NCT07623616招募中2 期
A Phase 2, Multicenter, Open-Label Study of Ziftomenib Monotherapy in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia With NPM1 Mutation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 20
- 主要终点
- CR+CRh rate
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •No available standard of care expected to provide clinical benefit, ineligible for or declined standard therapy.
- •ECOG performance status 0-
- •White blood cell count ≤ 30,000/mm³ at screening (hydroxyurea permitted for cytoreduction).
- •Adequate organ function according to protocol requirements.
- •Women of childbearing potential must be willing to use a highly effective method of contraception throughout the study and for at least 187 days after the last dose of study treatment.
- •Males with female partners of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 97 days after the last dose of study treatment.
排除标准
- •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.
- •Active Grade ≥ 2 acute graft-versus-host disease or moderate/severe chronic graft-versus-host disease.
- •Prior treatment with a menin inhibitor.
- •Receipt of chemotherapy, immunotherapy, radiotherapy, or investigational therapy within 14 days or 5 half-lives prior to first dose.
- •Unresolved toxicities from prior therapy > Grade
- •Requirement for strong CYP3A4 inducers.
- •Active or uncontrolled infection, including hepatitis B, hepatitis C, or HIV.
- •Conditions predisposing to serious or life-threatening infection or significant immunodeficiency.
- •Cardiovascular disease or QTcF > 480 ms.
- •Interstitial lung disease.
- •Major surgery within 4 weeks prior to first dose.
- •Women who are pregnant or lactating
- •Any medical, psychiatric, or social condition that may interfere with study participation or safety, or that makes the patient unsuitable in the investigator's judgment.
研究组 & 干预措施
ziftomenib
Experimental
Oral adminitration once daily
干预措施: ziftomenib (Drug)
结局指标
主要结局
CR+CRh rate
时间窗: Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
次要结局
- Transfusion independence rate(From the day after first dose through the last dose before initiation of subsequent therapy (including hematopoietic stem cell transplantation)l, an average of 16weeks)
- Death during treatment with ziftomenib(During the treatment)
- CRc (CR+ CRh + CRi) rate(Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks)
- Time to CR(Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks)
- Discontinuation of ziftomenib due to adverse events(During the treatment)
- MRD-negative CRc (CRcMRD-) rate(Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks)
- Clinically significant changes in clinical laboratory values, vital signs, and ECG parameters(During treatment and up to end of the treatment assessment)
- ORR (CR + CRh + CRi + MLFS + PR)(Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks)
- Clinically significant decrease in ECOG PS(During treatment and up to end of the treatment assessment)
- Time to CRc(Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks)
- Duration of CR+CRh(Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks)
- Time to CR+CRh(Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks)
- MRD-negative CR+CRh (CR+CRhMRD-) rate(Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks)
- CR rate(Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks)
- MRD-negative CR rate(Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks)
- Time to CR, CRh, Cri, MLFS or PR(Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks)
- EFS(Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks)
- OS(During the treatment and every 90 days after study treatment completion (approximately up to 1 year after study treatment completion))
- Incidence and severity of adverse events(During treatment and up to approximately 28 days after treatment discontinuation)
- Incidence of serious adverse events(During treatment and up to approximately 28 days after treatment discontinuation)
- Area under the plasma drug concentration time curve over a dosing interval (AUC0-τ)(Cycle 1 Day 1, and Cycle 2 Day 1 (each cycle is 28 days))
- Maximum plasma concentration (Cmax)(Cycle 1 Day 1, and Cycle 2 Day 1 (each cycle is 28 days))
- Time to observed maximum plasma concentration (Tmax)(Cycle 1 Day 1, and Cycle 2 Day 1 (each cycle is 28 days))
研究者
研究点 (20)
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