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A Phase 3 Multicenter, Open-label, 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 in Patients Not Eligible for Intensive Induction Chemotherapy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512474-98-00
Acronym
2215-CL-0201
Enrollment
63
Registered
2024-06-12
Start date
2016-11-07
Completion date
2024-10-16
Last updated
2024-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy

Brief summary

Primary Efficacy Endpoint: ● Overall Survival (OS)

Detailed description

Key Secondary Efficacy Endpoint: ● Event-free survival (EFS), Secondary Efficacy Endpoints: ● Best Response ● CR, CRc, CRh, CR/CRh ● Transfusion conversion rate; transfusion maintenance rate ● Leukemia-free survival (LFS) ● Duration of remission ● Patient-reported fatigue from BFI, Safety Endpoints: ● AEs ● Clinical laboratory (serum chemistry, hematology, coagulation and urinalysis) results ● Physical examinations ● Vital sign measurements ● ECGs ● ECOG performance scores

Interventions

DRUGVidaza 25 mg/ml powder for suspension for injection
DRUGGilteritinib

Sponsors

Astellas Pharma Global Development Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Primary Efficacy Endpoint: ● Overall Survival (OS)—

Secondary

MeasureTime frame
Key Secondary Efficacy Endpoint: ● Event-free survival (EFS), Secondary Efficacy Endpoints: ● Best Response ● CR, CRc, CRh, CR/CRh ● Transfusion conversion rate; transfusion maintenance rate ● Leukemia-free survival (LFS) ● Duration of remission ● Patient-reported fatigue from BFI, Safety Endpoints: ● AEs ● Clinical laboratory (serum chemistry, hematology, coagulation and urinalysis) results ● Physical examinations ● Vital sign measurements ● ECGs ● ECOG performance scores—

Countries

Belgium, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026