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NCT03575351 · OUTCOME

Event-free Survival (EFS) by Subgroups

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas · Source last updated 2025-08-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months)

What was measured

Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. PD: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.

Analysis population: All randomized participants per clinical, histological and molecular subgroups that are pre-specified for EFS (subgroups are not mutually exclusive)

Groups in this outcome

Standard of Care Arm

3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks

Liso-cel Arm

\[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Standard of Care Arm72
Liso-cel Arm70

Reported measurements

Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL)

Analysis denominator · Participants

GroupSource count
Standard of Care Arm58
Liso-cel Arm60
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm3.0Not reported2.26.4Not reported
Liso-cel ArmNANot reported9.5NAMedian and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
NIH: Follicular Lymphoma Grade 3B

Analysis denominator · Participants

GroupSource count
Standard of Care Arm0
Liso-cel Arm1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Liso-cel ArmNANot reportedNANAMedian, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
NIH: High-Grade B-cell Lymphoma with DLBCL Histology

Analysis denominator · Participants

GroupSource count
Standard of Care Arm21
Liso-cel Arm22
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm2.2Not reported0.93.9Not reported
Liso-cel Arm4.6Not reported4.112.6Not reported
NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma

Analysis denominator · Participants

GroupSource count
Standard of Care Arm9
Liso-cel Arm8
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm2.2Not reported1.0NAThe upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Liso-cel ArmNANot reported11.0NAMedian and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma

Analysis denominator · Participants

GroupSource count
Standard of Care Arm4
Liso-cel Arm1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care ArmNANot reported2.3NAMedian and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Liso-cel ArmNANot reportedNANAMedian, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo

Analysis denominator · Participants

GroupSource count
Standard of Care Arm50
Liso-cel Arm53
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm4.4Not reported2.27.5Not reported
Liso-cel Arm33.2Not reported9.4NAThe upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
DLBCL: DLBCL from Transformed Indolent NHL

Analysis denominator · Participants

GroupSource count
Standard of Care Arm8
Liso-cel Arm7
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm2.1Not reported1.211.2Not reported
Liso-cel ArmNANot reported1.9NAMedian and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
DLBCL: Germinal Center B-cell like (GCB)

Analysis denominator · Participants

GroupSource count
Standard of Care Arm40
Liso-cel Arm45
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm2.1Not reported1.64.9Not reported
Liso-cel Arm11.7Not reported6.0NAThe upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
DLBCL: Activated B-cell-like, non-GCB

Analysis denominator · Participants

GroupSource count
Standard of Care Arm29
Liso-cel Arm21
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm2.3Not reported2.17.5Not reported
Liso-cel Arm33.2Not reported4.9NAThe upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL)

Analysis denominator · Participants

GroupSource count
Standard of Care Arm20
Liso-cel Arm22
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm2.1Not reported0.93.9Not reported
Liso-cel Arm4.6Not reported4.112.6Not reported
NHL: Non-DHL/THL

Analysis denominator · Participants

GroupSource count
Standard of Care Arm72
Liso-cel Arm70
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm2.8Not reported2.26.4Not reported
Liso-cel ArmNANot reported15.6NAMedian and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.2
        upper Limit
        6.4
        value
        3.0
      2. comment
        Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        9.5
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        60
      units
      Participants
    title
    Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL)
  2. categories
    1. measurements
      1. comment
        Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    NIH: Follicular Lymphoma Grade 3B
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        3.9
        value
        2.2
      2. group Id
        OG001
        lower Limit
        4.1
        upper Limit
        12.6
        value
        4.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    NIH: High-Grade B-cell Lymphoma with DLBCL Histology
  4. categories
    1. measurements
      1. comment
        The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        1.0
        upper Limit
        NA
        value
        2.2
      2. comment
        Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        11.0
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma
  5. categories
    1. measurements
      1. comment
        Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        2.3
        upper Limit
        NA
        value
        NA
      2. comment
        Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.2
        upper Limit
        7.5
        value
        4.4
      2. comment
        The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        9.4
        upper Limit
        NA
        value
        33.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        53
      units
      Participants
    title
    Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.2
        upper Limit
        11.2
        value
        2.1
      2. comment
        Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        1.9
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    DLBCL: DLBCL from Transformed Indolent NHL
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.6
        upper Limit
        4.9
        value
        2.1
      2. comment
        The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        6.0
        upper Limit
        NA
        value
        11.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        45
      units
      Participants
    title
    DLBCL: Germinal Center B-cell like (GCB)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        7.5
        value
        2.3
      2. comment
        The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        4.9
        upper Limit
        NA
        value
        33.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    DLBCL: Activated B-cell-like, non-GCB
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        3.9
        value
        2.1
      2. group Id
        OG001
        lower Limit
        4.1
        upper Limit
        12.6
        value
        4.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL)
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.2
        upper Limit
        6.4
        value
        2.8
      2. comment
        Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        15.6
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        72
      2. group Id
        OG001
        value
        70
      units
      Participants
    title
    NHL: Non-DHL/THL
denoms
  1. counts
    1. group Id
      OG000
      value
      72
    2. group Id
      OG001
      value
      70
    units
    Participants
description
Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. PD: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.
dispersion Type
95% Confidence Interval
groups
  1. description
    3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
    id
    OG000
    title
    Standard of Care Arm
  2. description
    \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
    id
    OG001
    title
    Liso-cel Arm
param Type
MEDIAN
population Description
All randomized participants per clinical, histological and molecular subgroups that are pre-specified for EFS (subgroups are not mutually exclusive)
reporting Status
POSTED
time Frame
From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months)
title
Event-free Survival (EFS) by Subgroups
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice