A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Acute Myeloid L

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Acute Myeloid Leukemia (AML) (cAMeLot-2)

Last Updated May 10, 2025

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75276617AML3001

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 3

3
Sites
19 Sites
Status

Not yet recruiting

SUMMARY

The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with Acute Myeloid Leukemia (AML).

CONDITIONS

Leukemia, Myeloid, Acute

ELIGIBILITY

Inclusion criteria:

* Be 18 years of age or older at the time of informed consent
* Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria
* Ineligible for intensive chemotherapy based on the following criteria: a) >= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) >=18 to <75 years of age with >= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented and approved by the sponsor before enrollment defined in the protocol
* Participants must have adequate hepatic and renal function
* A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
* A male participant must agree to use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
* Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion criteria:

* Diagnosis of acute promyelocytic leukemia (APL)
* Known active leukemic involvement of the central nervous system (CNS)
* Recipient of solid organ transplant
* Any cardiac disorders such as heart attack, uncontrolled/unstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization
* Active infectious hepatitis
* Live, attenuated vaccine within 4 weeks of randomization
* Known allergies, hypersensitivity, or intolerance of bleximenib excipients

Inclusion criteria:

More...

DETAILS

LOCATIONS

Locations in:

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

Country (6)	City or Province (19)	Status
United States	Duarte City of Hope	RECRUITING
United States	Tampa Moffit Cancer center	RECRUITING
United States	Ann Arbor University of Michigan	RECRUITING
United States	New York Memorial Sloan Kettering Cancer Center	RECRUITING
United States	Charlotte Levine Cancer Institute	RECRUITING
United States	Philadelphia University of Pennsylvania	RECRUITING
United States	Nashville Sarah Cannon Cancer Institute	RECRUITING
United States	Houston MD Anderson Cancer Center	RECRUITING
Canada	Toronto Princess Margaret Cancer Centre University Health Network	RECRUITING
France	Paris Hopital Saint Louis	RECRUITING
France	Pierre Benite Cedex CH LYON SUD - Hematology	RECRUITING
Germany	Aachen Universitaetsklinikum der RWTH Aachen	RECRUITING
Germany	Berlin Charite Campus Benjamin Franklin	RECRUITING
Germany	Hannover Medizinische Hochschule Hannover	RECRUITING
Germany	Regensburg Universitaetsklinikum Regensburg	RECRUITING
Spain	Badalona Hosp. Univ. Germans Trias I Pujol	RECRUITING
Spain	Valencia Hosp. Clinico Univ. de Valencia	RECRUITING
United Kingdom	London University College London Hospitals Nhs Foundation Trust	RECRUITING
United Kingdom	Oxford Churchill Hospital	RECRUITING

Geo Locations

34.13945, -117.97729

27.94752, -82.45843

42.27756, -83.74088

40.71427, -74.00597

35.22709, -80.84313

39.95233, -75.16379

36.16589, -86.78444

29.76328, -95.36327

43.70011, -79.4163

48.85341, 2.3488

45.7009, 4.82511

50.77664, 6.08342

52.52437, 13.41053

52.37052, 9.73322

49.01513, 12.10161

41.45004, 2.24741

39.46975, -0.37739

51.50853, -0.12574

51.75222, -1.25596

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.

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