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

28 de maio de 2026 atualizado por: 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

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

6

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Japão
      • Chiba, Japão
        • Recrutamento
        • Chiba Aoba Municipal Hospital
      • Gifu, Japão
        • Recrutamento
        • Gifu Municipal Hospital
      • Hyōgo, Japão
        • Ainda não está recrutando
        • Hyogo Medical University Hospital
      • Ibaraki, Japão
        • Recrutamento
        • Mito Medical Center
      • Kagoshima, Japão
        • Recrutamento
        • Imamura General Hospital
      • Kanagawa, Japão
        • Recrutamento
        • Kanagawa Cancer Center
      • Kyoto, Japão
        • Ainda não está recrutando
        • Kyoto University Hospital
      • Miyagi, Japão
        • Recrutamento
        • Tohoku University Hospital
      • Nagano, Japão
        • Recrutamento
        • Matsumoto National Hospital
      • Nagasaki, Japão
        • Recrutamento
        • Nagasaki University Hospital
      • Okayama, Japão
        • Recrutamento
        • Okayama University Hospital
      • Okayama, Japão
        • Recrutamento
        • Kurashiki Central Hospital
      • Osaka, Japão
        • Recrutamento
        • Osaka Metropolitan university Hospital
      • Osaka, Japão
        • Recrutamento
        • Kansai Medical University Hospital
      • Saitama, Japão
        • Ainda não está recrutando
        • Jichi Medical University Saitama Medical Center
      • Tochigi, Japão
        • Recrutamento
        • Dokkyo Medical University Hospital
      • Tochigi, Japão
        • Recrutamento
        • Jichi Medical University Hospital
      • Tokyo, Japão
        • Recrutamento
        • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
      • Tokyo, Japão
        • Ainda não está recrutando
        • Keio University Hospital
      • Tokyo, Japão
        • Ainda não está recrutando
        • Nippon Medical School Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: ziftomenib
Oral adminitration once daily
Medicamento: ziftomenib
Oral adminitration once daily

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
CR+CRh rate
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
MRD-negative CR+CRh (CR+CRhMRD-) rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: During the treatment
During the treatment
Discontinuation of ziftomenib due to adverse events
Prazo: During the treatment
During the treatment
Clinically significant changes in clinical laboratory values, vital signs, and ECG parameters
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Kyowa Kirin Co., Ltd.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

23 de abril de 2026

Conclusão Primária (Estimado)

1 de março de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

8 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de maio de 2026

Primeira postagem (Real)

3 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • KO-MEN-J001
  • jRCT2031250550 (Identificador de registro: jRCT)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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