A Phase I Study of Blinatumomab in Children and Adolescents with Relapsed/Refractory Acute Lymphoblastic Leukemia

Protocol
12-044
Full Title
A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)(MT103-205)(COG AALL1121)
Phase
I/II
Disease Status
Newly Diagnosed & Relapsed/Refractory
Purpose

The purpose of this study is to find the highest dose of an investigational drug called blinatumomab that can be used safely in children and adolescents with acute lymphoblastic leukemia (ALL) that has returned despite or stopped responding to standard therapy.

Blinatumomab is an antibody called a “bi-specific T-cell engager (BiTE).” It attaches to a protein on leukemia cells and also to white blood cells called T cells. When a cancer cell and a T cell are brought together by blinatumomab, the T cell can kill the cancer cell.

Blinatumomab 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 be age 18 or less.
  • Patients must have B-precursor ALL that has returned despite or stopped responding to standard therapy.
  • At least 2 weeks must have passed since completion of prior chemotherapy, 4 weeks since radiation therapy, and 6 weeks since immunotherapy and entry into the study.

For more information about this study and to inquire about eligibility, please contact Dr. Tanya Trippett at 212-639-8267.

Disease(s)
Leukemia
Leukemia: Acute Lymphoblastic Leukemia
Locations
Related Diseases