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NCT02614066 · OUTCOME

Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 5 years

What was measured

Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening.

Analysis population: Participants in Safety 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

Hematology: Lymphocytes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg1Not reportedNot reportedNot reportedNot reported
Hematology: Leukocytes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg4Not reportedNot reportedNot reportedNot reported
Hematology: Hemoglobin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg0Not reportedNot reportedNot reportedNot reported
Hematology: Neutrophils
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg0Not reportedNot reportedNot reportedNot reported
Hematology: Platelets
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg0Not reportedNot reportedNot reportedNot reported
Chemistry: Creatinine
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg4Not reportedNot reportedNot reportedNot reported
Chemistry: Glucose
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg13Not reportedNot reportedNot reportedNot reported
Chemistry: Aspartate Aminotransferase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg14Not reportedNot reportedNot reportedNot reported
Chemistry: Alanine Aminotransferase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg17Not reportedNot reportedNot reportedNot reported
Chemistry: Bilirubin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg5Not reportedNot reportedNot reportedNot reported
Chemistry: Alkaline Phosphatase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg3Not reportedNot reportedNot reportedNot reported
Chemistry: Direct Bilirubin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg8Not reportedNot reportedNot reportedNot reported
Chemistry: Urate
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg12Not reportedNot reportedNot reportedNot reported
Chemistry: Sodium
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg1Not reportedNot reportedNot reportedNot reported
Chemistry: Potassium
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg2Not reportedNot reportedNot reportedNot reported
Chemistry: Magnesium
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg3Not reportedNot reportedNot reportedNot reported
Chemistry: Calcium
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg0Not reportedNot reportedNot reportedNot reported
Chemistry: Albumin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg0Not reportedNot reportedNot reportedNot reported
Chemistry: Phosphate
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg0Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hematology: Lymphocytes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Hematology: Leukocytes
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hematology: Hemoglobin
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hematology: Neutrophils
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hematology: Platelets
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Chemistry: Creatinine
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Chemistry: Glucose
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Chemistry: Aspartate Aminotransferase
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Chemistry: Alanine Aminotransferase
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Chemistry: Bilirubin
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Chemistry: Alkaline Phosphatase
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Chemistry: Direct Bilirubin
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    units
    Participants
description
Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening.
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
COUNT_OF_PARTICIPANTS
population Description
Participants in Safety Analysis Set were analyzed.
reporting Status
POSTED
time Frame
Up to 5 years
title
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice