| 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. | All randomized participants | Posted | | Median | 95% Confidence Interval | Months | | 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) | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0002.4(2.2 to 4.9)
- OG00129.5(9.5 to NA)Upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.
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|
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| 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. | All randomized participants | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From randomization up to 3 years post randomization (Up to 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| 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. | All randomized participants | Posted | | Count of Participants | | Participants | | From randomization up to 3 years post randomization (Up to 36 months) | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| 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. | All randomized participants | Posted | | Median | 95% Confidence Interval | Months | | From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months) | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| 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. | All randomized participants | Posted | | Median | 95% Confidence Interval | Months | | From randomization to time of death due to any cause (Up to 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
| |
| 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. | All randomized participants | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From randomization to PR or CR (Up to 36 months) | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| 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. | All randomized participants with PR or CR | Posted | | Median | 95% Confidence Interval | Months | | From randomization to to disease progression, start of new antineoplastic therapy due to efficacy concerns or death, whichever occurs first (Up to 36 months) | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 |
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| 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. | All randomized participants | Posted | | Count of Participants | | Participants | | From randomization to second objective progression, or death from any cause, whichever occurs first (Up to 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| 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. | All randomized participants | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Months 6, 12, 18, 24, 36 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | Liso-cel Arm |
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| 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. | All randomized participants | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Months 6, 12, 18, 24, 36 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| 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. | All randomized participants | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Months 6, 12, 18, 24, 36 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| 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. | 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) | Posted | | Count of Participants | | Participants | | From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months) | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | |
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| 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. | 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) | Posted | | Count of Participants | | Participants | | From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months) | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 |
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| 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). | All treated participants with a baseline value and a post-baseline value at the time point | Posted | | Mean | Standard Deviation | g/L | | baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36 | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| 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). | All treated participants with a baseline value and a post-baseline value at the time point | Posted | | Mean | Standard Deviation | 10^9 cells/L | | baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36 | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| 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). | All treated participants with a baseline value and a post-baseline value at the time point | Posted | | Mean | Standard Deviation | U/L | | baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36 | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| 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). | All treated participants with a baseline value and a post-baseline value at the time point | Posted | | Mean | Standard Deviation | mmol/L | | baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36 | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| 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. | 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) | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From randomization to PR or CR (Up to 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | Liso-cel Arm | |
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| 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. | All randomized participants per clinical, histological and molecular subgroups that are pre-specified for EFS (subgroups are not mutually exclusive) | Posted | | Median | 95% Confidence Interval | Months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 |
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| 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. | All randomized participants per clinical, histological and molecular subgroups that are pre-specified for PFS (subgroups are not mutually exclusive) | Posted | | Median | 95% Confidence Interval | Months | | From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months) | | | | ID | Title | Description |
|---|
| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| 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. | All randomized participants per clinical, histological and molecular subgroups that are pre-specified for OS (subgroups are not mutually exclusive) | Posted | | Median | 95% Confidence Interval | Months | | From randomization to time of death due to any cause (Up to 36 months) | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| 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). | All treated participants with a health-related quality of life baseline assessment value and a post-baseline value at the time point | Posted | | Mean | Standard Deviation | score on a scale | | baseline, months 1, 6, 9, 12, 18, 24, 36 | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 |
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| 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. | All treated participants with a health-related quality of life baseline assessment value and a post-baseline value at the time point | Posted | | Mean | Standard Deviation | score on a scale | | baseline, months 1, 6, 9, 12, 18, 24, 36 | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | Liso-cel Arm |
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| Secondary | Hospital Resource Utilization (HRU) Results | Hospital resource utilization (HRU) results including hospitalized, reasons for hospitalizations, and admitted to intensive care unit (ICU) | All participants treated in any study medication | Posted | | Count of Participants | | Participants | | Up to 36 months | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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| Secondary | Percentage of Participants Completing High Dose Chemotherapy (HDCT) | Percentage of Participants Completing High Dose Chemotherapy (HDCT). | All treated participants in SOC arm | Posted | | Number | | Percentage of participants | | Up to 5 months after first dose | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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) |
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| Secondary | Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT) | Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT). | All treated participants in SOC arm | Posted | | Number | | Percentage of participants | | Up to 5 months after first dose | | | | ID | Title | Description |
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| OG000 | Standard of Care Arm | 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and 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 | | OG001 | 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) |
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