A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

Last updated: May 22, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Leukemia

Treatment

Bleximenib

Cytarabine

Venetoclax (VEN)

Clinical Study ID

NCT05453903
CR109124
75276617ALE1002
2023-506582-58-00
2021-003999-14
  • Ages > 12
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 (ArmA, cohort A4)

  • Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novoor secondary AML; b) relapsed/refractory (Arm A only); c) harboring KMT2A, NPM1,NUP98, or NUP214 alterations; d) Participants may receive emergency leukapheresisand/or cytarabine as cytoreductive therapy according to local practice guidelines

  • Pretreatment clinical laboratory values meeting the following criteria -listedbelow: 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 (forparticipants <16 years of age) or >70 Karnofsky scale (for participants >16 years ofage)

  • A female of childbearing potential must have a negative highly sensitive serumbeta-human chorionic gonadotropin at screening and within 48 hours prior to thefirst dose of study treatment

  • Must sign an informed consent form (ICF) indicating participant (or their legallyauthorized representative) understands the purpose of the study and proceduresrequired for the study and is willing to participate in the study

  • Willing and able to adhere to the prohibitions and restrictions specified in thisprotocol

Exclusion

Exclusion Criteria:

  • Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia orjuvenile 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 Pointesor that was diagnosed within 6 months prior to the first dose of study treatmentincluding, but not limited to: (a) Myocardial infarction; (b) Severe or unstableangina; (c) Clinically significant cardiac arrhythmias, including bradycardia (<50beats per minute); (d) Uncontrolled (persistent) hypertension: (example, bloodpressure greater than [>] 140/90 millimeters of mercury [mm Hg]; (e) Acuteneurologic events such as stroke or transient ischemic attack, intracranial orsubarachnoid hemorrhage, intracranial trauma; (f) Venous thromboembolic events (example, pulmonary embolism) within 1 month prior to the first dose of studytreatment ;(g) Congestive heart failure (NYHA class III to IV); (h) Pericarditis orclinically significant pericardial effusion; (i) Myocarditis; (j) Endocarditis (k)Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected forhypoalbuminemia)

  • Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia,neutropenia, anemia) from previous anticancer therapy that has not resolved tobaseline or to grade 1 or less

  • Pulmonary compromise that requires the need for supplemental oxygen use to maintainadequate oxygenation

  • Participants with diagnosis of Fanconi anemia, Kostmann syndrome, Shwachman diamondsyndrome, or any other known bone marrow failure syndrome

Study Design

Total Participants: 200
Treatment Group(s): 6
Primary Treatment: Bleximenib
Phase: 1
Study Start date:
October 04, 2022
Estimated Completion Date:
March 19, 2027

Connect with a study center

  • Monash Medical Centre

    Clayton, 3168
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, 2145
    Australia

    Active - Recruiting

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario M5G 1Z5
    Canada

    Active - Recruiting

  • Institut Paoli Calmettes

    Marseille Cedex 9, 13273
    France

    Active - Recruiting

  • Chu Rennes - Hopital Pontchaillou

    Rennes Cedex 9, 35033
    France

    Site Not Available

  • Chu Rennes Hopital Pontchaillou

    Rennes Cedex 9, 35033
    France

    Active - Recruiting

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse Cedex 9, 31100
    France

    Active - Recruiting

  • CHU de Tours - Hôpital de Bretonneau

    Tours, 37044
    France

    Active - Recruiting

  • Charite Universitaetsmedizin Berlin

    Berlin, 13353
    Germany

    Active - Recruiting

  • Charite Universitatsmedizin Berlin

    Berlin, 13353
    Germany

    Active - Recruiting

  • Charité Universitätsmedizin Berlin

    Berlin, 13353
    Germany

    Active - Recruiting

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Universitatsklinikum Leipzig

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Universitatsklinikum Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

  • Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Active - Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Hosp Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 8035
    Spain

    Active - Recruiting

  • Hosp. Clinic I Provincial de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp. Univ. Vall D Hebron

    Barcelona, 8035
    Spain

    Active - Recruiting

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Hosp. de la Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hosp. Univ. Fund. Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • University College London Hospitals NHSFT

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • Christie Hospital NHS Trust

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS Trust

    Oxfordshire, OX3 7LE
    United Kingdom

    Active - Recruiting

  • The University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Albert Einstein College Of Medicine

    New York, New York 10461
    United States

    Active - Recruiting

  • Novant Health

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • MD Anderson

    Houston, Texas 77030
    United States

    Active - Recruiting

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