Lymphoma, Non-Hodgkin
Conditions
Keywords
Non-Hodgkin Lymphomas, DLBCL, Efficacy, Safety, JCAR017, Liso-cel, High-Risk, Relapsed, Refractory, B-cell NHL
Brief summary
The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B). All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP, RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT) and Hematopoietic stem cell transplant (HSCT). Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event. Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by JCAR017 infusion.
Interventions
DRUGStandard of Care
Standard of Care
GENETICJCAR017
JCAR017
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥ 18 years and ≤ 75 years of age at the time of signing the informed consent form (ICF). 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 3. Histologically proven diffuse large B-cell lymphoma (DLBCL) NOS (de novo or transformed indolent NHL), high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma \[DHL/THL\]), primary mediastinal (thymic) large B-cell lymphoma (PMBCL), T cell/histiocyte-rich large B-cell lymphoma (THRBCL) or follicular lymphoma grade 3B. Enough tumor material must be available for confirmation by central pathology. 4. Refractory or relapsed within 12 months from CD20 antibody and anthracycline containing first line therapy. 5. \[18F\] fluorodeoxyglucose (FDG) positron emission tomography (PET) positive lesion at screening. (Deauville score 4 or 5) 6. Adequate organ function 7. Participants must agree to use effective contraception
Exclusion criteria
1. Subjects not eligible for hematopoietic stem cell transplantation (HSCT). 2. Subjects planned to undergo allogeneic stem cell transplantation. 3. Subjects with, primary cutaneous large B-cell lymphoma, EBV (Epstein-Barr virus) positive DLBCL, Burkitt lymphoma or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter transformation). 4. Subjects with prior history of malignancies, other than aggressive R/R NHL, unless the subject has been free of the disease for ≥ 2 years with the exception of the following noninvasive malignancies: * Basal cell carcinoma of the skin * Squamous cell carcinoma of the skin * Carcinoma in situ of the cervix * Carcinoma in situ of the breast * Incidental histologic finding of prostate cancer (T1a or T1b using the TNM \[tumor, nodes, metastasis\] clinical staging system) or prostate cancer that is curative. * Other completely resected stage 1 solid tumor with low risk for recurrence 5. Treatment with any prior gene therapy product. 6. Subjects who have received previous CD19-targeted therapy. 7. Subjects with active hepatitis B, or active hepatitis C are excluded. Subjects with negative polymerase chain reaction (PCR) assay for viral load for hepatitis B or C are permitted. Subjects positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody with negative viral load are eligible and should be considered for prophylactic antiviral therapy. Subjects with a history of or active human immunodeficiency virus (HIV) are excluded. 8. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment. 9. Active autoimmune disease requiring immunosuppressive therapy. 10. History of any one of the following cardiovascular conditions within the past 6 months prior to signing the ICF: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease. 11. History or presence of clinically relevant central nervous system (CNS) pathology 12. Pregnant or nursing (lactating) women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free Survival (EFS) Per Independent Review Committee (IRC) | From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months) | Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. PD: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Response (CR) | From randomization up to 3 years post randomization (Up to 36 months) | The number of participants achieving a best overall response of complete response (CR). Participants with unknown or missing response will be counted as non-evaluable in the analysis. CR: Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, no extralymphatic sites, no new lesions. Complete metabolic response: Lymph nodes/extralymphatic sites score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. |
| Progression-free Survival (PFS) | From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months) | Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid. |
| Overall Survival (OS) | From randomization to time of death due to any cause (Up to 36 months) | Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates. |
| Overall Response Rate (ORR) | From randomization to PR or CR (Up to 36 months) | ORR is defined as the percentage of participants achieving a best overall response of partial response (PR) or complete response (CR). CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. |
| Duration of Response (DoR) Per Independent Review Committee (IRC) | From randomization to to disease progression, start of new antineoplastic therapy due to efficacy concerns or death, whichever occurs first (Up to 36 months) | DoR is defined as the time from first partial or complete response (CR or PR) to disease progression, start of new antineoplastic therapy due to efficacy concerns or death, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. PD: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid. |
| Number of Participants With Progression-free Survival on Next Line of Treatment (PFS-2) | From randomization to second objective progression, or death from any cause, whichever occurs first (Up to 36 months) | Progression-free Survival (PFS)-2 based on investigator's assessment is defined as time from randomization to second objective progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid. |
| Event-free Survival (EFS) Rate | Months 6, 12, 18, 24, 36 | EFS rate is defined as the percentage of participants free of any EFS event at fixed timepoints. Complete response: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. Partial response: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. Progression: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Metabolic progression: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid. |
| Progression-free Survival (PFS) Rate | Months 6, 12, 18, 24, 36 | Progression-free Survival (PFS) rate is defined as the percentage of participants free of any PFS event at fixed timepoints. Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid. |
| Overall Survival (OS) Rate | Months 6, 12, 18, 24, 36 | Overall Survival (OS) rate is defined as the percentage of participants alive at fixed timepoints. OS is defined as the time from randomization to death due to any cause. Participants alive or lost to follow up at the time of analysis will be censored at the last date the participants was known to be alive. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. TEAEs are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
| Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months) | A serious adverse event is defined as any adverse event occurring at any dose that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. Treatment emergent adverse events are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
| Change From Baseline in Hematology Parameters 1: Hemoglobin | baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36 | Change from baseline in hemoglobin. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). |
| Complete Response Rate (CRR) | From randomization up to 3 years post randomization (Up to 36 months) | Complete response rate (CRR) is defined as the percentage of participants achieving a best overall response of complete response (CR). Participants with unknown or missing response will be counted as non-evaluable in the analysis. CR: Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, no extralymphatic sites, no new lesions. Complete metabolic response: Lymph nodes/extralymphatic sites score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. |
| Change From Baseline in Selected Chemistry Parameters 1 | baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36 | Change from baseline in selected chemistry parameters such as alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). |
| Change From Baseline in Selected Chemistry Parameters 2 | baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36 | Change from baseline in selected chemistry parameters such as magnesium, phosphate, potassium, and sodium. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). |
| Overall Response Rate (ORR) by Subgroups | From randomization to PR or CR (Up to 36 months) | ORR is defined as the percentage of participants achieving a best overall response of partial response (PR) or complete response (CR). CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. |
| Event-free Survival (EFS) by Subgroups | From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months) | Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. PD: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid. |
| Progression-free Survival (PFS) by Subgroups | From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months) | Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid. |
| Overall Survival (OS) by Subgroups | From randomization to time of death due to any cause (Up to 36 months) | Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates. |
| Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | baseline, months 1, 6, 9, 12, 18, 24, 36 | Change from baseline in EORTC QLQ-C30 specified parameters including global health/quality of life, cognitive functioning, physical functioning, and fatigue. It is composed of both multi-item scales and single item measures. All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning. Symptom scale/item higher score represents a high level of symptomatic problem. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). |
| Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | baseline, months 1, 6, 9, 12, 18, 24, 36 | Change from Baseline in the Functional Assessment of Cancer Therapy-Lymphoma 15-item lymphoma-specific Additional concerns subscale (FACT-Lym). 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. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). A meaningful change from baseline in the FACT-Lym score, often referred to as the minimally important difference (MID), typically ranges between 6.5 and 11.2 points for the total score. This range indicates a clinically significant improvement or deterioration in a patient's health-related quality of life. |
| Hospital Resource Utilization (HRU) Results | Up to 36 months | Hospital resource utilization (HRU) results including hospitalized, reasons for hospitalizations, and admitted to intensive care unit (ICU) |
| Percentage of Participants Completing High Dose Chemotherapy (HDCT) | Up to 5 months after first dose | Percentage of Participants Completing High Dose Chemotherapy (HDCT). |
| Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT) | Up to 5 months after first dose | Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT). |
| Change From Baseline in Selected Hematology Parameters 2 | baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36 | Change from baseline in selected hematology parameters such as leukocytes, lymphocytes, neutrophils, and platelets. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). |
Countries
Belgium, Finland, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Arm 3 cycles of standard of care (SOC) salvage therapy (rituximab, dexamethasone, cytarabine and cisplatin \[R-DHAP\], rituximab, ifosfamide, carboplatin and etoposide \[R-ICE\], rituximab, gemcitabine, dexamethasone, and cisplatin \[R-GDP\]) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks | 92 |
| Liso-cel Arm \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy) | 92 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 2 | 2 |
| Overall Study | Death due to the COVID-19 pandemic | 0 | 1 |
| Overall Study | Disease relapse | 15 | 6 |
| Overall Study | Lack of Efficacy | 28 | 0 |
| Overall Study | other reasons | 5 | 0 |
| Overall Study | Physician Decision | 3 | 0 |
| Overall Study | Study drug manufacturing failure | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Liso-cel Arm | Total | Standard of Care Arm |
|---|---|---|---|
| Age, Continuous | 58.3 Years STANDARD_DEVIATION 12.61 | 56.3 Years STANDARD_DEVIATION 13.41 | 54.2 Years STANDARD_DEVIATION 13.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants | 127 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 24 Participants | 51 Participants | 27 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 10 Participants | 18 Participants | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Collected or Reported | 22 Participants | 47 Participants | 25 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 54 Participants | 109 Participants | 55 Participants |
| Sex: Female, Male Female | 48 Participants | 79 Participants | 31 Participants |
| Sex: Female, Male Male | 44 Participants | 105 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 9 / 31 | 34 / 92 | 33 / 61 |
| other Total, other adverse events | 30 / 30 | 92 / 92 | 57 / 61 |
| serious Total, serious adverse events | 21 / 30 | 43 / 92 | 19 / 61 |
Outcome results
Primary
Event-free Survival (EFS) Per Independent Review Committee (IRC)
Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. PD: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.
Time frame: From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months)
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Arm | Event-free Survival (EFS) Per Independent Review Committee (IRC) | 2.4 Months |
| Liso-cel Arm | Event-free Survival (EFS) Per Independent Review Committee (IRC) | 29.5 Months |
Secondary
Change From Baseline in Hematology Parameters 1: Hemoglobin
Change from baseline in hemoglobin. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).
Time frame: baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36
Population: All treated participants with a baseline value and a post-baseline value at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 12 | 6.17 g/L | Standard Deviation 14.598 |
| Standard of Care Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 4 | -22.00 g/L | — |
| Standard of Care Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 18 | 11.37 g/L | Standard Deviation 14.592 |
| Standard of Care Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 6 | -6.80 g/L | Standard Deviation 14.935 |
| Standard of Care Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 24 | 13.88 g/L | Standard Deviation 18.996 |
| Standard of Care Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 2 | -25.00 g/L | — |
| Standard of Care Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 36 | 14.41 g/L | Standard Deviation 16.978 |
| Standard of Care Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 3 | -30.83 g/L | Standard Deviation 19.013 |
| Standard of Care Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 9 | 0.36 g/L | Standard Deviation 19.242 |
| Standard of Care Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 1 | -16.98 g/L | Standard Deviation 13.408 |
| Liso-cel Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 36 | 13.63 g/L | Standard Deviation 12.417 |
| Liso-cel Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 1 | -14.94 g/L | Standard Deviation 14.628 |
| Liso-cel Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 3 | -15.78 g/L | Standard Deviation 19.41 |
| Liso-cel Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 6 | -3.16 g/L | Standard Deviation 19.755 |
| Liso-cel Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 9 | -0.52 g/L | Standard Deviation 15.632 |
| Liso-cel Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 12 | 3.32 g/L | Standard Deviation 15.417 |
| Liso-cel Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 18 | 7.38 g/L | Standard Deviation 12.854 |
| Liso-cel Arm | Change From Baseline in Hematology Parameters 1: Hemoglobin | Hemoglobin Month 24 | 7.38 g/L | Standard Deviation 16.986 |
Secondary
Change From Baseline in Selected Chemistry Parameters 1
Change from baseline in selected chemistry parameters such as alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).
Time frame: baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36
Population: All treated participants with a baseline value and a post-baseline value at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 18 Aspartate Aminotransferase | 4.90 U/L | Standard Deviation 7.663 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 24 Alanine Aminotransferase | 7.69 U/L | Standard Deviation 15.134 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 24 Aspartate Aminotransferase | 4.63 U/L | Standard Deviation 9.172 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 3 Alanine Aminotransferase | -3.40 U/L | Standard Deviation 22.295 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 36 Aspartate Aminotransferase | 9.06 U/L | Standard Deviation 15.117 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 36 Alanine Aminotransferase | 12.41 U/L | Standard Deviation 17.429 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 1 Lactate Dehydrogenase | -66.7 U/L | Standard Deviation 222.79 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 9 Alanine Aminotransferase | 2.43 U/L | Standard Deviation 20.165 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 2 Lactate Dehydrogenase | 27.0 U/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 3 Lactate Dehydrogenase | -57.2 U/L | Standard Deviation 377.22 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 1 Aspartate Aminotransferase | 3.38 U/L | Standard Deviation 16.624 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 4 Lactate Dehydrogenase | 117.0 U/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 6 Lactate Dehydrogenase | -85.5 U/L | Standard Deviation 310.71 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 2 Alanine Aminotransferase | 4.00 U/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 9 Lactate Dehydrogenase | -85.0 U/L | Standard Deviation 362.52 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 2 Aspartate Aminotransferase | 5.00 U/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 12 Lactate Dehydrogenase | -52.9 U/L | Standard Deviation 74.56 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 3 Aspartate Aminotransferase | -6.47 U/L | Standard Deviation 17.248 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 18 Lactate Dehydrogenase | -44.1 U/L | Standard Deviation 71.19 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 12 Alanine Aminotransferase | 0.72 U/L | Standard Deviation 23.542 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 24 Lactate Dehydrogenase | -45.6 U/L | Standard Deviation 75.04 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 4 Aspartate Aminotransferase | 3.00 U/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 36 Lactate Dehydrogenase | -46.0 U/L | Standard Deviation 85.14 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 1 Alanine Aminotransferase | 17.22 U/L | Standard Deviation 25.997 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 6 Aspartate Aminotransferase | 1.23 U/L | Standard Deviation 15.911 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 4 Alanine Aminotransferase | -3.00 U/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 9 Aspartate Aminotransferase | 3.68 U/L | Standard Deviation 12.549 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 18 Alanine Aminotransferase | 10.40 U/L | Standard Deviation 15.892 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 12 Aspartate Aminotransferase | -1.44 U/L | Standard Deviation 16.18 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 6 Alanine Aminotransferase | 2.81 U/L | Standard Deviation 21.067 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 36 Lactate Dehydrogenase | -59.9 U/L | Standard Deviation 124.62 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 1 Alanine Aminotransferase | -0.52 U/L | Standard Deviation 18.337 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 3 Alanine Aminotransferase | 2.53 U/L | Standard Deviation 13.246 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 6 Alanine Aminotransferase | 3.08 U/L | Standard Deviation 14.813 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 9 Alanine Aminotransferase | 5.23 U/L | Standard Deviation 16.66 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 12 Alanine Aminotransferase | 4.19 U/L | Standard Deviation 19.653 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 18 Alanine Aminotransferase | -0.45 U/L | Standard Deviation 10.943 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 24 Alanine Aminotransferase | 1.88 U/L | Standard Deviation 13.211 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 36 Alanine Aminotransferase | 13.98 U/L | Standard Deviation 104.054 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 1 Aspartate Aminotransferase | 2.03 U/L | Standard Deviation 17.526 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 3 Aspartate Aminotransferase | -1.24 U/L | Standard Deviation 8.8 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 6 Aspartate Aminotransferase | 1.78 U/L | Standard Deviation 8.55 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 9 Aspartate Aminotransferase | 2.12 U/L | Standard Deviation 10.355 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 12 Aspartate Aminotransferase | 1.88 U/L | Standard Deviation 13.2 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 18 Aspartate Aminotransferase | -1.22 U/L | Standard Deviation 7.452 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 24 Aspartate Aminotransferase | 0.90 U/L | Standard Deviation 10.757 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 36 Aspartate Aminotransferase | 14.95 U/L | Standard Deviation 94.651 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 1 Lactate Dehydrogenase | -14.0 U/L | Standard Deviation 203.18 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 3 Lactate Dehydrogenase | -84.1 U/L | Standard Deviation 183.29 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 6 Lactate Dehydrogenase | -53.7 U/L | Standard Deviation 183.53 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 9 Lactate Dehydrogenase | -62.0 U/L | Standard Deviation 186.25 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 12 Lactate Dehydrogenase | -41.9 U/L | Standard Deviation 207.3 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 18 Lactate Dehydrogenase | -50.8 U/L | Standard Deviation 133.31 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 1 | Month 24 Lactate Dehydrogenase | -63.3 U/L | Standard Deviation 148.25 |
Secondary
Change From Baseline in Selected Chemistry Parameters 2
Change from baseline in selected chemistry parameters such as magnesium, phosphate, potassium, and sodium. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).
Time frame: baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36
Population: All treated participants with a baseline value and a post-baseline value at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 1 phosphate | -0.061 mmol/L | Standard Deviation 0.2643 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 4 potassium | 0.80 mmol/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 6 potassium | 0.11 mmol/L | Standard Deviation 0.337 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 2 magnesium | -0.080 mmol/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 9 potassium | -0.06 mmol/L | Standard Deviation 0.447 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 2 phosphate | 0.030 mmol/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 12 potassium | 0.01 mmol/L | Standard Deviation 0.445 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 3 phosphate | -0.128 mmol/L | Standard Deviation 0.3299 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 18 potassium | 0.06 mmol/L | Standard Deviation 0.38 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 12 magnesium | 0.012 mmol/L | Standard Deviation 0.1047 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 24 potassium | 0.09 mmol/L | Standard Deviation 0.516 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 4 phosphate | 0.130 mmol/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 36 potassium | 0.07 mmol/L | Standard Deviation 0.549 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 6 phosphate | 0.140 mmol/L | Standard Deviation 0.2166 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 1 sodium | -2.75 mmol/L | Standard Deviation 3.493 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 4 magnesium | -0.200 mmol/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 2 sodium | -1.00 mmol/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 3 sodium | -1.86 mmol/L | Standard Deviation 4.496 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 9 phosphate | 0.025 mmol/L | Standard Deviation 0.202 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 4 sodium | -2.00 mmol/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 6 sodium | -0.42 mmol/L | Standard Deviation 2.514 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 18 magnesium | 0.033 mmol/L | Standard Deviation 0.0639 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 9 sodium | 0.52 mmol/L | Standard Deviation 2.108 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 12 phosphate | -0.021 mmol/L | Standard Deviation 0.1578 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 12 sodium | 0.33 mmol/L | Standard Deviation 2.114 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 6 magnesium | -0.041 mmol/L | Standard Deviation 0.1452 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 18 sodium | 0.45 mmol/L | Standard Deviation 2.964 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 18 phosphate | -0.025 mmol/L | Standard Deviation 0.2666 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 24 sodium | -1.00 mmol/L | Standard Deviation 3.246 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 24 magnesium | 0.040 mmol/L | Standard Deviation 0.1145 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 36 sodium | -0.44 mmol/L | Standard Deviation 2.229 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 1 magnesium | -0.023 mmol/L | Standard Deviation 0.1145 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 24 phosphate | -0.064 mmol/L | Standard Deviation 0.2469 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 3 magnesium | -0.063 mmol/L | Standard Deviation 0.121 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 36 phosphate | -0.044 mmol/L | Standard Deviation 0.2464 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 36 magnesium | 0.039 mmol/L | Standard Deviation 0.092 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 1 potassium | -0.08 mmol/L | Standard Deviation 0.4 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 9 magnesium | -0.027 mmol/L | Standard Deviation 0.1459 |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 2 potassium | 0.30 mmol/L | — |
| Standard of Care Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 3 potassium | -0.33 mmol/L | Standard Deviation 0.604 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 36 sodium | 0.25 mmol/L | Standard Deviation 3.432 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 1 magnesium | 0.009 mmol/L | Standard Deviation 0.0933 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 3 magnesium | 0.007 mmol/L | Standard Deviation 0.101 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 6 magnesium | 0.015 mmol/L | Standard Deviation 0.109 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 9 magnesium | 0.025 mmol/L | Standard Deviation 0.1079 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 12 magnesium | 0.031 mmol/L | Standard Deviation 0.1054 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 18 magnesium | 0.032 mmol/L | Standard Deviation 0.1065 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 24 magnesium | 0.015 mmol/L | Standard Deviation 0.1027 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 36 magnesium | 0.011 mmol/L | Standard Deviation 0.0751 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 1 phosphate | -0.038 mmol/L | Standard Deviation 0.2498 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 3 phosphate | 0.039 mmol/L | Standard Deviation 0.2316 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 6 phosphate | -0.020 mmol/L | Standard Deviation 0.2276 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 9 phosphate | -0.028 mmol/L | Standard Deviation 0.2098 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 12 phosphate | -0.090 mmol/L | Standard Deviation 0.2051 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 18 phosphate | -0.059 mmol/L | Standard Deviation 0.2224 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 24 phosphate | -0.061 mmol/L | Standard Deviation 0.2549 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 36 phosphate | -0.061 mmol/L | Standard Deviation 0.2053 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 1 potassium | -0.05 mmol/L | Standard Deviation 0.46 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 3 potassium | 0.00 mmol/L | Standard Deviation 0.428 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 6 potassium | 0.08 mmol/L | Standard Deviation 0.359 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 9 potassium | 0.12 mmol/L | Standard Deviation 0.391 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 12 potassium | 0.06 mmol/L | Standard Deviation 0.491 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 18 potassium | 0.15 mmol/L | Standard Deviation 0.411 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 24 potassium | 0.09 mmol/L | Standard Deviation 0.435 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | Month 36 potassium | 0.11 mmol/L | Standard Deviation 0.43 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 1 sodium | -1.09 mmol/L | Standard Deviation 2.875 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 3 sodium | 0.59 mmol/L | Standard Deviation 3.054 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 6 sodium | 0.33 mmol/L | Standard Deviation 3.222 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 9 sodium | -0.08 mmol/L | Standard Deviation 3.111 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 12 sodium | -0.34 mmol/L | Standard Deviation 4.046 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 18 sodium | 0.74 mmol/L | Standard Deviation 3.572 |
| Liso-cel Arm | Change From Baseline in Selected Chemistry Parameters 2 | month 24 sodium | 1.02 mmol/L | Standard Deviation 3.795 |
Secondary
Change From Baseline in Selected Hematology Parameters 2
Change from baseline in selected hematology parameters such as leukocytes, lymphocytes, neutrophils, and platelets. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).
Time frame: baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36
Population: All treated participants with a baseline value and a post-baseline value at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 1 lymphocytes | -0.2824 10^9 cells/L | Standard Deviation 0.43519 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 4 neutrophils | -1.160 10^9 cells/L | — |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 6 neutrophils | -1.648 10^9 cells/L | Standard Deviation 1.7635 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 2 leukocytes | -0.870 10^9 cells/L | — |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 9 neutrophils | -0.879 10^9 cells/L | Standard Deviation 2.9777 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 2 lymphocytes | -0.2100 10^9 cells/L | — |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 12 neutrophils | -0.822 10^9 cells/L | Standard Deviation 1.578 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 3 lymphocytes | -0.4216 10^9 cells/L | Standard Deviation 0.55872 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 18 neutrophils | -1.167 10^9 cells/L | Standard Deviation 1.3772 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 12 leukocytes | -0.427 10^9 cells/L | Standard Deviation 1.4093 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 24 neutrophils | -0.124 10^9 cells/L | Standard Deviation 2.5434 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 4 lymphocytes | -0.1700 10^9 cells/L | — |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 36 neutrophils | -0.404 10^9 cells/L | Standard Deviation 1.8392 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 6 lymphocytes | 0.1343 10^9 cells/L | Standard Deviation 0.38219 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 1 platelets | 13.9 10^9 cells/L | Standard Deviation 140.94 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 4 leukocytes | -1.180 10^9 cells/L | — |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 2 platelets | 13.0 10^9 cells/L | — |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 3 platelets | -189.5 10^9 cells/L | Standard Deviation 132.93 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 9 lymphocytes | 0.3264 10^9 cells/L | Standard Deviation 0.66121 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 4 platelets | -74.0 10^9 cells/L | — |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 6 platelets | -45.5 10^9 cells/L | Standard Deviation 94.13 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 18 leukocytes | -0.598 10^9 cells/L | Standard Deviation 1.6136 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 9 platelets | -57.0 10^9 cells/L | Standard Deviation 110.48 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 12 lymphocytes | 0.5089 10^9 cells/L | Standard Deviation 0.71831 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 12 platelets | -66.5 10^9 cells/L | Standard Deviation 85.82 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 6 leukocytes | -1.699 10^9 cells/L | Standard Deviation 1.9099 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 18 platelets | -68.0 10^9 cells/L | Standard Deviation 84.69 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 18 lymphocytes | 0.6942 10^9 cells/L | Standard Deviation 0.98993 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 24 platelets | -29.4 10^9 cells/L | Standard Deviation 103.87 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 24 leukocytes | 0.694 10^9 cells/L | Standard Deviation 3.0465 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 36 platelets | -45.2 10^9 cells/L | Standard Deviation 123.28 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 1 leukocytes | 0.815 10^9 cells/L | Standard Deviation 6.9413 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 24 lymphocytes | 0.8688 10^9 cells/L | Standard Deviation 1.12695 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 3 leukocytes | -3.445 10^9 cells/L | Standard Deviation 5.8845 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 36 lymphocytes | 1.2253 10^9 cells/L | Standard Deviation 1.20268 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 36 leukocytes | 0.761 10^9 cells/L | Standard Deviation 2.3637 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 1 neutrophils | 1.368 10^9 cells/L | Standard Deviation 6.5393 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 9 leukocytes | -0.710 10^9 cells/L | Standard Deviation 3.067 |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 2 neutrophils | -0.590 10^9 cells/L | — |
| Standard of Care Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 3 neutrophils | -0.621 10^9 cells/L | Standard Deviation 6.8377 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 36 platelets | -10.5 10^9 cells/L | Standard Deviation 72.79 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 1 leukocytes | -3.219 10^9 cells/L | Standard Deviation 2.4688 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 3 leukocytes | -2.234 10^9 cells/L | Standard Deviation 2.352 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 6 leukocytes | -1.853 10^9 cells/L | Standard Deviation 2.5876 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 9 leukocytes | -1.156 10^9 cells/L | Standard Deviation 3.3604 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 12 leukocytes | -1.138 10^9 cells/L | Standard Deviation 2.3772 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 18 leukocytes | -1.088 10^9 cells/L | Standard Deviation 2.8028 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 24 leukocytes | -0.806 10^9 cells/L | Standard Deviation 2.5709 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 36 leukocytes | -0.970 10^9 cells/L | Standard Deviation 3.0158 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 1 lymphocytes | -0.7380 10^9 cells/L | Standard Deviation 0.43499 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 3 lymphocytes | -0.1318 10^9 cells/L | Standard Deviation 0.43385 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 6 lymphocytes | -0.0845 10^9 cells/L | Standard Deviation 0.48047 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 9 lymphocytes | -0.0442 10^9 cells/L | Standard Deviation 0.39684 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 12 lymphocytes | 0.0097 10^9 cells/L | Standard Deviation 0.37252 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 18 lymphocytes | 0.2283 10^9 cells/L | Standard Deviation 0.55421 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 24 lymphocytes | 0.3298 10^9 cells/L | Standard Deviation 0.51386 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 36 lymphocytes | 0.3550 10^9 cells/L | Standard Deviation 0.55387 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 1 neutrophils | -2.065 10^9 cells/L | Standard Deviation 2.3479 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 3 neutrophils | -1.909 10^9 cells/L | Standard Deviation 2.1727 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 6 neutrophils | -1.584 10^9 cells/L | Standard Deviation 2.4539 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 9 neutrophils | -1.001 10^9 cells/L | Standard Deviation 3.1318 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 12 neutrophils | -1.035 10^9 cells/L | Standard Deviation 2.2898 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 18 neutrophils | -1.189 10^9 cells/L | Standard Deviation 2.6342 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 24 neutrophils | -0.998 10^9 cells/L | Standard Deviation 2.5506 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 36 neutrophils | -0.998 10^9 cells/L | Standard Deviation 2.5222 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 1 platelets | 29.4 10^9 cells/L | Standard Deviation 115.53 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 3 platelets | -65.7 10^9 cells/L | Standard Deviation 100.52 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 6 platelets | -48.2 10^9 cells/L | Standard Deviation 89.04 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 9 platelets | -48.9 10^9 cells/L | Standard Deviation 89.29 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 12 platelets | -42.4 10^9 cells/L | Standard Deviation 92.65 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 18 platelets | -32.6 10^9 cells/L | Standard Deviation 81.68 |
| Liso-cel Arm | Change From Baseline in Selected Hematology Parameters 2 | Month 24 platelets | -28.7 10^9 cells/L | Standard Deviation 79.7 |
Secondary
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
Change from baseline in EORTC QLQ-C30 specified parameters including global health/quality of life, cognitive functioning, physical functioning, and fatigue. It is composed of both multi-item scales and single item measures. All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning. Symptom scale/item higher score represents a high level of symptomatic problem. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).
