Refractory Large B-cell Lymphoma
Conditions
Brief summary
The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.
Detailed description
Following at least 24 months of assessments after axicabtagene ciloleucel infusion, participants will be asked to rollover to a separate long-term follow-up study (Study KT-US-982-5968). Participants will complete the remainder of the 15-year follow-up assessments in the KT-US-982-5968 study.
Interventions
BIOLOGICALAxicabtagene Ciloleucel
A single infusion of CAR-transduced autologous T cells administered intravenously
DRUGRituximab
Administered intravenously
DRUGFludarabine
Administered according to package insert
DRUGCyclophosphamide
Administered according to package insert
Sponsors
Kite, A Gilead Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Histologically confirmed large B-cell lymphoma * Chemotherapy-refractory disease, defined as one or more of the following: * No response to first-line therapy (primary refractory disease) * No response to second or greater lines of therapy OR * Refractory after autologous stem cell transplant (ASCT) * At least 1 measureable lesion according to the Lugano Classification (Cheson 2014). * Individuals must have received adequate prior therapy, including at a minimum: * Anti-CD20 monoclonal antibody * An anthracycline-containing chemotherapy regimen * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate renal, hepatic, pulmonary, and cardiac function Key
Exclusion criteria
* Known CD19 negative or CD20 negative tumor * History of Richter's transformation of Chronic Lymphocytic Leukemia (CLL) * Prior CAR therapy or other genetically modified T-cell therapy * Prior organ transplantation including prior allogeneic stem cell transplant (SCT) * Prior CD19 targeted therapy * Clinically significant infection or cardiopulmonary disease * Presence of any in-dwelling lines or drains (dedicated central venous access catheters allowed) * History or presence of central nervous system (CNS) lymphoma or nonmalignant CNS disorder or cerebrospinal fluid (CSF) malignant cells or brain metastases * History of autoimmune disease * History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last 6 months Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators | First infusion date up to maximum duration of 32.7 months | CR rate is defined as the incidence of a CR per the IWG Lugano Classification as determined by study investigators. CR rate: percentage of participants with CR \[complete metabolic response (CMR); complete radiological response (CRR)\]. CMR: positron emission tomography (PET) 5-point scale (5-PS) scores of 1 (no uptake above background), 2 (uptake ≤ mediastinum), 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass); no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow (BM). CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in longest transverse diameter of lesion (LDi); no extralymphatic sites of disease; absent non-measured lesion (NMLs); organ enlargement regress to normal; no new sites; and bone marrow normal by morphology. 95% confidence interval (CI) was calculated by Clopper-Pearson method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value | First infusion date up to maximum duration of 27 months | Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory parameters with only non-zero values are presented. |
| Objective Response Rate (ORR) Per the IWG Lugano Classification as Determined by Study Investigators | First infusion date up to maximum duration of 32.7 months | ORR: percentage of participants with CR \[CMR;CRR\] or PR \[partial metabolic response (PMR); partial radiologic response (PRR)\].CMR: PET 5PS scores of 1 (no uptake above background, 2 (uptake ≤ mediastinum), 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass; no new lesions; no evidence of FDG-avid disease in BM. CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in LDi;no extralymphatic sites of disease;absent NMLs;organ enlargement regress to normal;no new sites;bone marrow morphology normal. PMR: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at end of treatment (EOT). PRR: ≥ 50% decrease in sum of the product of perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absent/normal, regressed, but no increase of NMLs; spleen regressed by \> 50% in length beyond normal; no new sites. |
| Duration of Response (DOR) Per the IWG Lugano Classification as Determined by Study Investigators | From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (up to approximately 32.7 months) | DOR is defined only for participants who experience an objective response and is the time from the first objective response to disease progression \[progressive metabolic disease (PMD); progressive radiologic disease (PRD)\] or death from any cause. Objective response is defined in outcome measure (OM) 4. PMD: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with increased uptake compared with baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi \>1.5 cm; ≥ 50% increase from cross product of LDi and perpendicular diameter (PPD); increase in LDi or shortest axis perpendicular to the LDi (SDi) of 0.5 cm for lesions ≤1.5 cm and 1 cm for lesions \>2 cm; spleen increased by \>50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. Kaplan-Meier (KM) estimate of median was reported. |
