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NCT03483103 · OUTCOME

Health-Related Quality of Life (HRQoL) Assessed by the FACT-Lym Subscale

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006) · Source last updated 2023-12-20

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

Measure
MEAN
Unit
Scores on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline and Day 29

What was measured

The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. 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.

Analysis population: All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale

Groups in this outcome

Lisocabtagene Maraleucel (JCAR017)

Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting 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
Lisocabtagene Maraleucel (JCAR017)49

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Lisocabtagene Maraleucel (JCAR017)49
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)44.228.804Not reportedNot reportedNot reported
Day 29

Analysis denominator · Participants

GroupSource count
Lisocabtagene Maraleucel (JCAR017)42
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)48.716.447Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.804
        value
        44.22
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.447
        value
        48.71
    denoms
    1. counts
      1. group Id
        OG000
        value
        42
      units
      Participants
    title
    Day 29
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    units
    Participants
description
The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. 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.
dispersion Type
Standard Deviation
groups
  1. description
    Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
    id
    OG000
    title
    Lisocabtagene Maraleucel (JCAR017)
param Type
MEAN
population Description
All participants who received at least one JCAR017 infusion who has an analyzable baseline scale and at least one post-baseline analyzable scale
reporting Status
POSTED
time Frame
Baseline and Day 29
title
Health-Related Quality of Life (HRQoL) Assessed by the FACT-Lym Subscale
type
SECONDARY
unit Of Measure
Scores on a scale

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

Preserved source evidence · Not medical advice