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Protocol No. BMTCTN1506

Principal Investigator Hall, Aric

Phase III

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

Title 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

Objective The main purpose of this study is to learn if it is safe and effective (works well) to treat patients who have FLT3/ITD AML with a study drug called gilteritinib (ASP2215) after transplant. We want to know if this drug works better than a placebo (pill that contains no drug, like a sugar pill) to stop the AML from coming back. (Definitions of bolded terms are in the next section.) The FDA (U.S. Food and Drug Administration) has not approved the use of Gilteritinib for the treatment of AML, therefore this drug is considered investigational for this study.

Treatment
Randomized into two groups:
  • Group A (gilteritinib) OR
  • Group B (placebo)
  • You have an equal chance of getting the gilteritinib or placebo. It is just like flipping a coin.

  • Description Randomized, double-blind, placebo controlled study of FLT3 inhibitor Gilteritinib versus placebo

    Key Eligibility
  • Participant is considered a suitable candidate for HCT and has an acceptable source of allogeneic donor cells, as defined per institutional practice (allogeneic HCT for any donor source [matched sibling, unrelated donor (URD), mismatched URD, related haploidentical, or umbilical cord blood] and any graft source [umbilical cord, BM, peripheral blood (PB)], and any conditioning [myeloablative conditioning (MAC), reduced intensity conditioning (RIC), or non-myeloablative conditioning (NMA)] will be permitted)
  • Participant consents to allow access to his or her diagnostic BM aspirate or PB sample and/or the DNA derived from that sample, if available, that may be used to validate a companion diagnostic that is being developed in parallel with gilteritinib
  • Participant has confirmed, morphologically documented AML in CR1
  • Participant has presence of the FLT3/ITD activating mutation in the BM or PB
  • Must have adequate renal and liver function
  • Participant has left ventricular ejection fraction (LVEF) at rest ≥ 40%
  • Male and Female patients of childbearing potential must use adequate birth control
  • Can not be pregnant or breastfeeding Must have a Karnofsky performance status score > 70%
  • Must have a Fridericia-corrected QT interval (QTcF) < 450 msec
  • No known infection with human immunodeficiency virus (HIV)
  • No myocardial infarction within the past 6 months
  • No prior malignancies, except lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed

  • Applicable Disease Sites Leukemia

    Status Open

    Participating Institutions UW Hospital and Clinics