Time frame: baseline, months 1, 6, 9, 12, 18, 24, 36
Population: All treated participants with a health-related quality of life baseline assessment value and a post-baseline value at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 1 | -8.94 score on a scale | Standard Deviation 19.867 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 1 | -8.54 score on a scale | Standard Deviation 19.047 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 18 | 14.81 score on a scale | Standard Deviation 29.397 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 6 | -3.33 score on a scale | Standard Deviation 14.365 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 9 | -3.03 score on a scale | Standard Deviation 16.361 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 6 | -2.08 score on a scale | Standard Deviation 11.081 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 12 | -4.17 score on a scale | Standard Deviation 7.715 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 12 | 15.63 score on a scale | Standard Deviation 32.865 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 18 | 0.00 score on a scale | Standard Deviation 18.634 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 9 | 0.61 score on a scale | Standard Deviation 9.167 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 24 | 0.00 score on a scale | Standard Deviation 13.608 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 24 | 12.50 score on a scale | Standard Deviation 28.934 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 36 | -1.67 score on a scale | Standard Deviation 9.461 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 12 | 10.00 score on a scale | Standard Deviation 17.817 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 1 | 19.24 score on a scale | Standard Deviation 24.848 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 9 | 5.30 score on a scale | Standard Deviation 24.516 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 6 | 0.69 score on a scale | Standard Deviation 27.657 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 18 | 13.33 score on a scale | Standard Deviation 22.608 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 9 | -4.04 score on a scale | Standard Deviation 29.09 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 36 | 15.00 score on a scale | Standard Deviation 21.802 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 12 | -6.94 score on a scale | Standard Deviation 8.267 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 24 | 10.67 score on a scale | Standard Deviation 18.645 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 18 | -6.17 score on a scale | Standard Deviation 22.299 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 6 | -2.78 score on a scale | Standard Deviation 24.734 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 24 | -6.67 score on a scale | Standard Deviation 19.03 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 36 | 7.33 score on a scale | Standard Deviation 15.54 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 36 | -3.33 score on a scale | Standard Deviation 16.605 |
| Standard of Care Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 1 | -9.55 score on a scale | Standard Deviation 25.655 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 36 | -5.33 score on a scale | Standard Deviation 25.884 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 1 | -5.23 score on a scale | Standard Deviation 18.004 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 6 | 12.36 score on a scale | Standard Deviation 23.635 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 9 | 12.50 score on a scale | Standard Deviation 22.252 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 12 | 8.93 score on a scale | Standard Deviation 24.525 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 6 | 3.45 score on a scale | Standard Deviation 20.596 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 18 | 8.33 score on a scale | Standard Deviation 23.442 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 24 | 7.29 score on a scale | Standard Deviation 23.093 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Global Health/Quality of Life Month 36 | 2.67 score on a scale | Standard Deviation 21.071 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 1 | -4.03 score on a scale | Standard Deviation 16.339 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 6 | 2.24 score on a scale | Standard Deviation 17.47 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 9 | 5.00 score on a scale | Standard Deviation 21.825 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 12 | 4.52 score on a scale | Standard Deviation 17.875 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 18 | 1.73 score on a scale | Standard Deviation 17.027 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 24 | 2.78 score on a scale | Standard Deviation 22.147 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Physical Functioning Month 36 | -1.87 score on a scale | Standard Deviation 16.613 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 1 | -0.39 score on a scale | Standard Deviation 16.462 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 9 | 9.72 score on a scale | Standard Deviation 23.008 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 12 | 4.17 score on a scale | Standard Deviation 27.074 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 18 | 4.17 score on a scale | Standard Deviation 26.58 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 24 | 0.00 score on a scale | Standard Deviation 26.919 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Cognitive Functioning Month 36 | 2.67 score on a scale | Standard Deviation 17.795 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 1 | 0.26 score on a scale | Standard Deviation 20.501 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 6 | -12.84 score on a scale | Standard Deviation 29.811 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 9 | -10.65 score on a scale | Standard Deviation 36.702 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 12 | -9.52 score on a scale | Standard Deviation 33.363 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 18 | -10.22 score on a scale | Standard Deviation 30.919 |
| Liso-cel Arm | Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Fatigue Month 24 | -8.80 score on a scale | Standard Deviation 30.557 |
Secondary
Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym)
Change from Baseline in the Functional Assessment of Cancer Therapy-Lymphoma 15-item lymphoma-specific Additional concerns subscale (FACT-Lym). 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. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). A meaningful change from baseline in the FACT-Lym score, often referred to as the minimally important difference (MID), typically ranges between 6.5 and 11.2 points for the total score. This range indicates a clinically significant improvement or deterioration in a patient's health-related quality of life.
Time frame: baseline, months 1, 6, 9, 12, 18, 24, 36
Population: All treated participants with a health-related quality of life baseline assessment value and a post-baseline value at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 9 | 0.11 score on a scale | Standard Deviation 9.597 |
| Standard of Care Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 18 | 3.50 score on a scale | Standard Deviation 5.632 |
| Standard of Care Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 6 | 2.19 score on a scale | Standard Deviation 9.474 |
| Standard of Care Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 24 | 5.20 score on a scale | Standard Deviation 5.789 |
| Standard of Care Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 12 | 5.43 score on a scale | Standard Deviation 3.645 |
| Standard of Care Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 36 | 4.90 score on a scale | Standard Deviation 5.152 |
| Standard of Care Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 1 | -0.76 score on a scale | Standard Deviation 5.558 |
| Liso-cel Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 36 | 0.50 score on a scale | Standard Deviation 9.478 |
| Liso-cel Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 1 | 0.35 score on a scale | Standard Deviation 7.329 |
| Liso-cel Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 6 | 3.52 score on a scale | Standard Deviation 10.805 |
| Liso-cel Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 9 | 5.48 score on a scale | Standard Deviation 14.33 |
| Liso-cel Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 12 | 3.93 score on a scale | Standard Deviation 13.485 |
| Liso-cel Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 18 | 2.56 score on a scale | Standard Deviation 12.149 |
| Liso-cel Arm | Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym) | Month 24 | 2.18 score on a scale | Standard Deviation 12.374 |
Secondary
Complete Response Rate (CRR)
Complete response rate (CRR) is defined as the percentage of participants achieving a best overall response of complete response (CR). Participants with unknown or missing response will be counted as non-evaluable in the analysis. CR: Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, no extralymphatic sites, no new lesions. Complete metabolic response: Lymph nodes/extralymphatic sites score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease.
Time frame: From randomization up to 3 years post randomization (Up to 36 months)
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care Arm | Complete Response Rate (CRR) | 43.5 Percentage of participants |
| Liso-cel Arm | Complete Response Rate (CRR) | 73.9 Percentage of participants |
Secondary
Duration of Response (DoR) Per Independent Review Committee (IRC)
DoR is defined as the time from first partial or complete response (CR or PR) to disease progression, start of new antineoplastic therapy due to efficacy concerns or death, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. PD: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.
Time frame: From randomization to to disease progression, start of new antineoplastic therapy due to efficacy concerns or death, whichever occurs first (Up to 36 months)
Population: All randomized participants with PR or CR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Arm | Duration of Response (DoR) Per Independent Review Committee (IRC) | 9.1 Months |
| Liso-cel Arm | Duration of Response (DoR) Per Independent Review Committee (IRC) | NA Months |
Secondary
Event-free Survival (EFS) by Subgroups
Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. PD: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.
Time frame: From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months)
Population: All randomized participants per clinical, histological and molecular subgroups that are pre-specified for EFS (subgroups are not mutually exclusive)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard of Care Arm | Event-free Survival (EFS) by Subgroups | DLBCL: DLBCL from Transformed Indolent NHL | 2.1 Months |
| Standard of Care Arm | Event-free Survival (EFS) by Subgroups | NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma | NA Months |
| Standard of Care Arm | Event-free Survival (EFS) by Subgroups | DLBCL: Germinal Center B-cell like (GCB) | 2.1 Months |
| Standard of Care Arm | Event-free Survival (EFS) by Subgroups | NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma | 2.2 Months |
| Standard of Care Arm | Event-free Survival (EFS) by Subgroups | DLBCL: Activated B-cell-like, non-GCB | 2.3 Months |
| Standard of Care Arm | Event-free Survival (EFS) by Subgroups | Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo | 4.4 Months |
| Standard of Care Arm | Event-free Survival (EFS) by Subgroups | NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL) | 2.1 Months |
| Standard of Care Arm | Event-free Survival (EFS) by Subgroups | NIH: High-Grade B-cell Lymphoma with DLBCL Histology | 2.2 Months |
| Standard of Care Arm | Event-free Survival (EFS) by Subgroups | NHL: Non-DHL/THL | 2.8 Months |
| Standard of Care Arm | Event-free Survival (EFS) by Subgroups | Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) | 3.0 Months |
| Liso-cel Arm | Event-free Survival (EFS) by Subgroups | NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL) | 4.6 Months |
| Liso-cel Arm | Event-free Survival (EFS) by Subgroups | NHL: Non-DHL/THL | NA Months |
| Liso-cel Arm | Event-free Survival (EFS) by Subgroups | Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) | NA Months |
| Liso-cel Arm | Event-free Survival (EFS) by Subgroups | NIH: Follicular Lymphoma Grade 3B | NA Months |
| Liso-cel Arm | Event-free Survival (EFS) by Subgroups | NIH: High-Grade B-cell Lymphoma with DLBCL Histology | 4.6 Months |
| Liso-cel Arm | Event-free Survival (EFS) by Subgroups | NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma | NA Months |
| Liso-cel Arm | Event-free Survival (EFS) by Subgroups | NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma | NA Months |
| Liso-cel Arm | Event-free Survival (EFS) by Subgroups | Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo | 33.2 Months |
| Liso-cel Arm | Event-free Survival (EFS) by Subgroups | DLBCL: DLBCL from Transformed Indolent NHL | NA Months |
| Liso-cel Arm | Event-free Survival (EFS) by Subgroups | DLBCL: Germinal Center B-cell like (GCB) | 11.7 Months |
| Liso-cel Arm | Event-free Survival (EFS) by Subgroups | DLBCL: Activated B-cell-like, non-GCB | 33.2 Months |
Secondary
Event-free Survival (EFS) Rate
EFS rate is defined as the percentage of participants free of any EFS event at fixed timepoints. Complete response: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. Partial response: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. Progression: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Metabolic progression: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.
