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NCT02614066 · OUTCOME

Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years

What was measured

MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. Percentage of participants with MRD negative remission was reported. 95% CI was calculated by Clopper-Pearson method.

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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg76Not reported6387Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        63
        upper Limit
        87
        value
        76
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    units
    Participants
description
MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. Percentage of participants with MRD negative remission was reported. 95% CI was calculated by Clopper-Pearson method.
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
NUMBER
population Description
Participants in mITT Analysis Set were analyzed.
reporting Status
POSTED
time Frame
First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years
title
Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice