Study Evaluating KTE-C19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Official Title

A Phase 1/2 Multi-Centre Study Evaluating the Safety and Efficacy of KTE-C19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-4)

Summary:

The primary objectives of this study are to evaluate the safety and efficacy of KTE-C19 in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).

Trial Description

Primary Outcome:

  • Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLT)
  • Phase 2: Overall Complete Remission Rate
Secondary Outcome:
  • Duration of Remission
  • Minimum Residual Disease Negative Remission Rate
  • Allogeneic Stem Cell Transplant Rate
  • Overall Survival
  • Relapse-Free Survival
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events
  • Percentage of Participants Experiencing Common Terminology Criteria for Adverse Events (CTCAE) Grade Changes in Safety Laboratory Values
  • Percentage of Participants with Anti-KTE-C19 Antibodies

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society