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  • A 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

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • EA9181
    NCT ID
    • NCT04530565
    Age Group
    • Adult
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase III
    Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
    • Phase III
    Principal Investigator
    • Jay
      Yang, M.D.

      Oncology - Hematology, Oncology - Medical View Profile


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

    Secondary Objectives:
    • To compare the rate of MRD negativity for patients treated with chemotherapy vs blinatumomab at the end of first induction (week 15).
    • 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.
  • Locations


    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266