test

(E1910) A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults

Conditions

Leukemia, other

What is the purpose of this trial?

Primary Objectives - To compare the overall survival (OS) of blinatumomab in conjunction with chemotherapy to chemotherapy alone in patients with BCR-ABL-negative B cell precursor ALL who are MRD positive after induction and intensification chemotherapy, based on multiparameter flow cytometric (MFC) assessment of residual blasts. - If superiority of blinatumomab in the MRD positive group is shown, to compare the OS of blinatumomab in conjunction with chemotherapy to chemotherapy alone in patients with BCR-ABL-negative B cell precursor ALL who are MRD negative after induction and intensification chemotherapy, based on MFC assessment of residual blasts. - If superiority of blinatumomab in the MRD positive group is not shown, to compare the OS of blinatumomab in conjunction with chemotherapy to chemotherapy alone in the overall population of patients with BCR-ABL-negative B cell precursor ALL. Secondary Objectives - To determine if blinatumomab can convert patients who are MRD positive by MFC assessment of residual blasts after induction and intensification chemotherapy to MRD negativity. - To assess the toxicities of blinatumomab in this patient population - To assess the toxicities of the modified E2993 chemotherapy regimen in this patient population. - To describe the outcome of patients who proceed to allogeneic blood or marrow transplant after treatment with or without blinatumomab. Laboratory Objectives - To determine differences in MRD kinetics among patients with the BCR/ABL1-like B-lineage ALL, and assess the efficacy of blinatumomab in each molecular subgroup. - To evaluate the incidence of anti-blinatumomab antibody response.

Participation Guidelines

Age:
Gender:

Click here for detailed information about who can participate in this trial.


Sponsor:
Eastern Cooperative Oncology Group
Dates:
04/16/2015
Last Updated:
Study HIC#:
1402013426