Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)
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).
The purpose of this study is to compare disease free survival (DFS) of high-risk (HR) and intermediate-risk (IR) relapse B-cell acute lymphoblastic leukemia (B-ALL) patients who are randomized following induction block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR randomization), and to compare the DFS of low risk (LR) relapse B-ALL patients who are randomized following block 2 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR randomization).
- IRB Number: 1412140923 (PHO-COG-FALLON-AALL1331)
- Research Study Identifier: TX4663
- Principal Investigator: Batra Sandeep, MD