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

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

Primary Objectives
2.1.1 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.
2.1.2 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.
2.1.3 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.
2.2 Secondary Objectives
2.2.1 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.
2.2.2 To assess the toxicities of blinatumomab in this patient population
2.2.3 To assess the toxicities of the modified E2993 chemotherapy regimen in this patient population.
2.2.4 To describe the outcome of patients who proceed to allogeneic blood or marrow transplant after treatment with or without blinatumomab.
2.3 Laboratory Objectives
2.3.1 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.
2.3.2 To evaluate the incidence of anti-blinatumomab antibody formation.

Protocol Number: 021402
Phase: Phase III
Applicable Disease Sites: Leukemia, other
Leukemia, not otherwise specified
Drugs Involved: 6-MERCAPTOPURINE
PEG Asparaginase (PEG)
DEXAMETHASONE
ETOPOSIDE
VINCRISTINE
Blinatumomab (AMG103)
DAUNORUBICIN
CYCLOPHOSPHAMIDE
METHOTREXATE
CYTARABINE
LEUCOVORIN
Principal Investigator: Dale Schaar
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Bone Marrow Transplant
Chemotherapy multiple agents systemic
Participating Institutions: Rutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@cinj.rutgers.edu.

 

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