treated set with available baseline and Day 29 serum chemistry results. Prespecified to be reported for cohort 7 only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 | Albumin (g/L) - Day 29 | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 | Phosphate (mmol/L) - Day 29 | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 | Alkaline Phosphatase (U/L) - Day 29 | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 | Alanine Aminotransferase (U/L) - Day 29 | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 | Aspartate Aminotransferase (U/L) - Day 29 | 1 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 | Bilirubin (umol/L) - Day 29 | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 | Creatinine (umol/L) - Day 29 | 7 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 | Triglycerides (mmol/L) - Day 29 | 3 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 | Urate (umol/L) - Day 29 | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) in Cohort 7
A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Time frame: From leukapheresis to end of study (up to approximately 63 months)
Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 | SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC) | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 | SAEs occurring between LDC and JCAR017 infusion | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 | SAEs occurring between JCAR017 infusion and Day 30 | 1 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 | SAEs occurring between Day 31 and Day 90 | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 | SAEs occurring between Day 91 and end of study | 1 Participants |
Primary
Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3
Overall response rate (ORR) by Independent Review Committee (Cohorts 1, 2, 3). ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: No * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: No * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: No * Organ enlargement: Spleen length decreased \> 50% * New lesions: No
Time frame: From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)
Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1,2, and 3 only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3 | 61.1 Percent of Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3 | 63.0 Percent of Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3 | 70.0 Percent of Participants |
Primary
Overall Response Rate (ORR) Per Investigator in Cohort 4
Overall response rate (ORR) is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: None * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: None/normal * Organ enlargement: Spleen length decreased \> 50% * New lesions: No
Time frame: From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)
Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohort 4 only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Overall Response Rate (ORR) Per Investigator in Cohort 4 | 100 Percent of Participants |
Primary
Overall Response Rate (ORR) Per Investigator in Cohort 5
Overall response rate (ORR) determined by Investigator assessment after JCAR017 infusion. The ORR is the percent of participants with best overall response (BOR) of either complete response (CR), complete response unconfirmed (Cru) or partial response (PR). Complete response (CR): * Brain imaging: No contrast enhancement * Corticosteroid dose: None * Eye examination: Normal * Cerebrospinal fluid cytology: Negative Complete response unconfirmed (CRu): * Brain imaging: No contrast enhancement, Minimal abnormality * Corticosteroid dose: Any * Eye examination: Normal, minor RPE abnormality * Cerebrospinal fluid cytology: Negative Partial response (PR): * Brain imaging: 50% decrease in enhancing tumor, no contrast enhancement. * Corticosteroid dose: Irrelevant * Eye examination: Minor RPE abnormality, decrease in vitreous cells or retinal infiltrate. * Cerebrospinal fluid cytology: Negative, persistent or suspicious
Time frame: From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)
Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohort 5 only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Overall Response Rate (ORR) Per Investigator in Cohort 5 | 80.0 Percent of Participants |
Secondary
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
The EORTC QLQ-C30 consists of five functional scales (physical, role, emotional, cognitive, social), three symptom scales (fatigue, nausea/vomiting, pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The questionnaire is scored on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. The raw score is the average of the items contributing to the scale. The final scores are calculated via linear transformation of raw scores and range from 0 to 100. For functional scales higher scores indicate better QoL. For symptom scales and single items lower scores indicate fewer symptoms, i.e. better QoL. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion. Only global health, fatigue, physical and cognitive functioning subscales were assessed.
Time frame: At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion.
Population: All participants in the JCAR017-treated set with completed baseline questionnaires and with at least one completed post-baseline questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 365 | -6.67 Scores on a Scale | Standard Deviation 20.337 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 60 | 2.78 Scores on a Scale | Standard Deviation 12.444 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 29 | 3.03 Scores on a Scale | Standard Deviation 24.418 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 1 | -3.43 Scores on a Scale | Standard Deviation 17.301 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 60 | 5.00 Scores on a Scale | Standard Deviation 14.778 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 545 | 4.94 Scores on a Scale | Standard Deviation 25.526 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 545 | -6.48 Scores on a Scale | Standard Deviation 18.53 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 545 | -3.70 Scores on a Scale | Standard Deviation 26.69 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 60 | 3.11 Scores on a Scale | Standard Deviation 15.135 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 60 | -9.63 Scores on a Scale | Standard Deviation 18.623 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 180 | -8.33 Scores on a Scale | Standard Deviation 21.254 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 29 | -2.63 Scores on a Scale | Standard Deviation 18.555 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 730 | -11.11 Scores on a Scale | Standard Deviation 12.975 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 365 | 0.67 Scores on a Scale | Standard Deviation 16.163 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 730 | 0.93 Scores on a Scale | Standard Deviation 22.947 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 1 | -3.33 Scores on a Scale | Standard Deviation 20.97 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 365 | -11.67 Scores on a Scale | Standard Deviation 22.292 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 90 | -4.53 Scores on a Scale | Standard Deviation 19.795 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 90 | 0.00 Scores on a Scale | Standard Deviation 13.074 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 29 | -2.53 Scores on a Scale | Standard Deviation 16.203 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 730 | -1.39 Scores on a Scale | Standard Deviation 18.06 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 270 | 3.33 Scores on a Scale | Standard Deviation 10.05 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 180 | -2.78 Scores on a Scale | Standard Deviation 15.624 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 90 | 2.47 Scores on a Scale | Standard Deviation 14.766 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 180 | 6.94 Scores on a Scale | Standard Deviation 13.685 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 730 | 1.11 Scores on a Scale | Standard Deviation 15.785 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 1 | 1.63 Scores on a Scale | Standard Deviation 26.959 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 545 | -7.41 Scores on a Scale | Standard Deviation 18.84 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 365 | -3.33 Scores on a Scale | Standard Deviation 14.861 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 180 | 7.78 Scores on a Scale | Standard Deviation 12.975 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 270 | 6.25 Scores on a Scale | Standard Deviation 20.14 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 270 | 0.00 Scores on a Scale | Standard Deviation 22.473 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 90 | 3.46 Scores on a Scale | Standard Deviation 16.781 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 29 | -1.26 Scores on a Scale | Standard Deviation 14.301 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 1 | -4.41 Scores on a Scale | Standard Deviation 17.07 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 270 | -9.26 Scores on a Scale | Standard Deviation 15.594 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 60 | 0.98 Scores on a Scale | Standard Deviation 10.978 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 1 | -3.62 Scores on a Scale | Standard Deviation 17.376 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 90 | 1.28 Scores on a Scale | Standard Deviation 22.527 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 270 | 0.00 Scores on a Scale | Standard Deviation 0 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 29 | 3.51 Scores on a Scale | Standard Deviation 14.25 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 180 | -2.08 Scores on a Scale | Standard Deviation 5.893 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 90 | -1.28 Scores on a Scale | Standard Deviation 12.659 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 365 | -4.76 Scores on a Scale | Standard Deviation 20.141 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 180 | 1.04 Scores on a Scale | Standard Deviation 23.332 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 730 | 3.70 Scores on a Scale | Standard Deviation 9.072 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 270 | 9.72 Scores on a Scale | Standard Deviation 9.742 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 270 | 0.00 Scores on a Scale | Standard Deviation 22.222 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 365 | 3.57 Scores on a Scale | Standard Deviation 11.664 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 29 | 0.00 Scores on a Scale | Standard Deviation 18.002 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 180 | 2.78 Scores on a Scale | Standard Deviation 34.503 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 545 | 3.57 Scores on a Scale | Standard Deviation 26.726 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 730 | -4.17 Scores on a Scale | Standard Deviation 12.638 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 90 | -4.27 Scores on a Scale | Standard Deviation 17.881 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 1 | -6.09 Scores on a Scale | Standard Deviation 21.074 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 60 | -1.31 Scores on a Scale | Standard Deviation 20.743 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 29 | -4.21 Scores on a Scale | Standard Deviation 10.706 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 60 | -0.39 Scores on a Scale | Standard Deviation 21.275 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 29 | 2.34 Scores on a Scale | Standard Deviation 12.046 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 90 | 3.59 Scores on a Scale | Standard Deviation 12.054 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 60 | 7.84 Scores on a Scale | Standard Deviation 17.547 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 1 | 1.45 Scores on a Scale | Standard Deviation 16.173 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 180 | -8.33 Scores on a Scale | Standard Deviation 31.219 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 270 | 1.11 Scores on a Scale | Standard Deviation 19.052 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 1 | -5.07 Scores on a Scale | Standard Deviation 17.898 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 730 | -5.56 Scores on a Scale | Standard Deviation 8.607 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 365 | 0.95 Scores on a Scale | Standard Deviation 16.069 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 545 | -1.59 Scores on a Scale | Standard Deviation 19.698 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 545 | 2.38 Scores on a Scale | Standard Deviation 11.501 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 545 | -1.90 Scores on a Scale | Standard Deviation 19.135 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 730 | -8.89 Scores on a Scale | Standard Deviation 28.493 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 365 | 0.00 Scores on a Scale | Standard Deviation 0 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 270 | -3.33 Scores on a Scale | Standard Deviation 26.745 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 730 | -3.33 Scores on a Scale | Standard Deviation 8.607 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 90 | -5.71 Scores on a Scale | Standard Deviation 11.174 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 730 | 5.56 Scores on a Scale | Standard Deviation 14.344 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 1 | 3.33 Scores on a Scale | Standard Deviation 20.32 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 270 | 3.33 Scores on a Scale | Standard Deviation 13.944 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 270 | -6.67 Scores on a Scale | Standard Deviation 14.907 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 545 | -13.33 Scores on a Scale | Standard Deviation 23.094 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 180 | -5.71 Scores on a Scale | Standard Deviation 19.024 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 60 | 4.17 Scores on a Scale | Standard Deviation 16.457 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 180 | -13.10 Scores on a Scale | Standard Deviation 35.635 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 730 | -4.17 Scores on a Scale | Standard Deviation 15.957 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 365 | 13.89 Scores on a Scale | Standard Deviation 33.179 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 60 | 0.00 Scores on a Scale | Standard Deviation 27.889 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 270 | -2.67 Scores on a Scale | Standard Deviation 22.41 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 90 | -5.95 Scores on a Scale | Standard Deviation 17.817 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 365 | -4.17 Scores on a Scale | Standard Deviation 8.333 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 90 | 4.76 Scores on a Scale | Standard Deviation 20.893 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 1 | -6.67 Scores on a Scale | Standard Deviation 10.244 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 180 | 11.90 Scores on a Scale | Standard Deviation 20.893 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 1 | -3.33 Scores on a Scale | Standard Deviation 11.44 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 730 | -6.25 Scores on a Scale | Standard Deviation 7.979 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 60 | 3.70 Scores on a Scale | Standard Deviation 31.946 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 29 | 3.33 Scores on a Scale | Standard Deviation 13.147 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 90 | 4.76 Scores on a Scale | Standard Deviation 35.635 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 365 | -16.67 Scores on a Scale | Standard Deviation 20 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 29 | -10.00 Scores on a Scale | Standard Deviation 14.824 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 545 | -3.70 Scores on a Scale | Standard Deviation 27.962 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 29 | -4.17 Scores on a Scale | Standard Deviation 17.236 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 29 | 5.56 Scores on a Scale | Standard Deviation 17.568 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 545 | -5.56 Scores on a Scale | Standard Deviation 24.056 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 1 | -1.67 Scores on a Scale | Standard Deviation 9.461 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 60 | -4.44 Scores on a Scale | Standard Deviation 15.587 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 180 | -4.76 Scores on a Scale | Standard Deviation 38.946 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 545 | -5.56 Scores on a Scale | Standard Deviation 19.245 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 365 | -12.50 Scores on a Scale | Standard Deviation 25.909 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 180 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 1 | -8.33 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 29 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 60 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 90 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 180 | -16.67 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 270 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 365 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 545 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 730 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 1 | -6.67 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 29 | 6.67 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 60 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 90 | 6.67 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 180 | -6.67 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 270 | 6.67 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 365 | 6.67 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 545 | 6.67 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 730 | 6.67 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 1 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 29 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 60 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 90 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 270 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 365 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 545 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 730 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 1 | 0.00 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 29 | -11.11 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 60 | 11.11 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 90 | -11.11 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 180 | 22.22 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 270 | -11.11 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 365 | -11.11 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 545 | -11.11 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 730 | -11.11 Scores on a Scale | — |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 180 | 15.56 Scores on a Scale | Standard Deviation 27.756 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 730 | 20.83 Scores on a Scale | Standard Deviation 29.463 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 545 | -41.67 Scores on a Scale | Standard Deviation 82.496 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 29 | 16.67 Scores on a Scale | Standard Deviation 11.785 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 90 | -37.04 Scores on a Scale | Standard Deviation 12.83 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 90 | 11.11 Scores on a Scale | Standard Deviation 23.413 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 545 | 0.00 Scores on a Scale | Standard Deviation 47.14 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 730 | -16.67 Scores on a Scale | Standard Deviation 7.857 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 365 | 30.56 Scores on a Scale | Standard Deviation 26.788 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 1 | -20.00 Scores on a Scale | Standard Deviation 30.832 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 180 | -37.04 Scores on a Scale | Standard Deviation 23.13 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 730 | 3.33 Scores on a Scale | Standard Deviation 42.426 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 545 | 13.33 Scores on a Scale | Standard Deviation 47.14 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 270 | 25.00 Scores on a Scale | Standard Deviation 22.048 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 60 | -2.22 Scores on a Scale | Standard Deviation 10.184 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 1 | 8.33 Scores on a Scale | Standard Deviation 25.685 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 270 | -29.63 Scores on a Scale | Standard Deviation 42.066 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 270 | 24.44 Scores on a Scale | Standard Deviation 27.756 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 180 | 25.00 Scores on a Scale | Standard Deviation 22.048 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 545 | -5.56 Scores on a Scale | Standard Deviation 23.57 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 90 | 22.22 Scores on a Scale | Standard Deviation 41.107 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 29 | -13.89 Scores on a Scale | Standard Deviation 27.778 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 365 | -44.44 Scores on a Scale | Standard Deviation 22.222 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 365 | 22.22 Scores on a Scale | Standard Deviation 38.49 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 90 | 11.11 Scores on a Scale | Standard Deviation 19.245 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 29 | -8.33 Scores on a Scale | Standard Deviation 16.667 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 60 | 33.33 Scores on a Scale | Standard Deviation 44.096 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 365 | 22.22 Scores on a Scale | Standard Deviation 26.943 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 180 | 16.67 Scores on a Scale | Standard Deviation 28.868 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 1 | -2.67 Scores on a Scale | Standard Deviation 19.777 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 29 | 8.33 Scores on a Scale | Standard Deviation 21.517 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 730 | -16.67 Scores