EUCTR2015-001790-41-IT
Active, not recruiting
Phase 1
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 with FLT3 Mutation inPatients Not Eligible for Intensive Induction Chemotherapy -
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.
- Enrollment
- 1803
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Institutional Review Board \-/Independent Ethics Committee (IRB / IEC) \-approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act \[HIPAA] Authorization for United States \[US] sites) must be obtained from the subject or legally authorized representative prior to any study\-related procedures (including withdrawal of prohibited medication, if applicable).
- •2\. Subject is considered an adult according to local regulation at the time of obtaining informed consent.
- •3\. 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.
- •4\. Subject is positive for FLT3 mutation (ITD or TKD \[D835/I836] mutation) in bone marrow or whole blood as determined by central laboratory. NOTE: Only applicable to the randomization portion of the study.
- •5\. Subject is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:
- •a. Subject is \= 75 years of age.
- •b. Subject has any of the following comorbidities:
- •i. Congestive heart failure (New York Heart Association (NYHA) class \= 3\) or ejection fraction (EF) \= 50%;
- •ii. Creatinine \> 2 mg/dL (177 µmol/L), dialysis or prior renal transplant;
- •iii. ECOG performance status \= 2;
Exclusion Criteria
- •1\. Subject was diagnosed as acute promyelocytic leukemia (APL).
- •2\. Subject has BCR\-ABL\-positive leukemia (chronic myelogenous leukemia in blast crisis).
- •3\. 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
- •4\. Subject has clinically active central nervous system leukemia.
- •5\. 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.
- •6\. Subject has clinically significant coagulation abnormality unless secondary to AML in the opinion of the investigator.
Outcomes
Primary Outcomes
Not specified
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