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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

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

6

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • 日本
      • Chiba、日本
        • 募集
        • Chiba Aoba Municipal Hospital
      • Gifu、日本
        • 募集
        • Gifu Municipal Hospital
      • Hyōgo、日本
        • まだ募集していません
        • Hyogo Medical University Hospital
      • Ibaraki、日本
        • 募集
        • Mito Medical Center
      • Kagoshima、日本
        • 募集
        • Imamura General Hospital
      • Kanagawa、日本
        • 募集
        • Kanagawa Cancer Center
      • Kyoto、日本
        • まだ募集していません
        • Kyoto University Hospital
      • Miyagi、日本
        • 募集
        • Tohoku University Hospital
      • Nagano、日本
        • 募集
        • Matsumoto National Hospital
      • Nagasaki、日本
        • 募集
        • Nagasaki University Hospital
      • Okayama、日本
        • 募集
        • Okayama University Hospital
      • Okayama、日本
        • 募集
        • Kurashiki Central Hospital
      • Osaka、日本
        • 募集
        • Osaka Metropolitan university Hospital
      • Osaka、日本
        • 募集
        • Kansai Medical University Hospital
      • Saitama、日本
        • まだ募集していません
        • Jichi Medical University Saitama Medical Center
      • Tochigi、日本
        • 募集
        • Dokkyo Medical University Hospital
      • Tochigi、日本
        • 募集
        • Jichi Medical University Hospital
      • Tokyo、日本
        • 募集
        • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
      • Tokyo、日本
        • まだ募集していません
        • Keio University Hospital
      • Tokyo、日本
        • まだ募集していません
        • Nippon Medical School Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：ziftomenib
Oral adminitration once daily
薬：ziftomenib
Oral adminitration once daily

この研究は何を測定していますか？

主要な結果の測定

結果測定
時間枠
CR+CRh rate
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
MRD-negative CR+CRh (CR+CRhMRD-) rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：During the treatment
During the treatment
Discontinuation of ziftomenib due to adverse events
時間枠：During the treatment
During the treatment
Clinically significant changes in clinical laboratory values, vital signs, and ECG parameters
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Kyowa Kirin Co., Ltd.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月23日

一次修了 (推定)

2027年3月1日

研究の完了 (推定)

2028年12月1日

試験登録日

最初に提出

2026年4月8日

QC基準を満たした最初の提出物

2026年5月28日

最初の投稿 (実際)

2026年6月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月3日

QC基準を満たした最後の更新が送信されました

2026年5月28日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • KO-MEN-J001
  • jRCT2031250550 (レジストリ識別子：jRCT)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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