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Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483103
Recruitment Status : Completed
First Posted : March 30, 2018
Results First Posted : December 29, 2022
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
Juno Therapeutics, a Subsidiary of Celgene

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma, Non-Hodgkin
Lymphoma, Nonhodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Intervention Biological: lisocabtagene maraleucel
Enrollment 74
Recruitment Details  
Pre-assignment Details All efficacy and safety analyses were conducted on the JCAR017-treated Analysis Set.
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description 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.
Period Title: Pre-Treatment Phase
Started [1] 74
Completed [2] 63
Not Completed 11
Reason Not Completed
Other reasons             1
No longer meets eligibility criteria             4
Disease-related complications             1
Death             5
[1]
Participants who underwent leukapheresis
[2]
Participants who completed leukapheresis and continued to lymphodepleting chemotherapy (LDC) treatment period
Period Title: Treatment Phase
Started [1] 63
Received JCAR017 61
Received Nonconforming Product 1
Did Not Receive Either JAR017 or Nonconforming Product 1
Completed [2] 7
Not Completed 56
Reason Not Completed
Withdrawal by Subject             6
Other reasons             2
Death             20
Ongoing in study             26
Did not receive either JAR017 or nonconforming product             1
Received nonconforming product             1
[1]
Participants who underwent lymphodepleting chemotherapy (LDC) treatment
[2]
Completed study
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 74
Hide Baseline Analysis Population Description
74 participants were leukapheresed.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants
72.8  (6.57)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
< 65 years
8
  10.8%
>= 65 to < 70 years
7
   9.5%
>= 70 to < 75 years
27
  36.5%
>= 75 years
32
  43.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
Female
29
  39.2%
Male
45
  60.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
Hispanic or Latino
1
   1.4%
Not Hispanic or Latino
64
  86.5%
Unknown or Not Reported
9
  12.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   2.7%
White
64
  86.5%
More than one race
0
   0.0%
Unknown or Not Reported
6
   8.1%
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description

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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PET positive disease who received at least one infusion of JCAR017
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of Participants
80.3
(68.2 to 89.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisocabtagene Maraleucel (JCAR017)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments One sided P-value is calculated based on the null hypothesis ORR <= 50.2%
Method Exact binomial test
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame From first dose to 90 days following first dose (up to approximately 90 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with any TEAE
59
  96.7%
Participants with any serious TEAEs
20
  32.8%
Participants with any Grade ≥ 3 TEAEs
48
  78.7%
Participants with any product-related TEAE
48
  78.7%
3.Secondary Outcome
Title Change From Baseline of Hematology Laboratory Results: Hemoglobin
Hide Description Change from baseline in Hematology laboratory analysis. Includes Hemoglobin. Baseline is the last observation collected prior to or on the date of product infusion.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion evaluable for hematology laboratory tests
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: g/L
1.9  (10.05)
4.Secondary Outcome
Title Change From Baseline of Hematology Laboratory Results: Leukocytes, Lymphocytes, Neutrophils, Platelets
Hide Description 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion evaluable for hematology laboratory tests
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Leukocytes 0.921  (3.8562)
Lymphocytes 0.537  (0.5953)
Neutrophils -0.216  (3.4010)
Platelets -61.6  (96.55)
5.Secondary Outcome
Title Change From Baseline of Chemistry Laboratory Results: Albumin
Hide Description Change from baseline in Chemistry laboratory analysis. Includes Albumin. Baseline is the last observation collected prior to or on the date of product infusion.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: g/L
3.05  (3.866)
6.Secondary Outcome
Title Change From Baseline of Chemistry Laboratory Results: Alanine Aminotransferase, Aspartate Aminotransferase, Lactate Dehydrogenase
Hide Description 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: U/L
Alanine Aminotransferase 4.6  (16.42)
Aspartate Aminotransferase -3.9  (21.22)
Lactate Dehydrogenase -138.2  (339.82)
7.Secondary Outcome
Title Change From Baseline of Chemistry Laboratory Results: Bilirubin, Creatinine, Direct Bilirubin, Urate
Hide Description 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: umol/L
Bilirubin Number Analyzed 59 participants
-0.1741  (6.36075)
Creatinine Number Analyzed 59 participants
5.8734  (21.32985)
Direct Bilirubin Number Analyzed 55 participants
0.0306  (2.35650)
Urate Number Analyzed 56 participants
5.7897  (93.90174)
8.Secondary Outcome
Title Change From Baseline of Chemistry Laboratory Results: Calcium Corrected, Magnesium, Phosphate, Potassium, Sodium
Hide Description 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: mmol/L
Calcium Corrected Number Analyzed 59 participants
-0.0261  (0.12183)
Magnesium Number Analyzed 57 participants
-0.0209  (0.09292)
Phosphate Number Analyzed 58 participants
0.0479  (0.22624)
Potassium Number Analyzed 59 participants
-0.05  (0.426)
Sodium Number Analyzed 59 participants
1.0  (3.37)
9.Secondary Outcome
Title Complete Response (CR) Rate
Hide Description

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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PET positive disease who received at least one infusion of JCAR017
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of Participants
54.1
(40.8 to 66.9)
10.Secondary Outcome
Title Duration of Response (DOR)
Hide Description

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.
Time Frame From first dose to up to approximately 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PET positive disease who received at least one infusion of JCAR017 and achieved a response (CR or PR)
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 49
Median (95% Confidence Interval)
Unit of Measure: Months
12.09 [1] 
(6.24 to NA)
[1]
Insufficient number of participants with events.
11.Secondary Outcome
Title Duration of Response (DOR) in Participants With Complete Response (CR)
Hide Description

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.
Time Frame From first dose to up to approximately 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PET positive disease who received at least one infusion of JCAR017 and achieved complete response (CR)
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 33
Median (95% Confidence Interval)
Unit of Measure: Months
21.65 [1] 
(12.09 to NA)
[1]
Insufficient number of participants with events.
12.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description

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.
Time Frame From first dose to progressive disease (PD) or death (up to approximately 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PET positive disease who received at least one infusion of JCAR017
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 61
Median (95% Confidence Interval)
Unit of Measure: Months
9.03 [1] 
(4.17 to NA)
[1]
Insufficient number of participants with events.
13.Secondary Outcome
Title Event-Free Survival (EFS)
Hide Description

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.
Time Frame From first dose to death from any cause, progressive disease (PD), or starting a new anticancer therapy (up to approximately 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PET positive disease who received at least one infusion of JCAR017
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 61
Median (95% Confidence Interval)
Unit of Measure: Months
7.23
(3.22 to 22.60)
14.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from JCAR017 infusion to the date of death. Kaplan-Meier (KM) methodology will be used to analyze OS.
Time Frame From first dose to date of death (up to approximately 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with PET positive disease who received at least one infusion of JCAR017
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 61
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(17.28 to NA)
[1]
Insufficient number of participants with events.
15.Secondary Outcome
Title PK Parameters of JCAR017 in Blood as Assessed by qPCR: Cmax
Hide Description

Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR).