on a Scale | Standard Deviation 23.57 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 1 | -3.33 Scores on a Scale | Standard Deviation 13.944 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 60 | -14.81 Scores on a Scale | Standard Deviation 35.717 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 270 | 33.33 Scores on a Scale | Standard Deviation 44.096 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 60 | 13.89 Scores on a Scale | Standard Deviation 26.788 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 270 | 3.33 Scores on a Scale | Standard Deviation 7.454 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 545 | 9.33 Scores on a Scale | Standard Deviation 11.155 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 60 | 9.26 Scores on a Scale | Standard Deviation 8.784 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 365 | 6.67 Scores on a Scale | Standard Deviation 9.129 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 365 | 5.33 Scores on a Scale | Standard Deviation 11.926 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 545 | 3.33 Scores on a Scale | Standard Deviation 7.454 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 270 | -6.67 Scores on a Scale | Standard Deviation 31.972 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 180 | -2.22 Scores on a Scale | Standard Deviation 24.825 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 29 | -1.85 Scores on a Scale | Standard Deviation 14.299 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 730 | -4.17 Scores on a Scale | Standard Deviation 8.333 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 90 | -0.74 Scores on a Scale | Standard Deviation 18.692 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 1 | 1.23 Scores on a Scale | Standard Deviation 18.794 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 60 | -2.96 Scores on a Scale | Standard Deviation 10.062 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 29 | -8.15 Scores on a Scale | Standard Deviation 18.493 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 29 | 6.17 Scores on a Scale | Standard Deviation 14.815 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 1 | -3.70 Scores on a Scale | Standard Deviation 14.948 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 545 | -11.11 Scores on a Scale | Standard Deviation 15.713 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 60 | 0.00 Scores on a Scale | Standard Deviation 17.568 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 730 | -2.08 Scores on a Scale | Standard Deviation 21.916 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 545 | 1.67 Scores on a Scale | Standard Deviation 9.129 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 90 | -3.70 Scores on a Scale | Standard Deviation 22.906 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 365 | 3.33 Scores on a Scale | Standard Deviation 7.454 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 1 | -7.41 Scores on a Scale | Standard Deviation 12.108 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 180 | 0.00 Scores on a Scale | Standard Deviation 33.702 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 270 | 3.33 Scores on a Scale | Standard Deviation 9.501 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 180 | 2.78 Scores on a Scale | Standard Deviation 8.607 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 270 | -2.22 Scores on a Scale | Standard Deviation 34.605 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Global Health Status: Change from baseline Day 90 | 4.63 Scores on a Scale | Standard Deviation 8.448 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 730 | -8.33 Scores on a Scale | Standard Deviation 16.667 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 90 | 0.00 Scores on a Scale | Standard Deviation 8.333 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 60 | -1.85 Scores on a Scale | Standard Deviation 13.029 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 29 | -7.41 Scores on a Scale | Standard Deviation 12.108 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 180 | -5.56 Scores on a Scale | Standard Deviation 8.607 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Cognitive Functioning: Change from baseline Day 1 | -1.85 Scores on a Scale | Standard Deviation 10.015 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Fatigue: Change from baseline Day 365 | -13.33 Scores on a Scale | Standard Deviation 14.487 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | Physical Functioning: Change from baseline Day 730 | -3.33 Scores on a Scale | Standard Deviation 11.547 |
Secondary
Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores
The Functional Assessment of Cancer Treatment-Lymphoma Additional concerns subscale (FACT-LymS) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. Only the LYM subscale was administered in this study. The LYM items are scored on a 0 (Not at all) to 4 (Very much) response scale. Items are aggregated to a single score on a 0-60 scale. Lower scores indicate better health outcomes. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion.
Time frame: At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion.
Population: All participants in the JCAR017-treated set with completed baseline questionnaires and with at least one completed post-baseline questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 545 | 0.7 Scores on a Scale | Standard Deviation 7.14 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 730 | 1.4 Scores on a Scale | Standard Deviation 7.12 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 60 | -2.8 Scores on a Scale | Standard Deviation 5.42 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 270 | -0.3 Scores on a Scale | Standard Deviation 6.78 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 365 | 1.3 Scores on a Scale | Standard Deviation 7.01 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 180 | 0.6 Scores on a Scale | Standard Deviation 5.14 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 29 | -1.7 Scores on a Scale | Standard Deviation 7.14 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 1 | 0.7 Scores on a Scale | Standard Deviation 8.17 |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 90 | -0.4 Scores on a Scale | Standard Deviation 5.42 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 730 | -0.8 Scores on a Scale | Standard Deviation 1.33 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 270 | -3.7 Scores on a Scale | Standard Deviation 2.25 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 29 | -2.7 Scores on a Scale | Standard Deviation 4.56 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 60 | -2.0 Scores on a Scale | Standard Deviation 4.2 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 1 | 0.1 Scores on a Scale | Standard Deviation 7.05 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 545 | -3.7 Scores on a Scale | Standard Deviation 4.35 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 90 | -2.8 Scores on a Scale | Standard Deviation 3.83 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 365 | -3.3 Scores on a Scale | Standard Deviation 3.3 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 180 | -1.8 Scores on a Scale | Standard Deviation 5.65 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 29 | 1.3 Scores on a Scale | Standard Deviation 7.24 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 270 | -1.0 Scores on a Scale | Standard Deviation 10.07 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 90 | 0.6 Scores on a Scale | Standard Deviation 9.25 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 