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Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia


Title Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND#117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)
Therapeutic Area Leukemias (Pediatric)
Principal Investigator Michael Kelly, MD
Min Age 1 Years
Max Age 31 Years
Gender Both
Contact Jennifer Truong
617-6366-8885
More Information https://clinicaltrials.gov/ct2/show/NCT02101853

Overview

This randomized phase III trial compares how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, can block cancer growth by finding cancer cells and helping to kill them or carrying cancer-killing substances to them. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.

Study Details

Inclusion Criteria

  • First relapse of B-cell acute lymphoblastic leukemia
  • Otherwise normal organ function

Exclusion Criteria

  • No prior exposure to blinatumomab
  • No pregnant or nursing females
  • No complicating malignancies or diseases

Study Requirements

Subjects on this study will come to the hospital for clinic visits and have scans, radiation therapy, and/or chemotherapy as they would if they were not in the study. Some subjects will be randomized to receive either standard chemotherapy or standard chemotherapy plus the study drug blinatumomab