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NCT03792633 · OUTCOME

Percentage of Subjects With Relapse-free Survival

Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL · Source last updated 2025-06-05

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

Measure
NUMBER
Unit
percentage of subjects
Interval / dispersion
95% Confidence Interval
Time frame
1 year

What was measured

Time from first response of CR/CRi to the first of event or censoring, in responders. Cohort A: Events = Relapse or Death; Censoring = Initiation of New Anticancer Therapy, Last Day of Follow-up/EOS; whichever occurs first. Cohort B: When defining responders, CR/CRi without B Cell Aplasia is considered no response. Events = Relapse or Death; Censoring = Initiation of New Anticancer Therapy, Last Day of Follow-up/EOS; whichever occurs first.

Groups in this outcome

Cohort A

Patients with newly diagnosed VHR B-ALL or high-risk relapse of B-ALL

Cohort B

Patients with poor response to prior B cell directed engineered cell therapy

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort A52
Cohort B48

Reported measurements

Source class 1
Values in percentage of subjects · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A76.3Not reported64.390.4Not reported
Cohort B80.4Not reported67.495.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        64.3
        upper Limit
        90.4
        value
        76.3
      2. group Id
        OG001
        lower Limit
        67.4
        upper Limit
        95.4
        value
        80.4
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    2. group Id
      OG001
      value
      48
    units
    Participants
description
Time from first response of CR/CRi to the first of event or censoring, in responders. Cohort A: Events = Relapse or Death; Censoring = Initiation of New Anticancer Therapy, Last Day of Follow-up/EOS; whichever occurs first. Cohort B: When defining responders, CR/CRi without B Cell Aplasia is considered no response. Events = Relapse or Death; Censoring = Initiation of New Anticancer Therapy, Last Day of Follow-up/EOS; whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with newly diagnosed VHR B-ALL or high-risk relapse of B-ALL
    id
    OG000
    title
    Cohort A
  2. description
    Patients with poor response to prior B cell directed engineered cell therapy
    id
    OG001
    title
    Cohort B
param Type
NUMBER
reporting Status
POSTED
time Frame
1 year
title
Percentage of Subjects With Relapse-free Survival
type
SECONDARY
unit Of Measure
percentage of subjects

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

Preserved source evidence · Not medical advice