Last updated on August 2019

A Study of ASP2215 (Gilteritinib) by Itself ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy


Are you eligible to participate in this study?

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

  • Conditions: Acute myeloid leukemia | Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Subject is considered an adult according to local regulation at the time of obtaining informed consent.
  • Subject has a diagnosis of previously-untreated AML according to World Health Organization (WHO) classification [Swerdlow et al, 2008] as determined by pathology review at the treating institution.
  • Subject is positive for FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD] [D835/I836] mutation) (or for Korea only: ITD alone or ITD with concurrent TKD activating mutation) in bone marrow or whole blood as determined by central laboratory. Note: Only applicable to the randomization portion.
  • Subject is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:
    1. Subject is 75 years of age.
    2. Subject has any of the following comorbidities:
  • Congestive heart failure (New York Heart Association {NYHA} class 3) or ejection fraction (Ef) 50%;
  • Creatinine > 2 mg/dL (177 mol/L), dialysis or prior renal transplant;
  • ECOG performance status 2;
  • Known pulmonary disease with decreased diffusion capacity of lung for carbon monoxide (DLCO) and/or requiring oxygen 2 liters per minute
  • Prior or current malignancy that does not require concurrent treatment;
  • Subject has received a cumulative anthracycline dose above 400 mg/m2 of doxorubicin (or cumulative maximum dose of another anthracycline).
  • Subject must meet the following criteria as indicated on the clinical laboratory
    tests
  • Serum AST and ALT 2.5 x Institutional upper limit of normal (ULN)
  • Serum total bilirubin 1.5 x Institutional ULN
  • Serum potassium Institutional lower limit of normal (LLN)
  • Serum magnesium Institutional LLN
  • Subject is suitable for oral administration of study drug.
  • Female subject is eligible to participate if female subject is not pregnant and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP); OR
  • WOCBP agrees to follow the contraceptive guidance starting at screening and continue throughout the study period, and for at least 180 days after the final study drug administration.
  • Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 60 days after the final study drug administration.
  • Female subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration.
  • Male subject with female partners of childbearing potential must agree to use contraception as detailed in Contraception Requirements, starting at screening and continue throughout the study period, and for 120 days after the final study drug administration.
  • Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.
  • Subject agrees not to participate in another interventional study while on treatment.

Exclusion Criteria:

  • Subject was diagnosed as acute promyelocytic leukemia (APL).
  • Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
  • Subject has received previous therapy for AML, with the exception of the following:
  • Emergency leukapheresis
  • Hydroxyurea
  • Preemptive treatment with retinoic acid prior to exclusion of APL 7 days
  • Growth factor or cytokine support
  • Steroids
  • Subject has clinically active central nervous system leukemia.
  • Subject has been diagnosed with another malignancy that requires concurrent treatment (with the exception of hormone therapy) or hepatic malignancy regardless of need for treatment.
  • Subject has clinically significant coagulation abnormality unless secondary to AML.
  • Subject has had major surgery within 4 weeks prior to the first study dose.
  • Subject has radiation therapy within 4 weeks prior to the first study dose.
  • Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 CYP3A.
  • Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-gp with the exception of drugs that are considered absolutely essential for the care of the subject.
  • Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.
  • Subject has congestive heart failure classified as New York Heart Association Class IV.
  • Subject with mean Fridericia-corrected QT interval (QTcF) > 450 ms at screening based on central reading.
  • Subject with a history of Long QT Syndrome at screening.
  • Subject has known pulmonary disease with diffusion capacity of lung for carbon monoxide (DLCO) 50%, forced expiratory volume in the first second (FEV1) 60%, dyspnea at rest or requiring oxygen or any pleural neoplasm (Transient use of supplemental oxygen is allowed.)
  • Subject has an active uncontrolled infection. If an infection is present, the patient must be receiving definitive therapy and have no signs of progressing infection. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
  • Subject is known to have human immunodeficiency virus infection.
  • Subject has active hepatitis B or C or other active hepatic disorder.
  • Subject has any condition which makes the subject unsuitable for study participation, including any contraindications of azacitidine.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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