545 | -4.7 Scores on a Scale | Standard Deviation 4.16 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 730 | -1.8 Scores on a Scale | Standard Deviation 5.32 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 60 | -3.3 Scores on a Scale | Standard Deviation 9.99 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 365 | 2.0 Scores on a Scale | Standard Deviation 12.03 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 180 | -3.6 Scores on a Scale | Standard Deviation 10.2 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 1 | 1.9 Scores on a Scale | Standard Deviation 5.92 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 270 | -8.0 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 1 | 1.0 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 29 | -4.0 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 60 | -4.0 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 90 | -5.0 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 180 | 2.0 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 365 | -6.0 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 545 | -3.0 Scores on a Scale | — |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 730 | -2.0 Scores on a Scale | — |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 180 | -8.0 Scores on a Scale | Standard Deviation 7 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 90 | -6.7 Scores on a Scale | Standard Deviation 8.5 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 365 | -6.7 Scores on a Scale | Standard Deviation 10.69 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 60 | -4.7 Scores on a Scale | Standard Deviation 8.33 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 730 | -1.5 Scores on a Scale | Standard Deviation 12.02 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 545 | 3.5 Scores on a Scale | Standard Deviation 6.36 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 29 | -6.5 Scores on a Scale | Standard Deviation 8.1 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 1 | -4.0 Scores on a Scale | Standard Deviation 6.52 |
| Cohort 5: Primary Central Nervous System Lymphoma | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 270 | -10.00 Scores on a Scale | Standard Deviation 12.53 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 1 | -1.2 Scores on a Scale | Standard Deviation 11.08 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 90 | -1.7 Scores on a Scale | Standard Deviation 8.67 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 270 | 2.4 Scores on a Scale | Standard Deviation 5.22 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 730 | -1.5 Scores on a Scale | Standard Deviation 1.29 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 545 | -1.0 Scores on a Scale | Standard Deviation 4.85 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 365 | 1.4 Scores on a Scale | Standard Deviation 7.33 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 60 | -0.4 Scores on a Scale | Standard Deviation 9.95 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 180 | 1.0 Scores on a Scale | Standard Deviation 7.27 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma Additional Concerns Subscale (FACT-LymS) Scores | Change from baseline Day 29 | 1.0 Scores on a Scale | Standard Deviation 9.08 |
Secondary
Complete Response Rate (CRR)
Complete response rate is defined as percentage of participants achieving a best overall response of complete response. Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: None * New lesions: No * Bone marrow: Normal Complete response (CR) (Cohort 5): * Brain imaging: No contrast enhancement * Corticosteroid dose: None * Eye examination: Normal * Cerebrospinal fluid cytology: Negative Complete response unconfirmed (CRu) (Cohort 5): * Brain imaging: No contrast enhancement, Minimal abnormality * Corticosteroid dose: Any * Eye examination: Normal, minor RPE abnormality * Cerebrospinal fluid cytology: Negative
Time frame: From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)
Population: All participants in the JCAR017 treated set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Complete Response Rate (CRR) | 33.3 Percent of Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Complete Response Rate (CRR) | 48.1 Percent of Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Complete Response Rate (CRR) | 50.0 Percent of Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Complete Response Rate (CRR) | 0 Percent of Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Complete Response Rate (CRR) | 0 Percent of Participants |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Complete Response Rate (CRR) | 88.9 Percent of Participants |
Secondary
Duration of Response (DOR)
DOR is from first response (complete response (CR), CR unconfirmed (CRu) or partial response (PR)) to progression (PD) or death. Those without PD or death were censored at the last assessment. CR via PET-CT: Lymph/extralymph: Score 1/2/3a w/w-out resid mass, no new lesions, No FDG-avid disease in bone marrow (BM) CR via CT scan: Lymph/extralymph: Target/nodal ≤ 1.5 cm, no new lesions, normal BM CR Cohort 5: No contrast enhance, no corticosteroid, normal eye exam, neg CSF cytology CRu Cohort 5: No contrast enhance, min abnorm, normal eye exam, neg CSF cytology PR via PET-CT: Lymph/extralymph: Score 4/5b, red uptake, no new lesions, resid uptake incr, reduced in BM PR via CT scan: Lymph/extralymph: 50% decr in sum of diam ≤ 6 target/extranodal, no new/nonmeasured lesions, Organ enlarge: Spleen decr \> 50% PR Cohort 5: 50% decr in enhancing tumor, no contrast enhance, Eye exam: Minor abnorm, decr in vitreous cells/retinal infiltrate, negative, persist or suspic CSF cytology.
Time frame: From JCAR017 infusion until disease progression, death due to any reason, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)
Population: All participants in the JCAR017 treated set who achieved a best overall response of complete response (and/ or CRu in cohort 5) or partial response/ remission.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Duration of Response (DOR) | 3.83 Months |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Duration of Response (DOR) | 3.91 Months |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Duration of Response (DOR) | 9.07 Months |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Duration of Response (DOR) | 17.97 Months |
| Cohort 5: Primary Central Nervous System Lymphoma | Duration of Response (DOR) | 17.63 Months |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Duration of Response (DOR) | NA Months |
Secondary
Event Free Survival (EFS)
Event-free survival is from JCAR017 infusion to death from any cause, progressive disease, or starting a new anticancer therapy. If a participant did not have an EFS event prior to data cutoff, EFS was censored at last disease assessment. Progressive disease (PD): * Target nodes/nodal masses: PPD progression. * Extranodal lesion: LDi \> 1.5 cm and increase by ≥ 50% from PPD nadir. * Splenomegaly: \> 50% of prior increase from baseline or by at least 2 cm from baseline. * Nonmeasured lesions: New or clear progression. * New lesions: Regrowth of previously resolved lesions. * Bone marrow: New or recurrent Progressive Disease (Cohort 5): * Brain imaging: \> 25% increase in enhancing lesion from baseline or best response. * Eye Exam: Increased vitreous cell counts or progressive retinal or optic nerve infiltration. * New lesion or site of disease
Time frame: From JCAR017 infusion to death due to any reason, progressive disease, or starting a new anticancer therapy (up to approximately 63 months).
