A PHASE 1 STUDY OF MILADEMETAN IN COMBINATION WITH QUIZARTINIB IN SUBJECTS WITH FLT3-ITD MUTANT ACUTE MYELOID LEUKEMIA THAT ARE RELAPSED/REFRACTORY OR NEWLY DIAGNOSED AND UNFIT FOR INTENSIVE CHEMOTHERAPY

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Myeloid Leukaemia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects with FLT3-ITD mutant (> 3% FLT3-ITD/total FLT3) AML (primary AML or secondary to MDS) that have failed any prior induction therapy regimen or have relapsed after prior induction/consolidation therapy and had not received more than 3 prior salvage therapies. 2.Has adequate renal function, defined as creatinine clearance = 60 mL/min, as calculated using the modified Cockcroft-Gault equation ([{140 – age in years} × {actual weight in kg}] divided by [{72 ×serum creatinine in mg/dL} multiply by 0.85 if female]). 3. Discontinuation of prior AML treatment before the start of study treatment (except hydroxyurea to control leukocytosis) for at least 2 weeks for cytotoxic agents, or for at least 5 half-lives for non-cytotoxic agents. Hydroxyurea is allowed until 48 hours prior to start of the study treatment.

You may not be eligible for this study if the following are true:

  • 1. Presence of central nervous system (CNS) involvement of leukemia. Patients with a history of CNS leukemia may be eligible if the CNS leukemia is adequately controlled (defined as no active clinical symptoms of CNS disease and at least 2 consecutive lumbar punctures with no evidence of disease prior to study enrollment) after discussion and approval from the Sponsor. 2) Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals. 3) Clinically significant graft versus host disease (GVHD) or GVHD requiring initiation of treatment or treatment escalation within 21 days prior to Screening, and/or > Grade 1 persistent or clinically significant non-hematologic toxicity related to HSCT.


If you are registered as a volunteer, please login to the dashboard to send referrals.