NCT03483103 · OUTCOME

Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia 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

* Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. * The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. * All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. * Symptom scale/item higher score represents a high level of symptomatic problem.

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

Group	Source count
Lisocabtagene Maraleucel (JCAR017)	56

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Lisocabtagene Maraleucel (JCAR017)	56

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Lisocabtagene Maraleucel (JCAR017)	25.595	27.7005	Not reported	Not reported	Not reported

Day 29

Analysis denominator · Participants

Group	Source count
Lisocabtagene Maraleucel (JCAR017)	48

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Lisocabtagene Maraleucel (JCAR017)	20.139	27.2798	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
27.7005
value
25.595
denoms
counts
group Id
OG000
value
56
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
27.2798
value
20.139
denoms
counts
group Id
OG000
value
48
units
Participants
title
Day 29

denoms

counts
group Id
OG000
value
56
units
Participants

description

dispersion Type

Standard Deviation

groups

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

Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia Subscale

type

SECONDARY

unit Of Measure

Scores on a scale

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

Preserved source evidence · Not medical advice