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

28 maj 2026 uppdaterad 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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

6

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: ziftomenib
Oral adminitration once daily
Läkemedel: ziftomenib
Oral adminitration once daily

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
CR+CRh rate
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Kyowa Kirin Co., Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

23 april 2026

Primärt slutförande (Beräknad)

1 mars 2027

Avslutad studie (Beräknad)

1 december 2028

Studieregistreringsdatum

Först inskickad

8 april 2026

Först inskickad som uppfyllde QC-kriterierna

28 maj 2026

Första postat (Faktisk)

3 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

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