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  • A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML.

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • BMTCTN1506
    NCT ID
    • NCT02997202
    Age Group
    • Adult
    Scope
    • 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
    • Abhinav
      Deol, M.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Primary:
    The primary objective is to compare relapse-free survival (RFS) between participants with FL T3/1TD AML in CR! who undergo HCT and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.
    Secondary:
    1. To detennine the safety and tolerability of gilteritinib after HCT.
    2. To compare overall survival (OS), non-relapse mortality (NRM) and event-free survival (EFS) (where events include relapse, death, stopping therapy and administration of donor lymphocyte infusion (DLI) or new therapy for suspicion of disease) in participants treated with gilteritinib as maintenance therapy after HCT compared to those treated with placebo.
    3. To compare 6-month cumulative incidence of grades II-IV and III­IV acute graft-versus-host disease (GVHD) and 12-month and 24- month cumulative incidence of mild, moderate, and severe GVHD in participants treated with gilteritinib as maintenance therapy after HCT compared to those treated with placebo.
    4. To examine the effect of pre- and post-transplant MRD on RFS and OS.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

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