Population: All participants in the JCAR017 treated set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Event Free Survival (EFS) | 2.99 Months |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Event Free Survival (EFS) | 3.12 Months |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Event Free Survival (EFS) | 6.33 Months |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Event Free Survival (EFS) | 23.95 Months |
| Cohort 5: Primary Central Nervous System Lymphoma | Event Free Survival (EFS) | 14.23 Months |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Event Free Survival (EFS) | NA Months |
Secondary
Maximum Concentration (Cmax) of JCAR017 by qPCR
Cmax is the maximum or peak concentration of drug reached in the plasma following a dose of the drug. Quantitative polymerase chain reaction (qPCR) was used to determine Cmax by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion.
Time frame: At baseline and up until 24 months post JCAR017 infusion
Population: All participants in the JCAR017 treated set with baseline and on-study PK measurements.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Maximum Concentration (Cmax) of JCAR017 by qPCR | 23132.1 Copies/ug | Geometric Coefficient of Variation 434.6 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Maximum Concentration (Cmax) of JCAR017 by qPCR | 21960.0 Copies/ug | Geometric Coefficient of Variation 278.1 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Maximum Concentration (Cmax) of JCAR017 by qPCR | 17337.8 Copies/ug | Geometric Coefficient of Variation 894.4 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Maximum Concentration (Cmax) of JCAR017 by qPCR | 51121.0 Copies/ug | — |
| Cohort 5: Primary Central Nervous System Lymphoma | Maximum Concentration (Cmax) of JCAR017 by qPCR | 7661.6 Copies/ug | Geometric Coefficient of Variation 1730 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Maximum Concentration (Cmax) of JCAR017 by qPCR | 32027.1 Copies/ug | Geometric Coefficient of Variation 101.4 |
Secondary
Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Time frame: From leukapheresis to end of study (up to approximately 63 months)
Population: All participants in the JCAR017 treated set. Prespecified to be reported for Cohorts 1, 2, 3, 4, and 5 only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between Day 31 and Day 90 | 25 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC) | 5 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between Day 91 and end of study | 10 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between LDC and JCAR017 infusion | 29 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between JCAR017 infusion and Day 30 | 36 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between Day 31 and Day 90 | 10 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between JCAR017 infusion and Day 30 | 26 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between LDC and JCAR017 infusion | 23 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between Day 91 and end of study | 9 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC) | 5 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between JCAR017 infusion and Day 30 | 10 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC) | 0 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between LDC and JCAR017 infusion | 8 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between Day 31 and Day 90 | 8 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between Day 91 and end of study | 7 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between Day 91 and end of study | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC) | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between Day 31 and Day 90 | 1 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between JCAR017 infusion and Day 30 | 1 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between LDC and JCAR017 infusion | 0 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between JCAR017 infusion and Day 30 | 5 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between Day 31 and Day 90 | 3 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC) | 0 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between Day 91 and end of study | 2 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | AEs occurring between LDC and JCAR017 infusion | 4 Participants |
Secondary
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death.
Time frame: At Baseline and Day 29 after JCAR017 infusion
Population: All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Activated Partial Thromboplastin Time (sec) - Day 29 | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Leukocytes (10^9/L) - Day 29 | 4 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Prothrombin Intl. Normalized Ratio - Day 29 | 1 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Neutrophils, Segmented (10^9/L) - Day 29 | 11 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Platelets (10^9/L) - Day 29 | 13 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Activated Partial Thromboplastin Time (sec) - Day 29 | 1 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Platelets (10^9/L) - Day 29 | 8 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Neutrophils, Segmented (10^9/L) - Day 29 | 6 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Prothrombin Intl. Normalized Ratio - Day 29 | 0 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Leukocytes (10^9/L) - Day 29 | 2 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Platelets (10^9/L) - Day 29 | 9 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Leukocytes (10^9/L) - Day 29 | 1 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Neutrophils, Segmented (10^9/L) - Day 29 | 3 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Activated Partial Thromboplastin Time (sec) - Day 29 | 1 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Prothrombin Intl. Normalized Ratio - Day 29 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Prothrombin Intl. Normalized Ratio - Day 29 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Leukocytes (10^9/L) - Day 29 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Activated Partial Thromboplastin Time (sec) - Day 29 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Platelets (10^9/L) - Day 29 | 1 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Neutrophils, Segmented (10^9/L) - Day 29 | 0 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Platelets (10^9/L) - Day 29 | 3 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Activated Partial Thromboplastin Time (sec) - Day 29 | 1 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Leukocytes (10^9/L) - Day 29 | 1 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Prothrombin Intl. Normalized Ratio - Day 29 | 0 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | Neutrophils, Segmented (10^9/L) - Day 29 | 1 Participants |
Secondary
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death.
