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

2026年5月28日 更新者：Kyowa Kirin Co., Ltd.

A Phase 2, Multicenter, Open-Label Study of Ziftomenib Monotherapy in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia With NPM1 Mutation

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

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

6

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 日本
      • Chiba、日本
        • 招聘中
        • Chiba Aoba Municipal Hospital
      • Gifu、日本
        • 招聘中
        • Gifu Municipal Hospital
      • Hyōgo、日本
        • 尚未招聘
        • Hyogo Medical University Hospital
      • Ibaraki、日本
        • 招聘中
        • Mito Medical Center
      • Kagoshima、日本
        • 招聘中
        • Imamura General Hospital
      • Kanagawa、日本
        • 招聘中
        • Kanagawa Cancer Center
      • Kyoto、日本
        • 尚未招聘
        • Kyoto University Hospital
      • Miyagi、日本
        • 招聘中
        • Tohoku University Hospital
      • Nagano、日本
        • 招聘中
        • Matsumoto National Hospital
      • Nagasaki、日本
        • 招聘中
        • Nagasaki University Hospital
      • Okayama、日本
        • 招聘中
        • Okayama University Hospital
      • Okayama、日本
        • 招聘中
        • Kurashiki Central Hospital
      • Osaka、日本
        • 招聘中
        • Osaka Metropolitan university Hospital
      • Osaka、日本
        • 招聘中
        • Kansai Medical University Hospital
      • Saitama、日本
        • 尚未招聘
        • Jichi Medical University Saitama Medical Center
      • Tochigi、日本
        • 招聘中
        • Dokkyo Medical University Hospital
      • Tochigi、日本
        • 招聘中
        • Jichi Medical University Hospital
      • Tokyo、日本
        • 招聘中
        • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
      • Tokyo、日本
        • 尚未招聘
        • Keio University Hospital
      • Tokyo、日本
        • 尚未招聘
        • Nippon Medical School Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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 0-2.
  • 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.

Exclusion Criteria:

  • 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 1.
  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：ziftomenib
Oral adminitration once daily
药品：ziftomenib
Oral adminitration once daily

研究衡量的是什么？

主要结果指标

结果测量
大体时间
CR+CRh rate
大体时间：Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks

次要结果测量

结果测量
措施说明
大体时间
MRD-negative CR+CRh (CR+CRhMRD-) rate
大体时间：Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
CR rate
大体时间：Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
MRD-negative CR rate
大体时间：Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
CRc (CR+ CRh + CRi) rate
大体时间：Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
MRD-negative CRc (CRcMRD-) rate
大体时间：Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
ORR (CR + CRh + CRi + MLFS + PR)
大体时间：Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Best overall response assessed every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Transfusion independence rate
大体时间：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
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
Duration of CR+CRh
大体时间：Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Time to CR+CRh
大体时间：Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Time to CR
大体时间：Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Time to CRc
大体时间：Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Time to CR, CRh, Cri, MLFS or PR
大体时间：Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
EFS
大体时间：Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
Every 28 days from first dose until disease progression or withdrawall, an average of 16weeks
OS
大体时间：During the treatment and every 90 days after study treatment completion (approximately up to 1 year after study treatment completion)
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
大体时间：During treatment and up to approximately 28 days after treatment discontinuation
During treatment and up to approximately 28 days after treatment discontinuation
Incidence of serious adverse events
大体时间：During treatment and up to approximately 28 days after treatment discontinuation
During treatment and up to approximately 28 days after treatment discontinuation
Death during treatment with ziftomenib
大体时间：During the treatment
During the treatment
Discontinuation of ziftomenib due to adverse events
大体时间：During the treatment
During the treatment
Clinically significant changes in clinical laboratory values, vital signs, and ECG parameters
大体时间：During treatment and up to end of the treatment assessment
During treatment and up to end of the treatment assessment
Clinically significant decrease in ECOG PS
大体时间：During treatment and up to end of the treatment assessment
During treatment and up to end of the treatment assessment
Area under the plasma drug concentration time curve over a dosing interval (AUC0-τ)
大体时间：Cycle 1 Day 1, and Cycle 2 Day 1 (each cycle is 28 days)
AUC0-τ of ziftomenib and its metabolites
Cycle 1 Day 1, and Cycle 2 Day 1 (each cycle is 28 days)
Maximum plasma concentration (Cmax)
大体时间：Cycle 1 Day 1, and Cycle 2 Day 1 (each cycle is 28 days)
Cmax of ziftomenib and its metabolites
Cycle 1 Day 1, and Cycle 2 Day 1 (each cycle is 28 days)
Time to observed maximum plasma concentration (Tmax)
大体时间：Cycle 1 Day 1, and Cycle 2 Day 1 (each cycle is 28 days)
Tmax of ziftomenib and its metabolites
Cycle 1 Day 1, and Cycle 2 Day 1 (each cycle is 28 days)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Kyowa Kirin Co., Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月23日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年4月8日

首先提交符合 QC 标准的

2026年5月28日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月28日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • KO-MEN-J001
  • jRCT2031250550 (注册表标识符：jRCT)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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