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Phase III Randomized Trial of Steroids +Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-positive Acute Lymphoblastic Leukemia in Adults.

Objectives
Primary Endpoints:
- To compare the overall survival (OS) following induction with steroids + TKI + blinatumomab versus induction with steroids + TKI +chemotherapy.

Secondary Endpoints:
- To compare the rate of MRD negativity for patients treated with chemotherapy vs blinatumomab at the end of first induction (week15).

- To evaluate the rate of the MRD negativity by treatment arm for those patients MRD positive after the first induction and administered of second induction.

- To compare event free survival (EFS) for patients initially randomized for chemotherapy vs blinatumomab. (Events include failure to achieve induction molecular remission by week 15, confirmed molecular relapse after molecular remission or to death in remission).

- To assess the toxicities of blinatumomab+TKI and steroids + TKI + chemotherapy in this patient population.

- To assess the toxicities of the chemotherapy regimen in this patient population.

- To describe the outcome of patients who proceed to allogeneic stem cell transplant after treatment with blinatumomab+TKI only.

Protocol Number: 022101
Phase: Phase III
Applicable Disease Sites: Lymphoid Leukemia
Drugs Involved: Blinatumomab (AMG103)
DASATANIB
PREDNISONE
Principal Investigator: Neil Palmisiano
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

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