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

ConditionAcute Myeloid Leukemia (AML)
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • ziftomenib

    Drug

    Oral adminitration once daily

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: ziftomenibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CR+CRh rate

Time frame
Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks

Secondary outcomes

1

MRD-negative CR+CRh (CR+CRhMRD-) rate

Time frame
Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
2

CR rate

Time frame
Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
3

MRD-negative CR rate

Time frame
Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
4

CRc (CR+ CRh + CRi) rate

Time frame
Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kyowa Kirin Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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