2215-CL-0201 (FL)

A Phase 2/3 Multicenter, Open-label, 3-arm, 2-Stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy

Study Treatments

• Safety cohort: ASP2215 daily (days 1-28) and azacitidine daily for 7 days (days 1-7)
• Arm A: ASP2215 daily each 28-day cycle
• Arm AC: ASP2215 daily and azacitidne daily for 7 days (days 1-7) each 28-day cycle
• Arm C: azacitidine for 7 days (days 1-7) each 28-day cycle

Inclusion criteria

• Diagnosis of previously-untreated AML according to WHO classification
• Positive for FLT3 mutation  in bone marrow or whole blood as determined by central laboratory
• Subject is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:
  • Subject is ≥ 75 years of age
  • Subject has any of the following comorbidities:
    • Congestive heart failure (NYHA class ≤ 3) or ejection fraction ≤ 50%
    • Creatinine > 2 mg/dL, dialysis or prior renal transplant
    • ECOG  ≥ 2
    • Known pulmonary disease with decreased diffusion capacity of lung for carbon monoxide 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)

Exclusion criteria

• Acute promyelocytic leukemia (APL)
• BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis)
•  Clinically active central nervous system leukemia

Participating sites

• Ghent University Hospital 
• UZ Brussel
• Cliniques Universitaires UCL Saint Luc