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NCT03575351 · OUTCOME

Progression-free Survival (PFS) 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

Progression-free Survival (PFS) rate is defined as the percentage of participants free of any PFS event at fixed timepoints. Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.

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

PFS Rate at 6 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm51.7Not reported40.263.1Not reported
Liso-cel Arm73.7Not reported64.583.0Not reported
PFS Rate at 12 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm31.3Not reported20.342.4Not reported
Liso-cel Arm63.0Not reported52.873.2Not reported
PFS Rate at 18 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm31.3Not reported20.342.4Not reported
Liso-cel Arm58.2Not reported47.768.7Not reported
PFS Rate at 24 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm29.7Not reported18.840.7Not reported
Liso-cel Arm57.0Not reported46.467.5Not reported
PFS Rate at 36 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm26.5Not reported15.937.1Not reported
Liso-cel Arm50.9Not reported39.962.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40.2
        upper Limit
        63.1
        value
        51.7
      2. group Id
        OG001
        lower Limit
        64.5
        upper Limit
        83.0
        value
        73.7
    title
    PFS Rate at 6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.3
        upper Limit
        42.4
        value
        31.3
      2. group Id
        OG001
        lower Limit
        52.8
        upper Limit
        73.2
        value
        63.0
    title
    PFS Rate at 12 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.3
        upper Limit
        42.4
        value
        31.3
      2. group Id
        OG001
        lower Limit
        47.7
        upper Limit
        68.7
        value
        58.2
    title
    PFS Rate at 18 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.8
        upper Limit
        40.7
        value
        29.7
      2. group Id
        OG001
        lower Limit
        46.4
        upper Limit
        67.5
        value
        57.0
    title
    PFS Rate at 24 months
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.9
        upper Limit
        37.1
        value
        26.5
      2. group Id
        OG001
        lower Limit
        39.9
        upper Limit
        62.0
        value
        50.9
    title
    PFS Rate at 36 months
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    2. group Id
      OG001
      value
      92
    units
    Participants
description
Progression-free Survival (PFS) rate is defined as the percentage of participants free of any PFS event at fixed timepoints. Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.
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
Progression-free Survival (PFS) Rate
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice