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NCT03483103 · OUTCOME

Overall Survival (OS)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From first dose to date of death (up to approximately 24 months)

What was measured

OS is defined as the time from JCAR017 infusion to the date of death. Kaplan-Meier (KM) methodology will be used to analyze OS.

Analysis population: All participants with PET positive disease who received at least one infusion of JCAR017

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)61

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)NANot reported16.33NAInsufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        16.33
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    units
    Participants
description
OS is defined as the time from JCAR017 infusion to the date of death. Kaplan-Meier (KM) methodology will be used to analyze OS.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
All participants with PET positive disease who received at least one infusion of JCAR017
reporting Status
POSTED
time Frame
From first dose to date of death (up to approximately 24 months)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice