EUCTR2015-001790-41-FR
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
Astellas Pharma Global Development, Inc. (APGD)0 sites1,803 target enrollmentJune 28, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ewly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy
- Sponsor
- Astellas Pharma Global Development, Inc. (APGD)
- Enrollment
- 1803
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Institutional Review Board (IRB)\-/Independent Ethics Committee (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.
- •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 or ejection fraction (Ef) \= 50%;
- •ii. Creatinine \> 2 mg/dL (177 µmol/L), dialysis or prior renal transplant;
- •iii. ECOG performance status \= 3;
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 for \= 14 days
- •? Preemptive treatment with retinoic acid prior to exclusion of APL \= 7 days
- •? Growth factor or cytokine support
- •? Steroids for the treatment of hypersensitivity or transfusion reactions
- •4\. Subject has clinically active central nervous system leukemia.
- •5\. Subject has been diagnosed with another malignancy that requires concurrent treatment or hepatic malignancy regardless of need for treatment.
Outcomes
Primary Outcomes
Not specified
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