Study Evaluating KTE-X19 in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

Official Title

A Phase 1/2 Multi-Centre Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

Summary:

The primary objectives of this study are to evaluate the safety and efficacy of KTE-X19 in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL).

Trial Description

Primary Outcome:

  • Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLT)
  • Phase 2: Overall Complete Remission Rate in the ALL Cohort
  • Phase 2: Objective Response Rate in the NHL Cohorts
Secondary Outcome:
  • Minimum Residual Disease Negative Remission Rate in the ALL Cohort
  • Allogeneic Stem Cell Transplant Rate in the ALL Cohort
  • Changes Over Time in PRO Scores in the ALL Cohort
  • Overall Complete Remission Rate in the ALL Cohort
  • Relapse-Free Survival for the ALL Cohort
  • Progression Free Survival in the NHL Cohort
  • Overall Survival in the ALL and NHL Cohorts
  • Duration of Remission in the ALL and NHL Cohorts
  • Percentage of Participants with Anti-KTE-X19 Antibodies in Blood in the ALL and NHL Cohorts
  • Percentage of Participants Experiencing Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) Grade Changes in Safety Laboratory Values in ALL and NHL Cohorts

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