A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKyowa Kirin Co., Ltd.

About this trial

This is the first study to administer ziftomenib to Japanese patients. In this study, the efficacy, safety, and pharmacokinetics of ziftomenib will be evaluated in patients with relapsed or refractory NPM1-mutated acute myeloid leukemia

Eligibility criteria

Qualifiers

Voluntary written informed consent and willingness to comply with all study procedures

Age ≥ 18 years

Confirmed diagnosis of acute myeloid leukemia (AML)

Patients with R/R AML with NPM1-m

Disqualifiers

Diagnosis of acute promyelocytic leukemia.

Donor lymphocyte infusion < 30 days prior to study entry.

Clinically active central nervous system (CNS) leukemia.

Prior hematopoietic stem cell transplantation (HSCT) without adequate hematologic recovery.

Trial design

Treatments tested in this trial

  • ziftomenib

Treatment groups

6 Participants
are divided into 1 treatment group

Sponsors and collaborators