Time frame: Months 6, 12, 18, 24, 36
Population: All randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care Arm | Event-free Survival (EFS) Rate | EFS Rate at 12 months | 22.6 Percentage of participants |
| Standard of Care Arm | Event-free Survival (EFS) Rate | EFS Rate at 24 months | 21.5 Percentage of participants |
| Standard of Care Arm | Event-free Survival (EFS) Rate | EFS Rate at 18 months | 22.6 Percentage of participants |
| Standard of Care Arm | Event-free Survival (EFS) Rate | EFS Rate at 36 months | 19.1 Percentage of participants |
| Standard of Care Arm | Event-free Survival (EFS) Rate | EFS Rate at 6 months | 36.2 Percentage of participants |
| Liso-cel Arm | Event-free Survival (EFS) Rate | EFS Rate at 36 months | 45.8 Percentage of participants |
| Liso-cel Arm | Event-free Survival (EFS) Rate | EFS Rate at 6 months | 68.1 Percentage of participants |
| Liso-cel Arm | Event-free Survival (EFS) Rate | EFS Rate at 12 months | 57.0 Percentage of participants |
| Liso-cel Arm | Event-free Survival (EFS) Rate | EFS Rate at 18 months | 52.6 Percentage of participants |
| Liso-cel Arm | Event-free Survival (EFS) Rate | EFS Rate at 24 months | 51.4 Percentage of participants |
Secondary
Hospital Resource Utilization (HRU) Results
Hospital resource utilization (HRU) results including hospitalized, reasons for hospitalizations, and admitted to intensive care unit (ICU)
Time frame: Up to 36 months
Population: All participants treated in any study medication
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care Arm | Hospital Resource Utilization (HRU) Results | Hospitalized due to Progression of Disease | 2 Participants |
| Standard of Care Arm | Hospital Resource Utilization (HRU) Results | Hospitalized due to other reasons | 56 Participants |
| Standard of Care Arm | Hospital Resource Utilization (HRU) Results | Hospitalized per protocol | 11 Participants |
| Standard of Care Arm | Hospital Resource Utilization (HRU) Results | Hospitalized due to Adverse Event (AE) | 42 Participants |
| Standard of Care Arm | Hospital Resource Utilization (HRU) Results | Admitted to Intensive Care Unit (ICU) | 4 Participants |
| Standard of Care Arm | Hospital Resource Utilization (HRU) Results | Hospitalized | 74 Participants |
| Liso-cel Arm | Hospital Resource Utilization (HRU) Results | Admitted to Intensive Care Unit (ICU) | 5 Participants |
| Liso-cel Arm | Hospital Resource Utilization (HRU) Results | Hospitalized | 87 Participants |
| Liso-cel Arm | Hospital Resource Utilization (HRU) Results | Hospitalized due to Adverse Event (AE) | 44 Participants |
| Liso-cel Arm | Hospital Resource Utilization (HRU) Results | Hospitalized due to Progression of Disease | 6 Participants |
| Liso-cel Arm | Hospital Resource Utilization (HRU) Results | Hospitalized due to other reasons | 71 Participants |
| Liso-cel Arm | Hospital Resource Utilization (HRU) Results | Hospitalized per protocol | 22 Participants |
Secondary
Number of Participants With Complete Response (CR)
The number of participants achieving a best overall response of complete response (CR). Participants with unknown or missing response will be counted as non-evaluable in the analysis. CR: Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, no extralymphatic sites, no new lesions. Complete metabolic response: Lymph nodes/extralymphatic sites score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease.
Time frame: From randomization up to 3 years post randomization (Up to 36 months)
Population: All randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Number of Participants With Complete Response (CR) | 40 Participants |
| Liso-cel Arm | Number of Participants With Complete Response (CR) | 68 Participants |
Secondary
Number of Participants With Progression-free Survival on Next Line of Treatment (PFS-2)
Progression-free Survival (PFS)-2 based on investigator's assessment is defined as time from randomization to second objective progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.
Time frame: From randomization to second objective progression, or death from any cause, whichever occurs first (Up to 36 months)
Population: All randomized participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care Arm | Number of Participants With Progression-free Survival on Next Line of Treatment (PFS-2) | Number of patients who died | 15 Participants |
| Standard of Care Arm | Number of Participants With Progression-free Survival on Next Line of Treatment (PFS-2) | Number of patients with first progression | 60 Participants |
| Standard of Care Arm | Number of Participants With Progression-free Survival on Next Line of Treatment (PFS-2) | Number of patients with second progression | 8 Participants |
| Liso-cel Arm | Number of Participants With Progression-free Survival on Next Line of Treatment (PFS-2) | Number of patients who died | 10 Participants |
| Liso-cel Arm | Number of Participants With Progression-free Survival on Next Line of Treatment (PFS-2) | Number of patients with first progression | 40 Participants |
| Liso-cel Arm | Number of Participants With Progression-free Survival on Next Line of Treatment (PFS-2) | Number of patients with second progression | 8 Participants |
Secondary
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs)
A serious adverse event is defined as any adverse event occurring at any dose that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. Treatment emergent adverse events are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time frame: From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months)
Population: All participants treated in any study medication per overall participants and in clinical, histological and molecular subgroups that are prespecified for this endpoint (subgroups are not mutually exclusive)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | Overall Participants with serious TEAEs | 45 Participants |
| Standard of Care Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) with serious TEAEs | 29 Participants |
| Standard of Care Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | NIH: High-Grade B-cell Lymphoma with DLBCL Histology with serious TEAEs | 9 Participants |
| Standard of Care Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma with serious TEAEs | 4 Participants |
| Standard of Care Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma with serious TEAEs | 3 Participants |
| Standard of Care Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo with serious TEAEs | 25 Participants |
| Standard of Care Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | DLBCL: DLBCL from Transformed Indolent NHL with serious TEAEs | 4 Participants |
| Liso-cel Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | DLBCL: DLBCL from Transformed Indolent NHL with serious TEAEs | 3 Participants |
| Liso-cel Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma with serious TEAEs | 2 Participants |
| Liso-cel Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | Overall Participants with serious TEAEs | 43 Participants |
| Liso-cel Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo with serious TEAEs | 20 Participants |
| Liso-cel Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) with serious TEAEs | 23 Participants |
| Liso-cel Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | NIH: Follicular Lymphoma Grade 3B with serious TEAEs | 0 Participants |
| Liso-cel Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma with serious TEAEs | 1 Participants |
| Liso-cel Arm | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) | NIH: High-Grade B-cell Lymphoma with DLBCL Histology with serious TEAEs | 17 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. TEAEs are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time frame: From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months)
Population: All participants treated in any study medication per overall participants and in clinical, histological and molecular subgroups that are prespecified for this endpoint (subgroups are not mutually exclusive)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Overall participants with TEAEs | 90 Participants |
| Standard of Care Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) with TEAEs | 57 Participants |
| Standard of Care Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | NIH: High-Grade B-cell Lymphoma with DLBCL Histology with TEAEs | 20 Participants |
| Standard of Care Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma with TEAEs | 9 Participants |
| Standard of Care Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma with TEAEs | 4 Participants |
| Standard of Care Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo with TEAEs | 49 Participants |
| Standard of Care Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | DLBCL: DLBCL from Transformed Indolent NHL with TEAEs | 8 Participants |
| Liso-cel Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | DLBCL: DLBCL from Transformed Indolent NHL with TEAEs | 7 Participants |
| Liso-cel Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma with TEAEs | 8 Participants |
| Liso-cel Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Overall participants with TEAEs | 92 Participants |
| Liso-cel Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo with TEAEs | 53 Participants |
| Liso-cel Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) with TEAEs | 60 Participants |
| Liso-cel Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | NIH: Follicular Lymphoma Grade 3B with TEAEs | 1 Participants |
| Liso-cel Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma with TEAEs | 1 Participants |
| Liso-cel Arm | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | NIH: High-Grade B-cell Lymphoma with DLBCL Histology with TEAEs | 22 Participants |
Secondary
Overall Response Rate (ORR)
ORR is defined as the percentage of participants achieving a best overall response of partial response (PR) or complete response (CR). CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline.
