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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
More Information


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