Cmax = Maximum observed blood concentration.
Time Frame From first dose to up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 55
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: copies/μg
22516.3
(237.4%)
16.Secondary Outcome
Title PK Parameters of JCAR017 in Blood as Assessed by qPCR: Tmax
Hide Description Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). Tmax = Time of maximum observed blood concentration.
Time Frame From first dose to up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 55
Median (Full Range)
Unit of Measure: Day
10.0
(6 to 22)
17.Secondary Outcome
Title PK Parameters of JCAR017 in Blood as Assessed by qPCR: AUC (0-28)
Hide Description Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). AUC (0-28) = Area under the curve for concentration.
Time Frame From first dose to up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 55
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: day*copies/ug
178631.0
(228.3%)
18.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 56 participants
36.706  (27.6193)
Day 29 Number Analyzed 48 participants
37.731  (19.9473)
19.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 56 participants
77.827  (24.2897)
Day 29 Number Analyzed 48 participants
71.667  (23.8395)
20.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 56 participants
83.333  (17.4078)
Day 29 Number Analyzed 48 participants
88.194  (14.9698)
21.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health/QoL Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 56 participants
66.815  (25.5491)
Day 29 Number Analyzed 48 participants
72.049  (18.7910)
22.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 56 participants
77.083  (30.4117)
Day 29 Number Analyzed 48 participants
69.792  (28.0695)
23.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 55 participants
81.061  (17.1575)
Day 29 Number Analyzed 48 participants
86.806  (13.4077)
24.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 56 participants
74.702  (26.3985)
Day 29 Number Analyzed 48 participants
72.917  (25.8713)
25.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 56 participants
26.488  (29.2631)
Day 29 Number Analyzed 48 participants
13.542  (22.4546)
26.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea/Vomiting Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 56 participants
5.655  (10.6727)
Day 29 Number Analyzed 48 participants
6.250  (14.4338)
27.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 56 participants
11.905  (23.2931)
Day 29 Number Analyzed 48 participants
6.944  (13.6805)
28.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 56 participants
13.690  (21.8135)
Day 29 Number Analyzed 48 participants
11.806  (21.1821)
29.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 56 participants
25.595  (27.7005)
Day 29 Number Analyzed 48 participants
20.139  (27.2798)
30.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 56 participants
10.714  (21.1843)
Day 29 Number Analyzed 48 participants
13.194  (17.8510)
31.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 55 participants
18.788  (29.9270)
Day 29 Number Analyzed 48 participants
22.222  (28.6277)
32.Secondary Outcome
Title Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties Subscale
Hide Description
  • 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 56 participants
13.690  (22.7208)
Day 29 Number Analyzed 48 participants
14.583  (21.6421)
33.Secondary Outcome
Title Health-Related Quality of Life (HRQoL) Assessed by the FACT-Lym Subscale
Hide Description 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 49
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 49 participants
44.22  (8.804)
Day 29 Number Analyzed 42 participants
48.71  (6.447)
34.Secondary Outcome
Title Health-Related Quality of Life (HRQoL) Assessed by the EuroQol Instrument EQ-5D-5L
Hide Description 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.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one JCAR017 infusion who completed 5-dimension measures at baseline and at least one post-baseline
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 55 participants
0.7378  (0.23190)
Day 29 Number Analyzed 46 participants
0.7719  (0.20651)
35.Secondary Outcome
Title Numbers of Intensive Care Unit (ICU) Inpatient Days
Hide Description The numbers of ICU inpatient days.
Time Frame From first dose after JCAR017 infusion to up to approximately 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one infusion of JCAR017 who were monitored inpatient
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 41
Median (Full Range)
Unit of Measure: Day
0.0
(0 to 3)
36.Secondary Outcome
Title Numbers of Non-intensive Care Unit (ICU) Inpatient Days
Hide Description Number of non-ICU inpatient days.
Time Frame From first dose after JCAR017 infusion to up to approximately 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one infusion of JCAR017 who were monitored inpatient
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 41
Median (Full Range)
Unit of Measure: Day
12.0
(3 to 24)
37.Secondary Outcome
Title The Number of Participants That Were Hospitalized For Adverse Events, Prophylaxis, Other
Hide Description 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.
Time Frame From first dose after JCAR017 infusion to up to approximately 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one infusion of JCAR017 who were monitored inpatient
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
Adverse Event 3
Prophylaxis for CAR T-cell administration 36
Other 2
Time Frame Participants were assessed for all-cause mortality from their first dose until primary completion (up to approximately 38 months). SAEs and Other AEs were assessed from first dose to 90 days following first dose (up to approximately 90 days).
Adverse Event Reporting Description The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).
 