| Progression-Free Survival (PFS) Per the IWG Lugano Classification as Determined by Study Investigators | First infusion date up to disease progression or death regardless of cause (up to approximately 32.7 months) | PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression (PMD; PRD) or death from any cause. PMD: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with increased uptake compared with baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi \>1.5 cm; ≥ 50% increase from cross product of LDi and PPD; increase in LDi or SDi of 0.5 cm for lesions ≤1.5 cm and 1 cm for lesions \>2 cm; spleen increased by \>50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. KM estimate of median was reported. |
| Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | First infusion date up to maximum duration of 27 months | An AE is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a relationship with study treatment or worsening of a pre-existing medical condition. TEAEs are any AEs with onset on or after axicabtagene ciloleucel infusion or worsening of a pre-existing medical condition that occurs on or after axicabtagene ciloleucel infusion. |
| Peak Level of Anti-CD19 CAR T Cells in Blood | Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24 | Peak was defined as the maximum number of CAR T cells in blood measured after infusion. |
| Level of Anti-CD19 CAR T Cells in Blood by Visit | Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24 | — |
| Area Under the Curve of CAR T Cells From Day 0 to Day 28 (AUC0-28) | Baseline (Day 0), post-infusion on Days 7, 14, 21, and 28 | AUC0-28 is defined as the area under curve in a plot of number of CAR T cells against scheduled visit from Day 0 to Day 28. |
| Time to Peak Level of Anti-CD19 CAR T Cells in Blood | Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24 | Time to peak was defined as the number of days from the date of the axicabtagene ciloleucel infusion to the date of peak level defined as the maximum number of CAR T cells in blood measured after infusion. |
| Overall Survival (OS) | First infusion date up to death regardless of cause (up to approximately 32.7 months) | OS is defined as the time from axicabtagene ciloleucel infusion to the date of death from any cause. KM estimate of median was reported. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States.
Pre-assignment details
36 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Axicabtagene Ciloleucel and Rituximab Combination Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 10 |
| Overall Study | Enrolled but Never Treated | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Rolled Over to Long-term Follow-up Study | 13 |
| Overall Study | Subject Withdrawal of Consent From Further Follow-up | 2 |
Baseline characteristics
| Characteristic | Axicabtagene Ciloleucel and Rituximab Combination |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants |
| Race/Ethnicity, Customized Race Other or More Than One Race | 4 Participants |
| Race/Ethnicity, Customized Race White | 19 Participants |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 27 |
| other Total, other adverse events | 26 / 26 |
| serious Total, serious adverse events | 14 / 26 |
Outcome results
Primary
Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators
CR rate is defined as the incidence of a CR per the IWG Lugano Classification as determined by study investigators. CR rate: percentage of participants with CR \[complete metabolic response (CMR); complete radiological response (CRR)\]. CMR: positron emission tomography (PET) 5-point scale (5-PS) scores of 1 (no uptake above background), 2 (uptake ≤ mediastinum), 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass); no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow (BM). CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in longest transverse diameter of lesion (LDi); no extralymphatic sites of disease; absent non-measured lesion (NMLs); organ enlargement regress to normal; no new sites; and bone marrow normal by morphology. 95% confidence interval (CI) was calculated by Clopper-Pearson method.
Time frame: First infusion date up to maximum duration of 32.7 months
Population: Modified intent-to-treat (mITT) analysis set included all enrolled participants who were treated with the target dose of axicabtagene ciloleucel and at least 1 dose of rituximab after axicabtagene ciloleucel infusion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axicabtagene Ciloleucel and Rituximab Combination | Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators | 73 percentage of participants |
Secondary
Area Under the Curve of CAR T Cells From Day 0 to Day 28 (AUC0-28)
AUC0-28 is defined as the area under curve in a plot of number of CAR T cells against scheduled visit from Day 0 to Day 28.
Time frame: Baseline (Day 0), post-infusion on Days 7, 14, 21, and 28
Population: Participants in the safety analysis set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axicabtagene Ciloleucel and Rituximab Combination | Area Under the Curve of CAR T Cells From Day 0 to Day 28 (AUC0-28) | 376.83 cells/μL*days |
Secondary
Duration of Response (DOR) Per the IWG Lugano Classification as Determined by Study Investigators
DOR is defined only for participants who experience an objective response and is the time from the first objective response to disease progression \[progressive metabolic disease (PMD); progressive radiologic disease (PRD)\] or death from any cause. Objective response is defined in outcome measure (OM) 4. PMD: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with increased uptake compared with baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi \>1.5 cm; ≥ 50% increase from cross product of LDi and perpendicular diameter (PPD); increase in LDi or shortest axis perpendicular to the LDi (SDi) of 0.5 cm for lesions ≤1.5 cm and 1 cm for lesions \>2 cm; spleen increased by \>50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. Kaplan-Meier (KM) estimate of median was reported.
Time frame: From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (up to approximately 32.7 months)
Population: Participants in the mITT analysis set with an objective response (CR+PR) were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axicabtagene Ciloleucel and Rituximab Combination | Duration of Response (DOR) Per the IWG Lugano Classification as Determined by Study Investigators | 26.0 months |
Secondary
Level of Anti-CD19 CAR T Cells in Blood by Visit
Time frame: Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24
Population: Participants in the safety analysis set with available data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Axicabtagene Ciloleucel and Rituximab Combination | Level of Anti-CD19 CAR T Cells in Blood by Visit | Baseline (Day 0) | 0.00 cells/µL |
| Axicabtagene Ciloleucel and Rituximab Combination | Level of Anti-CD19 CAR T Cells in Blood by Visit | Day 7 Post-infusion | 18.11 cells/µL |
| Axicabtagene Ciloleucel and Rituximab Combination | Level of Anti-CD19 CAR T Cells in Blood by Visit | Day 14 Post-infusion | 12.74 cells/µL |
| Axicabtagene Ciloleucel and Rituximab Combination | Level of Anti-CD19 CAR T Cells in Blood by Visit | Day 21 Post-infusion | 4.66 cells/µL |
| Axicabtagene Ciloleucel and Rituximab Combination | Level of Anti-CD19 CAR T Cells in Blood by Visit | Day 28 Post-infusion | 1.66 cells/µL |
| Axicabtagene Ciloleucel and Rituximab Combination | Level of Anti-CD19 CAR T Cells in Blood by Visit | Day 49 Post-infusion | 0.99 cells/µL |
| Axicabtagene Ciloleucel and Rituximab Combination | Level of Anti-CD19 CAR T Cells in Blood by Visit | Day 105 Post-infusion | 0.32 cells/µL |
| Axicabtagene Ciloleucel and Rituximab Combination | Level of Anti-CD19 CAR T Cells in Blood by Visit | Day 180 Post-infusion | 0.09 cells/µL |
| Axicabtagene Ciloleucel and Rituximab Combination | Level of Anti-CD19 CAR T Cells in Blood by Visit | Month 9 Post-infusion | 0.06 cells/µL |
| Axicabtagene Ciloleucel and Rituximab Combination | Level of Anti-CD19 CAR T Cells in Blood by Visit | Month 12 Post-infusion | 0.0054 cells/µL |
| Axicabtagene Ciloleucel and Rituximab Combination | Level of Anti-CD19 CAR T Cells in Blood by Visit | Month 15 Post-infusion | 0.0027 cells/µL |
| Axicabtagene Ciloleucel and Rituximab Combination | Level of Anti-CD19 CAR T Cells in Blood by Visit | Month 18 Post-infusion | 0.00 cells/µL |
| Axicabtagene Ciloleucel and Rituximab Combination | Level of Anti-CD19 CAR T Cells in Blood by Visit | Month 24 Post-infusion | 0.00 cells/µL |
Secondary
Objective Response Rate (ORR) Per the IWG Lugano Classification as Determined by Study Investigators
ORR: percentage of participants with CR \[CMR;CRR\] or PR \[partial metabolic response (PMR); partial radiologic response (PRR)\].CMR: PET 5PS scores of 1 (no uptake above background, 2 (uptake ≤ mediastinum), 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass; no new lesions; no evidence of FDG-avid disease in BM. CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in LDi;no extralymphatic sites of disease;absent NMLs;organ enlargement regress to normal;no new sites;bone marrow morphology normal. PMR: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at end of treatment (EOT). PRR: ≥ 50% decrease in sum of the product of perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absent/normal, regressed, but no increase of NMLs; spleen regressed by \> 50% in length beyond normal; no new sites.
