Risk-Stratified Randomized Phase III Testing of Blinatumomab in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

Conditions

Leukemia, not otherwise specified | Pediatrics

Phase III

What is the purpose of this trial?

Primary Aims

  • To compare disease free survival (DFS) of HR and IR relapse 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).
  • To compare DFS of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization).

Secondary Aims

  • To compare overall survival (OS) of HR and IR relapse 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).
  • To compare OS of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization).

Exploratory Aims

  • To compare the rates of MRD ¡Ý 0.01% at the end of Block 2 and Block 3 for HR and IR relapse B-ALL patients in HR/IR randomization.
  • Trial with
    Children's Oncology Group (The)
  • Start Date
    10/28/2015
  • End Date
    01/31/2020

I'm interested in volunteering

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 877.978.8348

Trial Image

For more information about this study, contact:

Sharon Huie

  • Last Updated
    06/22/2018
  • Study HIC
    #1501015261