Time frame: From randomization to PR or CR (Up to 36 months)
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care Arm | Overall Response Rate (ORR) | 48.9 Percentage of participants |
| Liso-cel Arm | Overall Response Rate (ORR) | 87.0 Percentage of participants |
Secondary
Overall Response Rate (ORR) by Subgroups
ORR is defined as the percentage of participants achieving a best overall response of partial response (PR) or complete response (CR). CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline.
Time frame: From randomization to PR or CR (Up to 36 months)
Population: All randomized participants per clinical, histological and molecular subgroups that are pre-specified for ORR (subgroups are not mutually exclusive and participants are not exclusive to one subgroup)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care Arm | Overall Response Rate (ORR) by Subgroups | DLBCL: DLBCL from Transformed Indolent NHL | 37.5 Percentage of participants |
| Standard of Care Arm | Overall Response Rate (ORR) by Subgroups | NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma | 75.0 Percentage of participants |
| Standard of Care Arm | Overall Response Rate (ORR) by Subgroups | DLBCL: Germinal Center B-cell like (GCB) | 50.0 Percentage of participants |
| Standard of Care Arm | Overall Response Rate (ORR) by Subgroups | NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma | 33.3 Percentage of participants |
| Standard of Care Arm | Overall Response Rate (ORR) by Subgroups | DLBCL: Activated B-cell-like, non-GCB | 44.8 Percentage of participants |
| Standard of Care Arm | Overall Response Rate (ORR) by Subgroups | Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo | 54.0 Percentage of participants |
| Standard of Care Arm | Overall Response Rate (ORR) by Subgroups | NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL) | 40.0 Percentage of participants |
| Standard of Care Arm | Overall Response Rate (ORR) by Subgroups | NIH: High-Grade B-cell Lymphoma with DLBCL Histology | 42.9 Percentage of participants |
| Standard of Care Arm | Overall Response Rate (ORR) by Subgroups | NHL: Non-DHL/THL | 51.4 Percentage of participants |
| Standard of Care Arm | Overall Response Rate (ORR) by Subgroups | Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) | 51.7 Percentage of participants |
| Liso-cel Arm | Overall Response Rate (ORR) by Subgroups | NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL) | 81.8 Percentage of participants |
| Liso-cel Arm | Overall Response Rate (ORR) by Subgroups | NHL: Non-DHL/THL | 88.6 Percentage of participants |
| Liso-cel Arm | Overall Response Rate (ORR) by Subgroups | Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) | 86.7 Percentage of participants |
| Liso-cel Arm | Overall Response Rate (ORR) by Subgroups | NIH: Follicular Lymphoma Grade 3B | 100 Percentage of participants |
| Liso-cel Arm | Overall Response Rate (ORR) by Subgroups | NIH: High-Grade B-cell Lymphoma with DLBCL Histology | 81.8 Percentage of participants |
| Liso-cel Arm | Overall Response Rate (ORR) by Subgroups | NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma | 100 Percentage of participants |
| Liso-cel Arm | Overall Response Rate (ORR) by Subgroups | NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma | 100 Percentage of participants |
| Liso-cel Arm | Overall Response Rate (ORR) by Subgroups | Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo | 86.8 Percentage of participants |
| Liso-cel Arm | Overall Response Rate (ORR) by Subgroups | DLBCL: DLBCL from Transformed Indolent NHL | 85.7 Percentage of participants |
| Liso-cel Arm | Overall Response Rate (ORR) by Subgroups | DLBCL: Germinal Center B-cell like (GCB) | 91.1 Percentage of participants |
| Liso-cel Arm | Overall Response Rate (ORR) by Subgroups | DLBCL: Activated B-cell-like, non-GCB | 85.7 Percentage of participants |
Secondary
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates.
Time frame: From randomization to time of death due to any cause (Up to 36 months)
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Arm | Overall Survival (OS) | NA Months |
| Liso-cel Arm | Overall Survival (OS) | NA Months |
Secondary
Overall Survival (OS) by Subgroups
Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates.
Time frame: From randomization to time of death due to any cause (Up to 36 months)
Population: All randomized participants per clinical, histological and molecular subgroups that are pre-specified for OS (subgroups are not mutually exclusive)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard of Care Arm | Overall Survival (OS) by Subgroups | Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo | NA Months |
| Standard of Care Arm | Overall Survival (OS) by Subgroups | NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma | NA Months |
| Standard of Care Arm | Overall Survival (OS) by Subgroups | DLBCL: DLBCL from Transformed Indolent NHL | 28.2 Months |
| Standard of Care Arm | Overall Survival (OS) by Subgroups | NIH: High-Grade B-cell Lymphoma with DLBCL Histology | 16.3 Months |
| Standard of Care Arm | Overall Survival (OS) by Subgroups | DLBCL: Germinal Center B-cell like (GCB) | NA Months |
| Standard of Care Arm | Overall Survival (OS) by Subgroups | NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma | NA Months |
| Standard of Care Arm | Overall Survival (OS) by Subgroups | DLBCL: Activated B-cell-like, non-GCB | 16.3 Months |
| Standard of Care Arm | Overall Survival (OS) by Subgroups | Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) | NA Months |
| Standard of Care Arm | Overall Survival (OS) by Subgroups | NHL: Non-DHL/THL | NA Months |
| Standard of Care Arm | Overall Survival (OS) by Subgroups | NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL) | 16.3 Months |
| Liso-cel Arm | Overall Survival (OS) by Subgroups | DLBCL: Activated B-cell-like, non-GCB | NA Months |
| Liso-cel Arm | Overall Survival (OS) by Subgroups | NHL: Non-DHL/THL | NA Months |
| Liso-cel Arm | Overall Survival (OS) by Subgroups | NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL) | 13.3 Months |
| Liso-cel Arm | Overall Survival (OS) by Subgroups | Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) | NA Months |
| Liso-cel Arm | Overall Survival (OS) by Subgroups | NIH: Follicular Lymphoma Grade 3B | NA Months |
| Liso-cel Arm | Overall Survival (OS) by Subgroups | NIH: High-Grade B-cell Lymphoma with DLBCL Histology | 13.3 Months |
| Liso-cel Arm | Overall Survival (OS) by Subgroups | NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma | NA Months |
| Liso-cel Arm | Overall Survival (OS) by Subgroups | NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma | NA Months |
| Liso-cel Arm | Overall Survival (OS) by Subgroups | Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo | NA Months |
| Liso-cel Arm | Overall Survival (OS) by Subgroups | DLBCL: DLBCL from Transformed Indolent NHL | NA Months |
| Liso-cel Arm | Overall Survival (OS) by Subgroups | DLBCL: Germinal Center B-cell like (GCB) | NA Months |
Secondary
Overall Survival (OS) Rate
Overall Survival (OS) rate is defined as the percentage of participants alive at fixed timepoints. OS is defined as the time from randomization to death due to any cause. Participants alive or lost to follow up at the time of analysis will be censored at the last date the participants was known to be alive.
Time frame: Months 6, 12, 18, 24, 36
Population: All randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care Arm | Overall Survival (OS) Rate | OS Rate at 18 months | 61.7 Percentage of participants |
| Standard of Care Arm | Overall Survival (OS) Rate | OS Rate at 36 months | 51.8 Percentage of participants |
| Standard of Care Arm | Overall Survival (OS) Rate | OS Rate at 12 months | 72.0 Percentage of participants |
| Standard of Care Arm | Overall Survival (OS) Rate | Participants who died | 45.7 Percentage of participants |
| Standard of Care Arm | Overall Survival (OS) Rate | OS Rate at 24 months | 58.2 Percentage of participants |
| Standard of Care Arm | Overall Survival (OS) Rate | Participants who were censored | 54.3 Percentage of participants |
| Standard of Care Arm | Overall Survival (OS) Rate | OS Rate at 6 months | 88.9 Percentage of participants |
| Liso-cel Arm | Overall Survival (OS) Rate | Participants who were censored | 63.0 Percentage of participants |
| Liso-cel Arm | Overall Survival (OS) Rate | OS Rate at 6 months | 93.4 Percentage of participants |
| Liso-cel Arm | Overall Survival (OS) Rate | OS Rate at 12 months | 83.5 Percentage of participants |
| Liso-cel Arm | Overall Survival (OS) Rate | OS Rate at 18 months | 73.3 Percentage of participants |
| Liso-cel Arm | Overall Survival (OS) Rate | OS Rate at 24 months | 67.5 Percentage of participants |
| Liso-cel Arm | Overall Survival (OS) Rate | OS Rate at 36 months | 62.8 Percentage of participants |
| Liso-cel Arm | Overall Survival (OS) Rate | Participants who died | 37.0 Percentage of participants |
Secondary
Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT)
Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT).
Time frame: Up to 5 months after first dose
Population: All treated participants in SOC arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care Arm | Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT) | 47.3 Percentage of participants |
Secondary
Percentage of Participants Completing High Dose Chemotherapy (HDCT)
Percentage of Participants Completing High Dose Chemotherapy (HDCT).
Time frame: Up to 5 months after first dose
Population: All treated participants in SOC arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care Arm | Percentage of Participants Completing High Dose Chemotherapy (HDCT) | 47.3 Percentage of participants |
Secondary
Progression-free Survival (PFS)
Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.
Time frame: From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months)
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Arm | Progression-free Survival (PFS) | 6.2 Months |
| Liso-cel Arm | Progression-free Survival (PFS) | NA Months |
Secondary
Progression-free Survival (PFS) by Subgroups
Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.
Time frame: From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months)
Population: All randomized participants per clinical, histological and molecular subgroups that are pre-specified for PFS (subgroups are not mutually exclusive)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard of Care Arm | Progression-free Survival (PFS) by Subgroups | DLBCL: DLBCL from Transformed Indolent NHL | 3.4 Months |
| Standard of Care Arm | Progression-free Survival (PFS) by Subgroups | NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma | NA Months |
| Standard of Care Arm | Progression-free Survival (PFS) by Subgroups | DLBCL: Germinal Center B-cell like (GCB) | 4.6 Months |
| Standard of Care Arm | Progression-free Survival (PFS) by Subgroups | NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma | NA Months |
| Standard of Care Arm | Progression-free Survival (PFS) by Subgroups | DLBCL: Activated B-cell-like, non-GCB | 7.5 Months |
| Standard of Care Arm | Progression-free Survival (PFS) by Subgroups | Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo | 6.4 Months |
| Standard of Care Arm | Progression-free Survival (PFS) by Subgroups | NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL) | 4.3 Months |
| Standard of Care Arm | Progression-free Survival (PFS) by Subgroups | NIH: High-Grade B-cell Lymphoma with DLBCL Histology | 4.3 Months |
| Standard of Care Arm | Progression-free Survival (PFS) by Subgroups | NHL: Non-DHL/THL | 6.4 Months |
| Standard of Care Arm | Progression-free Survival (PFS) by Subgroups | Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) | 6.0 Months |
| Liso-cel Arm | Progression-free Survival (PFS) by Subgroups | NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL) | 5.8 Months |
| Liso-cel Arm | Progression-free Survival (PFS) by Subgroups | NHL: Non-DHL/THL | NA Months |
| Liso-cel Arm | Progression-free Survival (PFS) by Subgroups | Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) | NA Months |
| Liso-cel Arm | Progression-free Survival (PFS) by Subgroups | NIH: Follicular Lymphoma Grade 3B | NA Months |
| Liso-cel Arm | Progression-free Survival (PFS) by Subgroups | NIH: High-Grade B-cell Lymphoma with DLBCL Histology | 5.8 Months |
| Liso-cel Arm | Progression-free Survival (PFS) by Subgroups | NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma | NA Months |
| Liso-cel Arm | Progression-free Survival (PFS) by Subgroups | NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma | NA Months |
| Liso-cel Arm | Progression-free Survival (PFS) by Subgroups | Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo | NA Months |
| Liso-cel Arm | Progression-free Survival (PFS) by Subgroups | DLBCL: DLBCL from Transformed Indolent NHL | NA Months |
| Liso-cel Arm | Progression-free Survival (PFS) by Subgroups | DLBCL: Germinal Center B-cell like (GCB) | 14.8 Months |
| Liso-cel Arm | Progression-free Survival (PFS) by Subgroups | DLBCL: Activated B-cell-like, non-GCB | 33.2 Months |
Secondary
Progression-free Survival (PFS) Rate
Progression-free Survival (PFS) rate is defined as the percentage of participants free of any PFS event at fixed timepoints. Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.
Time frame: Months 6, 12, 18, 24, 36
Population: All randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care Arm | Progression-free Survival (PFS) Rate | PFS Rate at 12 months | 31.3 Percentage of participants |
| Standard of Care Arm | Progression-free Survival (PFS) Rate | PFS Rate at 24 months | 29.7 Percentage of participants |
| Standard of Care Arm | Progression-free Survival (PFS) Rate | PFS Rate at 18 months | 31.3 Percentage of participants |
| Standard of Care Arm | Progression-free Survival (PFS) Rate | PFS Rate at 36 months | 26.5 Percentage of participants |
| Standard of Care Arm | Progression-free Survival (PFS) Rate | PFS Rate at 6 months | 51.7 Percentage of participants |
| Liso-cel Arm | Progression-free Survival (PFS) Rate | PFS Rate at 36 months | 50.9 Percentage of participants |
| Liso-cel Arm | Progression-free Survival (PFS) Rate | PFS Rate at 6 months | 73.7 Percentage of participants |
| Liso-cel Arm | Progression-free Survival (PFS) Rate | PFS Rate at 12 months | 63.0 Percentage of participants |
| Liso-cel Arm | Progression-free Survival (PFS) Rate | PFS Rate at 18 months | 58.2 Percentage of participants |
| Liso-cel Arm | Progression-free Survival (PFS) Rate | PFS Rate at 24 months | 57.0 Percentage of participants |