Time frame: First infusion date up to maximum duration of 32.7 months
Population: Participants in the mITT analysis set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axicabtagene Ciloleucel and Rituximab Combination | Objective Response Rate (ORR) Per the IWG Lugano Classification as Determined by Study Investigators | 88 percentage of participants |
Secondary
Overall Survival (OS)
OS is defined as the time from axicabtagene ciloleucel infusion to the date of death from any cause. KM estimate of median was reported.
Time frame: First infusion date up to death regardless of cause (up to approximately 32.7 months)
Population: Participants in the mITT analysis set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axicabtagene Ciloleucel and Rituximab Combination | Overall Survival (OS) | NA months |
Secondary
Peak Level of Anti-CD19 CAR T Cells in Blood
Peak was defined as the maximum number of CAR T cells in blood measured after infusion.
Time frame: Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24
Population: Participants in the safety analysis set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axicabtagene Ciloleucel and Rituximab Combination | Peak Level of Anti-CD19 CAR T Cells in Blood | 40.33 cells per microliter (cells/µL) |
Secondary
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value
Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory parameters with only non-zero values are presented.
Time frame: First infusion date up to maximum duration of 27 months
Population: Participants in the safety analysis set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Axicabtagene Ciloleucel and Rituximab Combination | Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value | Alanine Aminotransferase | 12 percentage of participants |
| Axicabtagene Ciloleucel and Rituximab Combination | Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value | Aspartate Aminotransferase | 12 percentage of participants |
| Axicabtagene Ciloleucel and Rituximab Combination | Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value | Bilirubin | 8 percentage of participants |
| Axicabtagene Ciloleucel and Rituximab Combination | Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value | Calcium | 8 percentage of participants |
| Axicabtagene Ciloleucel and Rituximab Combination | Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value | Direct Bilirubin | 15 percentage of participants |
| Axicabtagene Ciloleucel and Rituximab Combination | Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value | Glucose | 19 percentage of participants |
| Axicabtagene Ciloleucel and Rituximab Combination | Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value | Magnesium | 8 percentage of participants |
| Axicabtagene Ciloleucel and Rituximab Combination | Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value | Urate | 8 percentage of participants |
Secondary
Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)
An AE is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a relationship with study treatment or worsening of a pre-existing medical condition. TEAEs are any AEs with onset on or after axicabtagene ciloleucel infusion or worsening of a pre-existing medical condition that occurs on or after axicabtagene ciloleucel infusion.
Time frame: First infusion date up to maximum duration of 27 months
Population: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axicabtagene Ciloleucel and Rituximab Combination | Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | 100 percentage of participants |
Secondary
Progression-Free Survival (PFS) Per the IWG Lugano Classification as Determined by Study Investigators
PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression (PMD; PRD) or death from any cause. PMD: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with increased uptake compared with baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi \>1.5 cm; ≥ 50% increase from cross product of LDi and PPD; increase in LDi or SDi of 0.5 cm for lesions ≤1.5 cm and 1 cm for lesions \>2 cm; spleen increased by \>50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. KM estimate of median was reported.
Time frame: First infusion date up to disease progression or death regardless of cause (up to approximately 32.7 months)
Population: Participants in the mITT analysis set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axicabtagene Ciloleucel and Rituximab Combination | Progression-Free Survival (PFS) Per the IWG Lugano Classification as Determined by Study Investigators | 23.6 months |
Secondary
Time to Peak Level of Anti-CD19 CAR T Cells in Blood
Time to peak was defined as the number of days from the date of the axicabtagene ciloleucel infusion to the date of peak level defined as the maximum number of CAR T cells in blood measured after infusion.
Time frame: Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24
Population: Participants in the safety analysis set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axicabtagene Ciloleucel and Rituximab Combination | Time to Peak Level of Anti-CD19 CAR T Cells in Blood | 8 days |