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

28. mai 2026 oppdatert av: 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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

6

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Japan
      • Chiba, Japan
        • Rekruttering
        • Chiba Aoba Municipal Hospital
      • Gifu, Japan
        • Rekruttering
        • Gifu Municipal Hospital
      • Hyōgo, Japan
        • Har ikke rekruttert ennå
        • Hyogo Medical University Hospital
      • Ibaraki, Japan
        • Rekruttering
        • Mito Medical Center
      • Kagoshima, Japan
        • Rekruttering
        • Imamura General Hospital
      • Kanagawa, Japan
        • Rekruttering
        • Kanagawa Cancer Center
      • Kyoto, Japan
        • Har ikke rekruttert ennå
        • Kyoto University Hospital
      • Miyagi, Japan
        • Rekruttering
        • Tohoku University Hospital
      • Nagano, Japan
        • Rekruttering
        • Matsumoto National Hospital
      • Nagasaki, Japan
        • Rekruttering
        • Nagasaki University Hospital
      • Okayama, Japan
        • Rekruttering
        • Okayama University Hospital
      • Okayama, Japan
        • Rekruttering
        • Kurashiki Central Hospital
      • Osaka, Japan
        • Rekruttering
        • Osaka Metropolitan university Hospital
      • Osaka, Japan
        • Rekruttering
        • Kansai Medical University Hospital
      • Saitama, Japan
        • Har ikke rekruttert ennå
        • Jichi Medical University Saitama Medical Center
      • Tochigi, Japan
        • Rekruttering
        • Dokkyo Medical University Hospital
      • Tochigi, Japan
        • Rekruttering
        • Jichi Medical University Hospital
      • Tokyo, Japan
        • Rekruttering
        • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
      • Tokyo, Japan
        • Har ikke rekruttert ennå
        • Keio University Hospital
      • Tokyo, Japan
        • Har ikke rekruttert ennå
        • Nippon Medical School Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: ziftomenib
Oral adminitration once daily
Legemiddel: ziftomenib
Oral adminitration once daily

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
CR+CRh rate
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
MRD-negative CR+CRh (CR+CRhMRD-) rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: During the treatment
During the treatment
Discontinuation of ziftomenib due to adverse events
Tidsramme: During the treatment
During the treatment
Clinically significant changes in clinical laboratory values, vital signs, and ECG parameters
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kyowa Kirin Co., Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. april 2026

Primær fullføring (Antatt)

1. mars 2027

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

8. april 2026

Først innsendt som oppfylte QC-kriteriene

28. mai 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KO-MEN-J001
  • jRCT2031250550 (Registeridentifikator: jRCT)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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