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JNJ-75276617联合急性髓性白血病（AML）定向疗法的研究

2026年9月24日 更新者：Janssen Research & Development, LLC

JNJ-75276617 联合 AML 定向疗法治疗携带 KMT2A 或 NPM1 突变的急性髓系白血病患者的 1b 期研究

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2D(s) (dose expansion).

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

196

阶段

  • 阶段1

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。

学习地点

  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大、M5G 1Z5
        • Princess Margaret Cancer Centre University Health Network
  • 德国
      • Berlin、德国、13353
        • Charite Universitaetsmedizin Berlin
      • Dresden、德国、01307
        • Universitatsklinikum Carl Gustav Carus Dresden
      • Heidelberg、德国、69120
        • Universitaetsklinikum Heidelberg
      • Leipzig、德国、04103
        • Universitaetsklinikum Leipzig
      • Ulm、德国、89081
        • Universitatsklinikum Ulm
  • 意大利
      • Bologna、意大利、40138
        • Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
      • Meldola、意大利、47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milan、意大利、20162
        • ASST Grande Ospedale Metropolitano Niguarda
      • Rozzano、意大利、20089
        • IRCCS Istituto Clinico Humanitas
  • 法国
      • Marseille、法国、13273
        • Institut Paoli Calmettes
      • Rennes、法国、35033
        • Chu Rennes Hopital Pontchaillou
      • Toulouse、法国、31100
        • Institut Universitaire du Cancer Toulouse Oncopole
      • Tours、法国、37044
        • CHU de Tours - Hôpital de Bretonneau
  • 澳大利亚
      • Clayton、澳大利亚、3168
        • Monash Medical Centre
      • Melbourne、澳大利亚、3000
        • Peter MacCallum Cancer Centre
      • Westmead、澳大利亚、2145
        • Westmead Hospital
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35233
        • The University of Alabama at Birmingham
    • California
      • Duarte、California、美国、91010
        • City of Hope
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital
    • New York
      • New York、New York、美国、10461
        • Albert Einstein College Of Medicine
    • North Carolina
      • Charlotte、North Carolina、美国、28204
        • Novant Health
      • Winston-Salem、North Carolina、美国、27103
        • Novant Health Forsyth Medical Center
    • Texas
      • Houston、Texas、美国、77030
        • MD Anderson
  • 英国
      • London、英国、NW1 2PG
        • University College London Hospitals NHSFT
      • Manchester、英国、M20 4BX
        • Christie Hospital NHS Trust
      • Oxfordshire、英国、OX3 7LE
        • Oxford University Hospitals NHS Trust
  • 西班牙
      • Barcelona、西班牙、08041
        • Hosp. de La Santa Creu I Sant Pau
      • Barcelona、西班牙、08036
        • Hosp Clinic de Barcelona
      • Barcelona、西班牙、8035
        • Hosp Univ Vall D Hebron
      • Madrid、西班牙、28040
        • Hosp Univ Fund Jimenez Diaz
      • Pamplona、西班牙、31008
        • Clinica Univ. de Navarra

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

12年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adolescent participants (defined as greater than or equal to [>=] 12 and less than [<] 18 years of age) are only eligible for the relapsed/refractory (R/R) cohort (Arm A, cohort A4)
  • Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novo or secondary AML; b) relapsed/refractory (Arm A only); c) harboring KMT2A, NPM1, NUP98, or NUP214 alterations; d) Participants may receive emergency leukapheresis and/or cytarabine as cytoreductive therapy according to local practice guidelines
  • Pretreatment clinical laboratory values meeting the following criteria -listed below: White blood cell (WBC) count: less than or equal to (<=) 25*10^9 per liter (/L), adequate liver and renal function
  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Adolescent participants only: Performance status >70 by Lansky scale (for participants <16 years of age) or >70 Karnofsky scale (for participants >16 years of age)
  • A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
  • Must sign an informed consent form (ICF) indicating participant (or their legally authorized representative) understands the purpose of the study and procedures required for the study and is willing to participate in the study
  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria:

  • Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to WHO 2016 criteria
  • Leukemic involvement of the central nervous system
  • Recipient of solid organ transplant
  • Cardiovascular disease that is uncontrolled, increases risk for Torsades de Pointes or that was diagnosed within 6 months prior to the first dose of study treatment including, but not limited to: (a) Myocardial infarction; (b) Severe or unstable angina; (c) Clinically significant cardiac arrhythmias, including bradycardia (<50 beats per minute); (d) Uncontrolled (persistent) hypertension: (example, blood pressure greater than [>] 140/90 millimeters of mercury [mm Hg]; (e) Acute neurologic events such as stroke or transient ischemic attack, intracranial or subarachnoid hemorrhage, intracranial trauma; (f) Venous thromboembolic events (example, pulmonary embolism) within 1 month prior to the first dose of study treatment ;(g) Congestive heart failure (NYHA class III to IV); (h) Pericarditis or clinically significant pericardial effusion; (i) Myocarditis; (j) Endocarditis (k) Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected for hypoalbuminemia)
  • Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to grade 1 or less
  • Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation
  • Participants with diagnosis of Fanconi anemia, Kostmann syndrome, Shwachman diamond syndrome, or any other known bone marrow failure syndrome

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：非随机化
  • 介入模型：顺序分配
  • 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：Arm A: Relapsed/Refractory Setting

Participants with relapsed/refractory AML harboring NPM1, KMT2A, NUP98, or NUP214 alterations will receive bleximenib in combination with either venetoclax (VEN) (Cohort A1: bleximenib+VEN) or azacitidine (AZA) (Cohort A2: bleximenib +AZA) or VEN+AZA (Cohort A3: bleximenib+VEN+AZA) or VEN + AZA (Cohort A4: bleximenib + VEN + AZA) in adolescent participants aged greater than or equal to (>=) 12 years and less than (<) 18 years of age, to select the recommended phase 2 dose (RP2D) of bleximenib in combination with VEN, AZA or VEN+AZA (dose selection). In dose expansion portion of the study, participants will receive bleximenib in combination with AML directed therapies at the RP2D(s).
药品：Bleximenib

Participants will receive bleximenib.

其他名称：
  • JNJ-75276617
药品：Venetoclax (VEN)

Participants will receive VEN.

药品：Azacitidine (AZA)

Participants will receive AZA.
实验性的：Arm B: Newly Diagnosed Chemotherapy Ineligible Setting

Participants will receive bleximenib in combination with VEN+AZA as frontline chemo therapy for newly diagnosed AML participants harboring KMT2A, NPM1, NUP98, or NUP214 alterations who are >=75 years of age or >=18 years of age to <75 years of age with comorbidities that preclude the use of intensive induction chemotherapy.
药品：Bleximenib

Participants will receive bleximenib.

其他名称：
  • JNJ-75276617
药品：Venetoclax (VEN)

Participants will receive VEN.

药品：Azacitidine (AZA)

Participants will receive AZA.
实验性的：Arm C: Newly Diagnosed Chemotherapy Eligible Setting

Participants will receive combination of bleximenib with cytarabine+daunorubicin or idarubicin chemotherapy as frontline treatment regimen for participants >= 18 to <75 years of age with AML harboring NPM1, KMT2A, NUP98, or NUP214 alterations and eligible for intensive chemotherapy.
药品：Bleximenib

Participants will receive bleximenib.

其他名称：
  • JNJ-75276617
药品：Cytarabine

Participants will receive cytarabine.

药品：Daunorubicin or Idarubicin

Participants will receive daunorubicin or idarubicin.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants with Adverse Events (AEs)
大体时间：Up to 3 Years 3 months

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 3 Years 3 months
Number of Participants with Adverse Events (AEs) by Severity
大体时间：Up to 3 Years 3 months

Number of Participants with AEs by severity will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Up to 3 Years 3 months
Number of Participants with Dose-limiting Toxicity (DLT)
大体时间：End of Cycle 1 (28 days)

Number of participants with DLT will be reported according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
End of Cycle 1 (28 days)

次要结果测量

结果测量
措施说明
大体时间
Plasma Concentration of Bleximenib
大体时间：Up to 3 Years 3 months

Plasma samples will be analyzed to determine concentrations of bleximenib using a validated, specific, and sensitive method.
Up to 3 Years 3 months
Number of Participants with Depletion of Leukemic Blasts
大体时间：Up to 3 Years 3 months

Number of participants with depletion of leukemic blasts will be reported.
Up to 3 Years 3 months
Percentage of Participants who Achieve Complete Remission (CR)
大体时间：Up to 3 Years 3 months

Percentage of participants who achieve complete Remission (CR) will be reported. CR is defined as Bone marrow blasts less than (<) 5 percent (%); Absence of circulating blasts; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (>=) 1.0*10^9/Liter (L) (1,000/microliter [mcL]); Platelet count >= 100 * 10^9/L (100,000/mcL).
Up to 3 Years 3 months
Percentage of Participants who Achieve Complete Remission with Partial Hematologic Recovery (CRh)
大体时间：Up to 3 Years 3 months

Percentage of participants who achieve complete remission with partial hematologic recovery (CRh) will be reported. CRh is defined as All criteria of CR with both ANC >0.5 * 10^9/L (500/mcL) and platelet count >50 * 10^9/L (50,000/mcL).
Up to 3 Years 3 months
Percentage of Participants who Achieve Complete Remission with Incomplete Hematologic Recovery (CRi)
大体时间：Up to 3 Years 3 months

Percentage of participants who achieve complete remission with incomplete hematologic recovery (CRi) will be reported. CRi is defined as All CR criteria except for residual neutropenia (<1.0*10^9/L [1,000/mcL]) or thrombocytopenia (<100 * 10^9/L [100,000/mcL]).
Up to 3 Years 3 months
Percentage of Participants who Achieved Overall Response
大体时间：Up to 3 Years 3 months

Percentage of participants who achieve overall response will be reported. Overall response rate (ORR) is defined as the percentage of participants achieving CR, CRh, or CRi, morphologic leukemia-free state (MLFS) or partial remission (PR).
Up to 3 Years 3 months

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

Janssen Research & Development, LLC

调查人员

  • 研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2022年10月4日

初级完成 (估计的)

2026年10月30日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2022年7月8日

首先提交符合 QC 标准的

2022年7月8日

首次发布 (实际的)

2022年7月12日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9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

  • CR109124
  • 2021-003999-14 (EudraCT编号)
  • 75276617ALE1002 (其他标识符：Janssen Research & Development, LLC)
  • 2023-506582-58-00 (注册表标识符：EUCT number)
  • 2023 (美国 NIH 拨款/合同)

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 data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

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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