A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
NCT ID: NCT05453903
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
200 participants
INTERVENTIONAL
2022-10-04
2027-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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).
Bleximenib
Participants will receive bleximenib.
Venetoclax (VEN)
Participants will receive VEN.
Azacitidine (AZA)
Participants will receive AZA.
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.
Bleximenib
Participants will receive bleximenib.
Venetoclax (VEN)
Participants will receive VEN.
Azacitidine (AZA)
Participants will receive AZA.
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.
Bleximenib
Participants will receive bleximenib.
Cytarabine
Participants will receive cytarabine.
Daunorubicin or Idarubicin
Participants will receive daunorubicin or idarubicin.
Interventions
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Bleximenib
Participants will receive bleximenib.
Venetoclax (VEN)
Participants will receive VEN.
Azacitidine (AZA)
Participants will receive AZA.
Cytarabine
Participants will receive cytarabine.
Daunorubicin or Idarubicin
Participants will receive daunorubicin or idarubicin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Albert Einstein College Of Medicine
New York, New York, United States
Novant Health
Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
MD Anderson
Houston, Texas, United States
Monash Medical Centre
Clayton, , Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
Westmead Hospital
Westmead, , Australia
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada
Institut Paoli Calmettes
Marseille, , France
Chu Rennes Hopital Pontchaillou
Rennes, , France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, , France
CHU de Tours - Hôpital de Bretonneau
Tours, , France
Charite Universitaetsmedizin Berlin
Berlin, , Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
Bologna, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
IRCCS Istituto Clinico Humanitas
Rozzano, , Italy
Hosp. de La Santa Creu I Sant Pau
Barcelona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp Univ Fund Jimenez Diaz
Madrid, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
University College London Hospitals NHSFT
London, , United Kingdom
Christie Hospital NHS Trust
Manchester, , United Kingdom
Oxford University Hospitals NHS Trust
Oxfordshire, , United Kingdom
Countries
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Central Contacts
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References
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Kwon MC, Thuring JW, Querolle O, Dai X, Verhulst T, Pande V, Marien A, Goffin D, Wenge DV, Yue H, Cutler JA, Jin C, Perner F, Hogeling SM, Shaffer PL, Jacobs F, Vinken P, Cai W, Keersmaekers V, Eyassu F, Bhogal B, Verstraeten K, El Ashkar S, Perry JA, Jayaguru P, Barreyro L, Kuchnio A, Darville N, Krosky D, Urbanietz G, Verbist B, Edwards JP, Cowley GS, Kirkpatrick R, Steele R, Ferrante L, Guttke C, Daskalakis N, Pietsch EC, Wilson DM, Attar R, Elsayed Y, Fischer ES, Schuringa JJ, Armstrong SA, Packman K, Philippar U. Preclinical efficacy of the potent, selective menin-KMT2A inhibitor JNJ-75276617 (bleximenib) in KMT2A- and NPM1-altered leukemias. Blood. 2024 Sep 12;144(11):1206-1220. doi: 10.1182/blood.2023022480.
Other Identifiers
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75276617ALE1002
Identifier Type: OTHER
Identifier Source: secondary_id
2021-003999-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506582-58-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109124
Identifier Type: -
Identifier Source: org_study_id