Time frame: At Baseline and Day 29 after JCAR017 infusion
Population: All participants in the JCAR017 treated set with available baseline and Day 29 serum chemistry results. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Triglycerides (mmol/L) - Day 29 | 10 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Creatinine (umol/L) - Day 29 | 23 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Alkaline Phosphatase (U/L) - Day 29 | 2 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Bilirubin (umol/L) - Day 29 | 2 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Alanine Aminotransferase (U/L) - Day 29 | 10 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Urate (umol/L) - Day 29 | 1 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Aspartate Aminotransferase (U/L) - Day 29 | 6 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Phosphate (mmol/L) - Day 29 | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Albumin (g/L) - Day 29 | 0 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Bilirubin (umol/L) - Day 29 | 0 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Creatinine (umol/L) - Day 29 | 20 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Phosphate (mmol/L) - Day 29 | 1 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Albumin (g/L) - Day 29 | 0 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Urate (umol/L) - Day 29 | 0 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Alkaline Phosphatase (U/L) - Day 29 | 1 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Alanine Aminotransferase (U/L) - Day 29 | 3 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Aspartate Aminotransferase (U/L) - Day 29 | 3 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Triglycerides (mmol/L) - Day 29 | 6 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Alanine Aminotransferase (U/L) - Day 29 | 1 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Phosphate (mmol/L) - Day 29 | 0 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Triglycerides (mmol/L) - Day 29 | 2 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Creatinine (umol/L) - Day 29 | 6 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Bilirubin (umol/L) - Day 29 | 0 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Aspartate Aminotransferase (U/L) - Day 29 | 1 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Albumin (g/L) - Day 29 | 0 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Alkaline Phosphatase (U/L) - Day 29 | 0 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Urate (umol/L) - Day 29 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Urate (umol/L) - Day 29 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Albumin (g/L) - Day 29 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Phosphate (mmol/L) - Day 29 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Alkaline Phosphatase (U/L) - Day 29 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Alanine Aminotransferase (U/L) - Day 29 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Aspartate Aminotransferase (U/L) - Day 29 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Bilirubin (umol/L) - Day 29 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Creatinine (umol/L) - Day 29 | 1 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Triglycerides (mmol/L) - Day 29 | 0 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Bilirubin (umol/L) - Day 29 | 0 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Aspartate Aminotransferase (U/L) - Day 29 | 3 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Alanine Aminotransferase (U/L) - Day 29 | 2 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Urate (umol/L) - Day 29 | 0 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Triglycerides (mmol/L) - Day 29 | 2 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Alkaline Phosphatase (U/L) - Day 29 | 1 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Phosphate (mmol/L) - Day 29 | 0 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Albumin (g/L) - Day 29 | 0 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | Creatinine (umol/L) - Day 29 | 3 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5
A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Time frame: From leukapheresis to end of study (up to approximately 63 months)
Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between Day 31 and Day 90 | 7 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC) | 0 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between Day 91 and end of study | 5 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between LDC and JCAR017 infusion | 1 Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between JCAR017 infusion and Day 30 | 16 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between Day 31 and Day 90 | 3 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between JCAR017 infusion and Day 30 | 7 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between LDC and JCAR017 infusion | 0 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between Day 91 and end of study | 3 Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC) | 1 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between JCAR017 infusion and Day 30 | 0 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC) | 0 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between LDC and JCAR017 infusion | 0 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between Day 31 and Day 90 | 2 Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between Day 91 and end of study | 1 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between Day 91 and end of study | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC) | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between Day 31 and Day 90 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between JCAR017 infusion and Day 30 | 0 Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between LDC and JCAR017 infusion | 0 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between JCAR017 infusion and Day 30 | 1 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between Day 31 and Day 90 | 1 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC) | 0 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between Day 91 and end of study | 0 Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | SAEs occurring between LDC and JCAR017 infusion | 0 Participants |
Secondary
Overall Response Rate (ORR) in Cohort 7
ORR by Independent Review Committee. ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: None * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: None/normal * Organ enlargement: Spleen length decreased \> 50% * New lesions: No
Time frame: From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)
Population: All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Overall Response Rate (ORR) in Cohort 7 | 88.9 Percent of Participants |
Secondary
Overall Survival (OS)
Overall survival is defined as the interval from the date of JCAR017 infusion to the date of death due to any reason. Data from surviving participants was censored at the last time that the participant was known to be alive. Estimated using Kaplan-Meier product-limit estimates.
Time frame: From the date of JCAR017 infusion to the date of death due to any reason (up to approximately 63 months).
Population: All participants in the JCAR017 treated set.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Overall Survival (OS) | 15.84 Months |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Overall Survival (OS) | 16.82 Months |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Overall Survival (OS) | 14.72 Months |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Overall Survival (OS) | 31.74 Months |
| Cohort 5: Primary Central Nervous System Lymphoma | Overall Survival (OS) | 14.23 Months |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Overall Survival (OS) | NA Months |
Secondary
Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR
Persistence is defined as a transgene count greater than or equal to the lower limit of detection (LLOD) of 5 copies per reaction. Data obtained after the start of a new anti-cancer therapy were excluded. qPCR = Quantitative polymerase chain reaction.
