| Primary | Overall Response Rate (ORR) | Overall response rate is the percent of participants with a best overall response (BOR) of either complete response (CR) or partial reasons (PR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment. CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment. PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size. PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma. | All participants with PET positive disease who received at least one infusion of JCAR017 | Posted | | Number | 95% Confidence Interval | Percent of Participants | | From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months) | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Exact binomial test | | <.0001 | One sided P-value is calculated based on the null hypothesis ORR <= 50.2% | | | | | | | | | | | | | Superiority | | |
|
| Secondary | Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs) | A TEAE was defined as an adverse event that started any time from initiation of product administration through and including 90 days following product administration. AEs that occurred after the initiation of subsequent anticancer therapy or product retreatment were not considered as product TEAE. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe, Grade 4= Life-threatening, and 5 = Death. | All participants who received at least one JCAR017 infusion | Posted | | Count of Participants | | Participants | | From first dose to 90 days following first dose (up to approximately 90 days) | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Change From Baseline of Hematology Laboratory Results: Hemoglobin | Change from baseline in Hematology laboratory analysis. Includes Hemoglobin. Baseline is the last observation collected prior to or on the date of product infusion. | All participants who received at least one JCAR017 infusion evaluable for hematology laboratory tests | Posted | | Mean | Standard Deviation | g/L | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Change From Baseline of Hematology Laboratory Results: Leukocytes, Lymphocytes, Neutrophils, Platelets | Change from baseline in Hematology laboratory analysis. Includes Leukocytes, Lymphocytes, Neutrophils, and Platelets. Baseline is the last observation collected prior to or on the date of product infusion. | All participants who received at least one JCAR017 infusion evaluable for hematology laboratory tests | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Change From Baseline of Chemistry Laboratory Results: Albumin | Change from baseline in Chemistry laboratory analysis. Includes Albumin. Baseline is the last observation collected prior to or on the date of product infusion. | All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests | Posted | | Mean | Standard Deviation | g/L | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Change From Baseline of Chemistry Laboratory Results: Alanine Aminotransferase, Aspartate Aminotransferase, Lactate Dehydrogenase | Change from baseline in Chemistry laboratory analysis. Includes Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase. Baseline is the last observation collected prior to or on the date of product infusion. | All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests | Posted | | Mean | Standard Deviation | U/L | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Change From Baseline of Chemistry Laboratory Results: Bilirubin, Creatinine, Direct Bilirubin, Urate | Change from baseline in Chemistry laboratory analysis. Includes Bilirubin, Creatinine, Direct Bilirubin, and Urate. Baseline is the last observation collected prior to or on the date of product infusion. | All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests | Posted | | Mean | Standard Deviation | umol/L | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Change From Baseline of Chemistry Laboratory Results: Calcium Corrected, Magnesium, Phosphate, Potassium, Sodium | Change from baseline in Chemistry laboratory analysis. Includes Calcium Corrected, Magnesium, Phosphate, Potassium, and Sodium. Baseline is the last observation collected prior to or on the date of product infusion. | All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Complete Response (CR) Rate | Complete response rate (CRR) was defined as the percent of participants with a best overall response (BOR) of complete response (CR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment. CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment. PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma. | All participants with PET positive disease who received at least one infusion of JCAR017 | Posted | | Number | 95% Confidence Interval | Percent of Participants | | From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplant (up to approximately 24 months) | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Duration of Response (DOR) | Duration of response (DOR) is defined as the time from first complete response(CR) or partial response (PR) to progressive disease (PD) or death, whichever occurred first. CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment. PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size. PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma. | All participants with PET positive disease who received at least one infusion of JCAR017 and achieved a response (CR or PR) | Posted | | Median | 95% Confidence Interval | Months | | From first dose to up to approximately 24 months | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Duration of Response (DOR) in Participants With Complete Response (CR) | DOR for participants with a best overall response of CR was defined as the time from documentation of first response (or CR) to progressive disease (PD) or death, whichever occurred first. The first documentation of CR/PR is the latest of all dates of required measurements to establish the response. The progression date is the earliest date of all assessments that led to a response assessment of PD. CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment. PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma. | All participants with PET positive disease who received at least one infusion of JCAR017 and achieved complete response (CR) | Posted | | Median | 95% Confidence Interval | Months | | From first dose to up to approximately 24 months | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
|
| Secondary | Progression-Free Survival (PFS) | PFS is defined as the time from JCAR017 infusion to progressive disease (PD) or death. Kaplan-Meier (KM) methodology will be used to analyze PFS. PD = Score 4 or 5b on the positron emission tomography 5-point scale (PET 5PS) with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma. | All participants with PET positive disease who received at least one infusion of JCAR017 | Posted | | Median | 95% Confidence Interval | Months | | From first dose to progressive disease (PD) or death (up to approximately 24 months) | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Event-Free Survival (EFS) | EFS is defined as the time from JCAR017 infusion to the earliest of the following events: death from any cause, progressive disease (PD), or starting a new anticancer therapy. Kaplan-Meier (KM) methodology will be used to analyze EFS. PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma. | All participants with PET positive disease who received at least one infusion of JCAR017 | Posted | | Median | 95% Confidence Interval | Months | | From first dose to death from any cause, progressive disease (PD), or starting a new anticancer therapy (up to approximately 24 months) | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Overall Survival (OS) | OS is defined as the time from JCAR017 infusion to the date of death. Kaplan-Meier (KM) methodology will be used to analyze OS. | All participants with PET positive disease who received at least one infusion of JCAR017 | Posted | | Median | 95% Confidence Interval | Months | | From first dose to date of death (up to approximately 24 months) | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | PK Parameters of JCAR017 in Blood as Assessed by qPCR: Cmax | Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). Cmax = Maximum observed blood concentration. | All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR | Posted | | Geometric Mean | Geometric Coefficient of Variation | copies/μg | | From first dose to up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | PK Parameters of JCAR017 in Blood as Assessed by qPCR: Tmax | Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). Tmax = Time of maximum observed blood concentration. | All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR | Posted | | Median | Full Range | Day | | From first dose to up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | PK Parameters of JCAR017 in Blood as Assessed by qPCR: AUC (0-28) | Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). AUC (0-28) = Area under the curve for concentration. | All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR | Posted | | Geometric Mean | Geometric Coefficient of Variation | day*copies/ug | | From first dose to up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
- Symptom scale/item higher score represents a high level of symptomatic problem.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health/QoL Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
- Symptom scale/item higher score represents a high level of symptomatic problem.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea/Vomiting Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
- Symptom scale/item higher score represents a high level of symptomatic problem.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
- Symptom scale/item higher score represents a high level of symptomatic problem.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
- Symptom scale/item higher score represents a high level of symptomatic problem.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
- Symptom scale/item higher score represents a high level of symptomatic problem.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
- Symptom scale/item higher score represents a high level of symptomatic problem.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
- Symptom scale/item higher score represents a high level of symptomatic problem.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties Subscale |
- Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
- The EORTC QLQ-C30 is a 30-item scale 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.
| All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Health-Related Quality of Life (HRQoL) Assessed by the FACT-Lym Subscale | The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. 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. | All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Health-Related Quality of Life (HRQoL) Assessed by the EuroQol Instrument EQ-5D-5L | The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-5L health states ranged from -.594 for the worst (55555) to 1 for the best (11111) for UK value set with an optimal health state is assigned a score of 1.00, death is assigned a score of 0.00 and negative values representing values as worse than dead. A change of .08 is considered to be a clinically meaningful change in health utility. | All participants who received at least one JCAR017 infusion who completed 5-dimension measures at baseline and at least one post-baseline | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
|
| Secondary | Numbers of Intensive Care Unit (ICU) Inpatient Days | The numbers of ICU inpatient days. | All participants who received at least one infusion of JCAR017 who were monitored inpatient | Posted | | Median | Full Range | Day | | From first dose after JCAR017 infusion to up to approximately 24 months | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | Numbers of Non-intensive Care Unit (ICU) Inpatient Days | Number of non-ICU inpatient days. | All participants who received at least one infusion of JCAR017 who were monitored inpatient | Posted | | Median | Full Range | Day | | From first dose after JCAR017 infusion to up to approximately 24 months | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |
| Secondary | The Number of Participants That Were Hospitalized For Adverse Events, Prophylaxis, Other | Length of hospitalization stay was reported for up to 24 months post liso-cel infusion. Reasons for hospitalization include adverse events, prophylaxis, and other. Adverse events were reported for up to 90 days post liso-cel infusion. | All participants who received at least one infusion of JCAR017 who were monitored inpatient | Posted | | Number | | Participants | | From first dose after JCAR017 infusion to up to approximately 24 months | | | | ID | Title | Description |
|---|
| OG000 | Lisocabtagene Maraleucel (JCAR017) | Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
| |