Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03575351 · OUTCOME

Overall Response Rate (ORR) 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to PR or CR (Up to 36 months)

What was measured

ORR is defined as the percentage of participants achieving a best overall response of partial response (PR) or complete response (CR). 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. 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.

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

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 Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm51.7Not reported38.265.0Not reported
Liso-cel Arm86.7Not reported75.494.1Not reported
NIH: Follicular Lymphoma Grade 3B

Analysis denominator · Participants

GroupSource count
Standard of Care Arm0
Liso-cel Arm1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Liso-cel Arm100Not reported2.5100.0Not reported
NIH: High-Grade B-cell Lymphoma with DLBCL Histology

Analysis denominator · Participants

GroupSource count
Standard of Care Arm21
Liso-cel Arm22
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm42.9Not reported21.866.0Not reported
Liso-cel Arm81.8Not reported59.794.8Not reported
NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma

Analysis denominator · Participants

GroupSource count
Standard of Care Arm9
Liso-cel Arm8
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm33.3Not reported7.570.1Not reported
Liso-cel Arm100Not reported63.1100.0Not reported
NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma

Analysis denominator · Participants

GroupSource count
Standard of Care Arm4
Liso-cel Arm1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm75.0Not reported19.499.4Not reported
Liso-cel Arm100Not reported2.5100.0Not reported
Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo

Analysis denominator · Participants

GroupSource count
Standard of Care Arm50
Liso-cel Arm53
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm54.0Not reported39.368.2Not reported
Liso-cel Arm86.8Not reported74.794.5Not reported
DLBCL: DLBCL from Transformed Indolent NHL

Analysis denominator · Participants

GroupSource count
Standard of Care Arm8
Liso-cel Arm7
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm37.5Not reported8.575.5Not reported
Liso-cel Arm85.7Not reported42.199.6Not reported
DLBCL: Germinal Center B-cell like (GCB)

Analysis denominator · Participants

GroupSource count
Standard of Care Arm40
Liso-cel Arm45
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm50.0Not reported33.866.2Not reported
Liso-cel Arm91.1Not reported78.897.5Not reported
DLBCL: Activated B-cell-like, non-GCB

Analysis denominator · Participants

GroupSource count
Standard of Care Arm29
Liso-cel Arm21
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm44.8Not reported26.464.3Not reported
Liso-cel Arm85.7Not reported63.797.0Not reported
NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL)

Analysis denominator · Participants

GroupSource count
Standard of Care Arm20
Liso-cel Arm22
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm40.0Not reported19.163.9Not reported
Liso-cel Arm81.8Not reported59.794.8Not reported
NHL: Non-DHL/THL

Analysis denominator · Participants

GroupSource count
Standard of Care Arm72
Liso-cel Arm70
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care Arm51.4Not reported39.363.3Not reported
Liso-cel Arm88.6Not reported78.794.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.2
        upper Limit
        65.0
        value
        51.7
      2. group Id
        OG001
        lower Limit
        75.4
        upper Limit
        94.1
        value
        86.7
    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. group Id
        OG001
        lower Limit
        2.5
        upper Limit
        100.0
        value
        100
    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
        21.8
        upper Limit
        66.0
        value
        42.9
      2. group Id
        OG001
        lower Limit
        59.7
        upper Limit
        94.8
        value
        81.8
    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. group Id
        OG000
        lower Limit
        7.5
        upper Limit
        70.1
        value
        33.3
      2. group Id
        OG001
        lower Limit
        63.1
        upper Limit
        100.0
        value
        100
    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. group Id
        OG000
        lower Limit
        19.4
        upper Limit
        99.4
        value
        75.0
      2. group Id
        OG001
        lower Limit
        2.5
        upper Limit
        100.0
        value
        100
    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
        39.3
        upper Limit
        68.2
        value
        54.0
      2. group Id
        OG001
        lower Limit
        74.7
        upper Limit
        94.5
        value
        86.8
    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
        8.5
        upper Limit
        75.5
        value
        37.5
      2. group Id
        OG001
        lower Limit
        42.1
        upper Limit
        99.6
        value
        85.7
    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
        33.8
        upper Limit
        66.2
        value
        50.0
      2. group Id
        OG001
        lower Limit
        78.8
        upper Limit
        97.5
        value
        91.1
    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
        26.4
        upper Limit
        64.3
        value
        44.8
      2. group Id
        OG001
        lower Limit
        63.7
        upper Limit
        97.0
        value
        85.7
    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
        19.1
        upper Limit
        63.9
        value
        40.0
      2. group Id
        OG001
        lower Limit
        59.7
        upper Limit
        94.8
        value
        81.8
    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
        39.3
        upper Limit
        63.3
        value
        51.4
      2. group Id
        OG001
        lower Limit
        78.7
        upper Limit
        94.9
        value
        88.6
    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
ORR is defined as the percentage of participants achieving a best overall response of partial response (PR) or complete response (CR). 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. 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.
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 per clinical, histological and molecular subgroups that are pre-specified for ORR (subgroups are not mutually exclusive and participants are not exclusive to one subgroup)
reporting Status
POSTED
time Frame
From randomization to PR or CR (Up to 36 months)
title
Overall Response Rate (ORR) by Subgroups
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice