JPRN-jRCT2080223386
Completed
Phase 2
Phase 2 open-label, single-arm study of Quizartinib (AC220) monotherapy in Japanese patients with FLT3-ITD positive refractory or relapsed acute myeloid leukemia
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Enrollment
- 37
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Treatment with quizartinib monotherapy was well tolerated and resulted in clinically meaningful reductions in blast count in Japanese patients with FLT3-ITD positive relapsed or refractory AML.
Investigators
Eligibility Criteria
Inclusion Criteria
- •AML patients in first relapse or refractory after all prior therapy.
- •\-Presence of the FLT3\-ITD activating mutation in bone marrow or peripheral blood.
- •\-ECOG Performance Status(PS) of 0 to 2\.
Exclusion Criteria
- •\-Diagnosis of acute promyelocytic leukemia.
- •\-AML secondary to prior chemotherapy for other neoplasms.
- •\-Persistent, clinically significant \> Grade 1 non\-hematologic toxicity from prior AML therapy.
- •\-Prior treatment with a FLT3 targeted therapy.
- •\-Active infection not well controlled by antibacterial, antifungal and/or antiviral therapy.
Outcomes
Primary Outcomes
Not specified
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