Time frame: At Day 29 and Months 2, 3, 6, 9, 12, 18, and 24 post JCAR017 infusion.
Population: All participants in the JCAR017 treated set with baseline and on-study JCAR017 transgene results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 12 | 40.0 Percent of Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 6 | 33.3 Percent of Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Day 29 | 88.2 Percent of Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 2 | 70.0 Percent of Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 9 | 41.7 Percent of Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 24 | 28.6 Percent of Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 18 | 25.0 Percent of Participants |
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 3 | 61.5 Percent of Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 3 | 50.0 Percent of Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 6 | 45.5 Percent of Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Day 29 | 95.2 Percent of Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 24 | 50.0 Percent of Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 2 | 66.7 Percent of Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 18 | 57.1 Percent of Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 12 | 57.1 Percent of Participants |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 9 | 40.0 Percent of Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 3 | 100.0 Percent of Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 12 | 100.0 Percent of Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 18 | 75.0 Percent of Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 2 | 100.0 Percent of Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 24 | 100.0 Percent of Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 6 | 71.4 Percent of Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Day 29 | 100.0 Percent of Participants |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 9 | 60.0 Percent of Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Day 29 | 100.0 Percent of Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 12 | 0.0 Percent of Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 2 | 100.0 Percent of Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 24 | 0.0 Percent of Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 18 | 0.0 Percent of Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 3 | 100.0 Percent of Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 9 | 0.0 Percent of Participants |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 6 | 0.0 Percent of Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 2 | 100.0 Percent of Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 12 | 66.7 Percent of Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Day 29 | 80.0 Percent of Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 3 | 100.0 Percent of Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 6 | 100.0 Percent of Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 9 | 100.0 Percent of Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 18 | 100.0 Percent of Participants |
| Cohort 5: Primary Central Nervous System Lymphoma | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 24 | 100.0 Percent of Participants |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 24 | 20.0 Percent of Participants |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 18 | 20.0 Percent of Participants |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 6 | 16.7 Percent of Participants |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 3 | 37.5 Percent of Participants |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 2 | 62.5 Percent of Participants |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Day 29 | 100.0 Percent of Participants |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 12 | 0.0 Percent of Participants |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Month 9 | 25.0 Percent of Participants |
Secondary
Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria
Progression-free survival is defined as the interval from the date of JCAR017 infusion to progressive disease or death due to any cause, whichever occurred first. Per European Medicines Agency (EMA) criteria, participants who did not experience progressive disease and who did not die before the data cutoff date were censored at the time of the last visit with adequate response assessment when the participants were known not to have progressed. Estimated using Kaplan-Meier product-limit estimates.
Time frame: From JCAR017 infusion to progressive disease or death due to any reason, whichever occurred first (up to approximately 63 months)
Population: All participants in the JCAR017 treated set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria | 2.99 Months |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria | 3.12 Months |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria | 6.33 Months |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria | 14.23 Months |
| Cohort 5: Primary Central Nervous System Lymphoma | Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria | 23.95 Months |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria | NA Months |
Secondary
Time to Peak Concentration (Tmax) of JCAR017 by qPCR
Time to maximum concentration (Tmax) is the time it takes for a drug to reach the maximum concentration (Cmax) after administration. Quantitative polymerase chain reaction (qPCR) was used to determine Tmax by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion.
Time frame: At baseline and up until 24 months post JCAR017 infusion
Population: All participants in the JCAR017 treated set with baseline and on-study PK measurements.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Time to Peak Concentration (Tmax) of JCAR017 by qPCR | 11.6 Days |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Time to Peak Concentration (Tmax) of JCAR017 by qPCR | 9.0 Days |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Time to Peak Concentration (Tmax) of JCAR017 by qPCR | 84.1 Days |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Time to Peak Concentration (Tmax) of JCAR017 by qPCR | 10.0 Days |
| Cohort 5: Primary Central Nervous System Lymphoma | Time to Peak Concentration (Tmax) of JCAR017 by qPCR | 9.0 Days |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Time to Peak Concentration (Tmax) of JCAR017 by qPCR | 12.2 Days |
Secondary
Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR
Area Under the Curve (AUC) represents the total exposure of participants to study drug. Quantitative polymerase chain reaction (qPCR) was used to determine AUC by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion.
Time frame: At baseline and up until 24 months post JCAR017 infusion
Population: All participants in the JCAR017 treated set with baseline and on-study PK measurements.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR | 185586.667 Days*copies/ug | Geometric Coefficient of Variation 325.6 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR | 157499.362 Days*copies/ug | Geometric Coefficient of Variation 211.9 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR | 134819.085 Days*copies/ug | Geometric Coefficient of Variation 1268.9 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR | 286119.439 Days*copies/ug | — |
| Cohort 5: Primary Central Nervous System Lymphoma | Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR | 64945.715 Days*copies/ug | Geometric Coefficient of Variation 1345.7 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR | 199731.737 Days*copies/ug | Geometric Coefficient of Variation 136.8 |