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NCT03575351 · OUTCOME

Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym)

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
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
baseline, months 1, 6, 9, 12, 18, 24, 36

What was measured

Change from Baseline in the Functional Assessment of Cancer Therapy-Lymphoma 15-item lymphoma-specific "Additional concerns" subscale (FACT-Lym). 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. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). A meaningful change from baseline in the FACT-Lym score, often referred to as the minimally important difference (MID), typically ranges between 6.5 and 11.2 points for the total score. This range indicates a clinically significant improvement or deterioration in a patient's health-related quality of life.

Analysis population: All treated participants with a health-related quality of life baseline assessment value and a post-baseline value at the time point

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 Arm38
Liso-cel Arm40

Reported measurements

Month 1

Analysis denominator · Participants

GroupSource count
Standard of Care Arm38
Liso-cel Arm40
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Standard of Care Arm-0.765.558Not reportedNot reportedNot reported
Liso-cel Arm0.357.329Not reportedNot reportedNot reported
Month 6

Analysis denominator · Participants

GroupSource count
Standard of Care Arm16
Liso-cel Arm29
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Standard of Care Arm2.199.474Not reportedNot reportedNot reported
Liso-cel Arm3.5210.805Not reportedNot reportedNot reported
Month 9

Analysis denominator · Participants

GroupSource count
Standard of Care Arm9
Liso-cel Arm23
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Standard of Care Arm0.119.597Not reportedNot reportedNot reported
Liso-cel Arm5.4814.330Not reportedNot reportedNot reported
Month 12

Analysis denominator · Participants

GroupSource count
Standard of Care Arm7
Liso-cel Arm27
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Standard of Care Arm5.433.645Not reportedNot reportedNot reported
Liso-cel Arm3.9313.485Not reportedNot reportedNot reported
Month 18

Analysis denominator · Participants

GroupSource count
Standard of Care Arm8
Liso-cel Arm25
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Standard of Care Arm3.505.632Not reportedNot reportedNot reported
Liso-cel Arm2.5612.149Not reportedNot reportedNot reported
Month 24

Analysis denominator · Participants

GroupSource count
Standard of Care Arm10
Liso-cel Arm22
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Standard of Care Arm5.205.789Not reportedNot reportedNot reported
Liso-cel Arm2.1812.374Not reportedNot reportedNot reported
Month 36

Analysis denominator · Participants

GroupSource count
Standard of Care Arm10
Liso-cel Arm24
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Standard of Care Arm4.905.152Not reportedNot reportedNot reported
Liso-cel Arm0.509.478Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.558
        value
        -0.76
      2. group Id
        OG001
        spread
        7.329
        value
        0.35
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        40
      units
      Participants
    title
    Month 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.474
        value
        2.19
      2. group Id
        OG001
        spread
        10.805
        value
        3.52
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        29
      units
      Participants
    title
    Month 6
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.597
        value
        0.11
      2. group Id
        OG001
        spread
        14.330
        value
        5.48
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    Month 9
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.645
        value
        5.43
      2. group Id
        OG001
        spread
        13.485
        value
        3.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        27
      units
      Participants
    title
    Month 12
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.632
        value
        3.50
      2. group Id
        OG001
        spread
        12.149
        value
        2.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        25
      units
      Participants
    title
    Month 18
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.789
        value
        5.20
      2. group Id
        OG001
        spread
        12.374
        value
        2.18
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Month 24
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.152
        value
        4.90
      2. group Id
        OG001
        spread
        9.478
        value
        0.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Month 36
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      40
    units
    Participants
description
Change from Baseline in the Functional Assessment of Cancer Therapy-Lymphoma 15-item lymphoma-specific "Additional concerns" subscale (FACT-Lym). 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. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). A meaningful change from baseline in the FACT-Lym score, often referred to as the minimally important difference (MID), typically ranges between 6.5 and 11.2 points for the total score. This range indicates a clinically significant improvement or deterioration in a patient's health-related quality of life.
dispersion Type
Standard Deviation
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
MEAN
population Description
All treated participants with a health-related quality of life baseline assessment value and a post-baseline value at the time point
reporting Status
POSTED
time Frame
baseline, months 1, 6, 9, 12, 18, 24, 36
title
Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym)
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice