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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)

NCT02614066 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-11-19

Study results available
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Summary

The primary objectives of this study are to determine the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).

Conditions

  • Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Interventions

BIOLOGICAL

brexucabtagene autoleucel

A single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered intravenously.

DRUG

Cyclophosphamide

Administered intravenously.

DRUG

Fludarabine

Administered intravenously.

Sponsors & Collaborators

  • Kite, A Gilead Company

    lead INDUSTRY

Principal Investigators

  • Kite Study Director · Kite, A Gilead Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-07
Primary Completion
2022-07-23
Completion
2023-11-03
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02614066 on ClinicalTrials.gov