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NCT03575351 · OUTCOME

Event-free Survival (EFS) Rate

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Months 6, 12, 18, 24, 36

What was measured

EFS rate is defined as the percentage of participants free of any EFS event at fixed timepoints. Complete response: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. Partial response: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. Progression: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Metabolic progression: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.

Analysis population: All randomized participants

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 Arm92
Liso-cel Arm92

Reported measurements

EFS Rate at 6 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm36.2Not reported26.346.1Not reported
Liso-cel Arm68.1Not reported58.677.7Not reported
EFS Rate at 12 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm22.6Not reported13.931.3Not reported
Liso-cel Arm57.0Not reported46.867.2Not reported
EFS Rate at 18 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm22.6Not reported13.931.3Not reported
Liso-cel Arm52.6Not reported42.362.8Not reported
EFS Rate at 24 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm21.5Not reported13.030.0Not reported
Liso-cel Arm51.4Not reported41.161.7Not reported
EFS Rate at 36 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm19.1Not reported11.027.3Not reported
Liso-cel Arm45.8Not reported35.256.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26.3
        upper Limit
        46.1
        value
        36.2
      2. group Id
        OG001
        lower Limit
        58.6
        upper Limit
        77.7
        value
        68.1
    title
    EFS Rate at 6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.9
        upper Limit
        31.3
        value
        22.6
      2. group Id
        OG001
        lower Limit
        46.8
        upper Limit
        67.2
        value
        57.0
    title
    EFS Rate at 12 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.9
        upper Limit
        31.3
        value
        22.6
      2. group Id
        OG001
        lower Limit
        42.3
        upper Limit
        62.8
        value
        52.6
    title
    EFS Rate at 18 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.0
        upper Limit
        30.0
        value
        21.5
      2. group Id
        OG001
        lower Limit
        41.1
        upper Limit
        61.7
        value
        51.4
    title
    EFS Rate at 24 months
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.0
        upper Limit
        27.3
        value
        19.1
      2. group Id
        OG001
        lower Limit
        35.2
        upper Limit
        56.5
        value
        45.8
    title
    EFS Rate at 36 months
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    2. group Id
      OG001
      value
      92
    units
    Participants
description
EFS rate is defined as the percentage of participants free of any EFS event at fixed timepoints. Complete response: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. Partial response: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. Progression: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Metabolic progression: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.
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
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
Months 6, 12, 18, 24, 36
title
Event-free Survival (EFS) Rate
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice