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Ziftomenib Monotherapy in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia With NPM1 Mutation
NCT07623616Phase 2
Key facts
- Status
- Recruiting
- Start
- Apr 2026
- Primary completion
- Mar 2027
- Countries
- 1
- Sponsor
- Kyowa Kirin
- Drugs
- ziftomenib
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 2, open-label, single-arm trial of ziftomenib in acute myeloid leukemia (AML), sponsored by Kyowa Kirin. Primary endpoint: Complete Remission + Complete Remission with Partial Hematologic Recovery Rate. Started Apr 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
ziftomenib
Oral administration once daily
03
Who it enrols
Adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, ECOG PS 0-2, adequate organ function, no prior menin inhibitor treatment, and no active CNS leukemia.
04
Endpoints
Primary
Complete Remission + Complete Remission with Partial Hematologic Recovery Rate
Secondary
Measurable Residual Disease-negative Complete Remission + Complete Remission with Partial Hematologic Recovery Rate
Complete Remission Rate
Measurable Residual Disease-negative Complete Remission Rate
Composite Complete Remission Rate
Measurable Residual Disease-negative Composite Complete Remission Rate
Overall Response Rate
Transfusion Independence Rate
Duration of Complete Remission + Complete Remission with Partial Hematologic Recovery
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