Arm/Group Title Lisocabtagene Maraleucel (JCAR017)
Hide Arm/Group Description 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.
All-Cause Mortality
Lisocabtagene Maraleucel (JCAR017)
Affected / at Risk (%)
Total   26/74 (35.14%) 
Hide Serious Adverse Events
Lisocabtagene Maraleucel (JCAR017)
Affected / at Risk (%)
Total   20/61 (32.79%) 
Blood and lymphatic system disorders   
Febrile neutropenia † 1  1/61 (1.64%) 
Gastrointestinal disorders   
Lower gastrointestinal haemorrhage † 1  1/61 (1.64%) 
Obstruction gastric † 1  1/61 (1.64%) 
Upper gastrointestinal haemorrhage † 1  2/61 (3.28%) 
Immune system disorders   
Cytokine release syndrome † 1  8/61 (13.11%) 
Infections and infestations   
Bacteraemia † 1  1/61 (1.64%) 
COVID-19 † 1  1/61 (1.64%) 
COVID-19 pneumonia † 1  1/61 (1.64%) 
Staphylococcal infection † 1  1/61 (1.64%) 
Stenotrophomonas sepsis † 1  1/61 (1.64%) 
Injury, poisoning and procedural complications   
Fall † 1  1/61 (1.64%) 
Hip fracture † 1  1/61 (1.64%) 
Investigations   
Blood bilirubin increased † 1  1/61 (1.64%) 
Weight decreased † 1  1/61 (1.64%) 
Metabolism and nutrition disorders   
Decreased appetite † 1  1/61 (1.64%) 
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  1/61 (1.64%) 
Muscular weakness † 1  2/61 (3.28%) 
Neck pain † 1  1/61 (1.64%) 
Nervous system disorders   
Headache † 1  1/61 (1.64%) 
Psychiatric disorders   
Confusional state † 1  3/61 (4.92%) 
Disorientation † 1  1/61 (1.64%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism † 1  2/61 (3.28%) 
Vascular disorders   
Hypotension † 1  1/61 (1.64%) 
1
Term from vocabulary, MedDRA 23.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lisocabtagene Maraleucel (JCAR017)
Affected / at Risk (%)
Total   59/61 (96.72%) 
Blood and lymphatic system disorders   
Anaemia † 1  19/61 (31.15%) 
Leukopenia † 1  14/61 (22.95%) 
Lymphopenia † 1  8/61 (13.11%) 
Neutropenia † 1  31/61 (50.82%) 
Thrombocytopenia † 1  17/61 (27.87%) 
Gastrointestinal disorders   
Constipation † 1  8/61 (13.11%) 
Diarrhoea † 1  10/61 (16.39%) 
Nausea † 1  15/61 (24.59%) 
Vomiting † 1  5/61 (8.20%) 
General disorders   
Asthenia † 1  5/61 (8.20%) 
Fatigue † 1  24/61 (39.34%) 
Oedema peripheral † 1  9/61 (14.75%) 
Pyrexia † 1  5/61 (8.20%) 
Immune system disorders   
Cytokine release syndrome † 1  15/61 (24.59%) 
Hypogammaglobulinaemia † 1  4/61 (6.56%) 
Injury, poisoning and procedural complications   
Fall † 1  5/61 (8.20%) 
Investigations   
Neutrophil count decreased † 1  5/61 (8.20%) 
Metabolism and nutrition disorders   
Decreased appetite † 1  7/61 (11.48%) 
Hypokalaemia † 1  11/61 (18.03%) 
Hypomagnesaemia † 1  11/61 (18.03%) 
Hyponatraemia † 1  5/61 (8.20%) 
Hypophosphataemia † 1  5/61 (8.20%) 
Musculoskeletal and connective tissue disorders   
Back pain † 1  4/61 (6.56%) 
Pain in extremity † 1  6/61 (9.84%) 
Nervous system disorders   
Dizziness † 1  8/61 (13.11%) 
Headache † 1  7/61 (11.48%) 
Lethargy † 1  4/61 (6.56%) 
Tremor † 1  10/61 (16.39%) 
Psychiatric disorders   
Anxiety † 1  5/61 (8.20%) 
Confusional state † 1  6/61 (9.84%) 
Depression † 1  4/61 (6.56%) 
Insomnia † 1  8/61 (13.11%) 
Renal and urinary disorders   
Acute kidney injury † 1  4/61 (6.56%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1  8/61 (13.11%) 
Dyspnoea † 1  7/61 (11.48%) 
Productive cough † 1  4/61 (6.56%) 
Vascular disorders   
Hypertension † 1  6/61 (9.84%) 
Hypotension † 1  10/61 (16.39%) 
Orthostatic hypotension † 1  4/61 (6.56%) 
1
Term from vocabulary, MedDRA 23.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: 855-907-3286
EMail: Clinical.Trials@bms.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Juno Therapeutics, a Subsidiary of Celgene
ClinicalTrials.gov Identifier: NCT03483103    
Other Study ID Numbers: 017006
First Submitted: March 23, 2018
First Posted: March 30, 2018
Results First Submitted: September 23, 2022
Results First Posted: December 29, 2022
Last Update Posted: January 13, 2023