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NCT02614066 · OUTCOME

Phase 2: Overall Survival (OS)

A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3) · Source last updated 2024-11-19

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
First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years

What was measured

OS was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Participants who had not died by the analysis data cutoff date were censored at their last contact date. KM estimates was used for analyses.

Analysis population: Participants in mITT Analysis Set were analyzed.

Groups in this outcome

Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg

Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.

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

Analysis denominator · Participants

GroupSource count
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg55

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg26.0Not reported16.2NAUpper limit of confidence interval was not estimable due to insufficient number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of confidence interval was not estimable due to insufficient number of events.
        group Id
        OG000
        lower Limit
        16.2
        upper Limit
        NA
        value
        26.0
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    units
    Participants
description
OS was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Participants who had not died by the analysis data cutoff date were censored at their last contact date. KM estimates was used for analyses.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
    id
    OG000
    title
    Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg
param Type
MEDIAN
population Description
Participants in mITT Analysis Set were analyzed.
reporting Status
POSTED
time Frame
First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years
title
Phase 2: Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice