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

Last Updated June 3, 2025

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CR109124

OVERVIEW

Sexes Eligible for Study
all
Age
12+ years
Phase
phase 1
Sites
32 Sites
Status

Recruiting

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).

CONDITIONS

Leukemia, Myeloid, Acute

ELIGIBILITY

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

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Australia, France, Germany, Italy, Spain, United Kingdom, Canada

Country (8)	City or Province (32)	Status
United States	Birmingham The University of Alabama at Birmingham	RECRUITING
United States	Duarte City of Hope	RECRUITING
United States	Boston Massachusetts General Hospital	RECRUITING
United States	New York Albert Einstein College Of Medicine	RECRUITING
United States	Charlotte Novant Health	RECRUITING
United States	Winston-Salem Novant Health Forsyth Medical Center	RECRUITING
United States	Houston MD Anderson	RECRUITING
Australia	Clayton Monash Medical Centre	RECRUITING
Australia	Melbourne Peter MacCallum Cancer Centre	RECRUITING
Australia	Westmead Westmead Hospital	RECRUITING
France	Marseille Cedex 9 Institut Paoli Calmettes	RECRUITING
France	Toulouse Cedex 9 Institut Universitaire du Cancer Toulouse Oncopole	RECRUITING
France	Tours CHU de Tours - Hôpital de Bretonneau	RECRUITING
Germany	Dresden Universitatsklinikum Carl Gustav Carus Dresden	RECRUITING
Germany	Heidelberg Universitaetsklinikum Heidelberg	RECRUITING
Germany	Leipzig Universitaetsklinikum Leipzig	RECRUITING
Germany	Ulm Universitatsklinikum Ulm	RECRUITING
Italy	Bologna Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna	RECRUITING
Italy	Meldola Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori	RECRUITING
Italy	Milano ASST Grande Ospedale Metropolitano Niguarda	RECRUITING
Italy	Rozzano IRCCS Istituto Clinico Humanitas	RECRUITING
Spain	Barcelona Hosp. de La Santa Creu I Sant Pau	RECRUITING
Spain	Barcelona Hosp Clinic de Barcelona	RECRUITING
Spain	Barcelona Hosp Univ Vall D Hebron	RECRUITING
Spain	Madrid Hosp Univ Fund Jimenez Diaz	RECRUITING
Spain	Pamplona Clinica Univ. de Navarra	RECRUITING
United Kingdom	London University College London Hospitals NHSFT	RECRUITING
United Kingdom	Manchester Christie Hospital NHS Trust	RECRUITING
United Kingdom	Oxfordshire Oxford University Hospitals NHS Trust	RECRUITING
Canada	Toronto Princess Margaret Cancer Centre University Health Network	RECRUITING
France	Rennes Cedex 9 Chu Rennes Hopital Pontchaillou	RECRUITING
Germany	Berlin Charite Universitaetsmedizin Berlin	RECRUITING

Geo Locations

33.52066, -86.80249

34.13945, -117.97729

42.35843, -71.05977

40.71427, -74.00597

35.22709, -80.84313

36.09986, -80.24422

29.76328, -95.36327

-37.91667, 145.11667

-37.814, 144.96332

-33.80383, 150.98768

43.29551, 5.38958

43.60426, 1.44367

47.38333, 0.68333

51.05089, 13.73832

49.40768, 8.69079

51.33962, 12.37129

48.39841, 9.99155

44.49381, 11.33875

44.12775, 12.0626

45.46427, 9.18951

45.38193, 9.1559

41.38879, 2.15899

40.4165, -3.70256

42.81687, -1.64323

51.50853, -0.12574

53.48095, -2.23743

51.750337, -1.2146896

43.70011, -79.4163

48.11198, -1.67429

52.52437, 13.41053

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

33.52066, -86.80249

34.13945, -117.97729

42.35843, -71.05977

40.71427, -74.00597

35.22709, -80.84313

36.09986, -80.24422

29.76328, -95.36327

-37.91667, 145.11667

-37.814, 144.96332

-33.80383, 150.98768

43.29551, 5.38958

43.60426, 1.44367

47.38333, 0.68333

51.05089, 13.73832

49.40768, 8.69079

51.33962, 12.37129

48.39841, 9.99155

44.49381, 11.33875

44.12775, 12.0626

45.46427, 9.18951

45.38193, 9.1559

41.38879, 2.15899

41.38879, 2.15899

41.38879, 2.15899

40.4165, -3.70256

42.81687, -1.64323

51.50853, -0.12574

53.48095, -2.23743

51.750337, -1.2146896

43.70011, -79.4163

48.11198, -1.67429

52.52437, 13.41053

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