A Phase II Study of Daratumumab in Children and Young Adults with Recurrent or Persistent Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Full Title

An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma.

Purpose

The purpose of this study is to assess the safety and effectiveness of the anticancer drug daratumumab when given in combination with standard chemotherapy in children and young adults with B-cell or T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that has come back or continued to grow despite prior treatment.

Daratumumab targets a protein on cancer cells called CD38. It is used to treat multiple myeloma; its use in this study is considered investigational. It is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that persists despite at least two prior regimens of therapy, or T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that persists despite at least one prior regimen of therapy.
  • Patients should recover from the serious side effects of previous treatment before entering the study.
  • This study is for patients age 1 to 30.

For more information about this study and to inquire about eligibility, please contact Dr. Neerav Shukla at 212-639-5158.

Protocol

19-127

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators