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 3, 2025

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75276617AML3001

OVERVIEW

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

3
Sites
41 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:

Canada, Czechia, Germany, Israel, Italy, Poland, Slovakia, Spain, Taiwan

Country (9)	City or Province (41)	Status
Canada	London Western University & London Health Sciences Centre	RECRUITING
Czechia	Ceske Budejovice Nemocnice Ceske Budejovice a s	RECRUITING
Czechia	Hradec Kralove Hepato-gastroenterologie HK, s.r.o.	RECRUITING
Czechia	Praha 9 ISCARE a.s.	RECRUITING
Germany	Augsburg Klinikum Augsburg	RECRUITING
Germany	Berlin Charite Universitaetsmedizin Berlin	RECRUITING
Germany	Berlin Praxis Für Gastroenteroligie	RECRUITING
Germany	Dachau Medizinisches Versorgungszentrum (MVZ) Dachau	RECRUITING
Germany	Frankfurt Universitatsklinikum Frankfurt/ Medizinische Klinik 1	RECRUITING
Germany	Gottingen Universitatsmedizin Gottingen	RECRUITING
Germany	Hannover Medizinische Hochschule Hannover	RECRUITING
Germany	Kiel Universitatsklinikum Schleswig Holstein	RECRUITING
Germany	Lüneburg Staedtisches Klinikum Lueneburg	RECRUITING
Germany	Ulm Universitaetsklinikum Ulm	RECRUITING
Israel	Haifa Rambam Medical Center	RECRUITING
Israel	Holon The Edith Wolfson Medical Center	RECRUITING
Israel	Jerusalem Hadassah Medical Organization	RECRUITING
Israel	Nahariya Galilee Medical Center	RECRUITING
Israel	Petah Tikva Rabin Medical Center	RECRUITING
Israel	Ramat Gan The Chaim Sheba Medical Center	RECRUITING
Israel	Tel Aviv Tel Aviv Sourasky Medical Center	RECRUITING
Italy	Milano IRCCS Ospedale San Raffaele	RECRUITING
Italy	Roma Fondazione Policlinico Universitario A Gemelli IRCCS	RECRUITING
Poland	Bydgoszcz NZOZ Centrum Medyczne KERmed	RECRUITING
Poland	Rzeszow Centrum Medyczne Medyk	RECRUITING
Poland	Torun GASTROMED Sp. z o.o.	RECRUITING
Poland	Warszawa WIP Warsaw IBD Point Profesor Kierkus	RECRUITING
Poland	Wroclaw Centrum Medyczne Oporow	RECRUITING
Poland	Wroclaw EuroMediCare Szpital Specjalistyczny z Przychodnia	RECRUITING
Poland	Zamosc ETG Zamosc	RECRUITING
Slovakia	Banska Bystrica FNsP F.D.R. Banska Bystrica	RECRUITING
Spain	Alicante Hosp. Gral. Univ. Dr. Balmis	RECRUITING
Spain	Ferrol Hosp. Univ. de La Paz	RECRUITING
Spain	Madrid Hosp. Univ. de La Princesa	RECRUITING
Spain	Madrid Hosp. Univ. Pta. de Hierro Majadahonda	RECRUITING
Spain	Valencia Hosp. Clinico Univ. de Valencia	RECRUITING
Spain	Vigo Hosp. Alvaro Cunqueiro	RECRUITING
Taiwan	Changhua Chang-Hua Christian Hospital	RECRUITING
Taiwan	New Taipei Far Eastern Memorial Hospital	RECRUITING
Taiwan	Taipei National Taiwan University Hospital	RECRUITING
Taiwan	Taipei Taipei Veterans General Hospital	RECRUITING

Geo Locations

42.98339, -81.23304

48.97447, 14.47434

50.20923, 15.83277

50.08804, 14.42076

48.37154, 10.89851

52.52437, 13.41053

48.26, 11.43402

50.11552, 8.68417

51.53443, 9.93228

52.37052, 9.73322

54.32133, 10.13489

53.2509, 10.41409

48.39841, 9.99155

32.81841, 34.9885

32.01034, 34.77918

31.76904, 35.21633

33.00892, 35.09814

32.08707, 34.88747

32.08227, 34.81065

32.08088, 34.78057

45.46427, 9.18951

41.89193, 12.51133

53.1235, 18.00762

50.04132, 21.99901

53.01375, 18.59814

52.22977, 21.01178

51.1, 17.03333

50.72314, 23.25196

48.73946, 19.15349

38.34517, -0.48149

43.4896, -8.21942

40.4165, -3.70256

39.46975, -0.37739

42.23282, -8.72264

24.07327, 120.56276

25.01111, 121.44583

25.04776, 121.53185

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

42.98339, -81.23304

48.97447, 14.47434

50.20923, 15.83277

50.08804, 14.42076

48.37154, 10.89851

52.52437, 13.41053

52.52437, 13.41053

48.26, 11.43402

50.11552, 8.68417

51.53443, 9.93228

52.37052, 9.73322

54.32133, 10.13489

53.2509, 10.41409

48.39841, 9.99155

32.81841, 34.9885

32.01034, 34.77918

31.76904, 35.21633

33.00892, 35.09814

32.08707, 34.88747

32.08227, 34.81065

32.08088, 34.78057

45.46427, 9.18951

41.89193, 12.51133

53.1235, 18.00762

50.04132, 21.99901

53.01375, 18.59814

52.22977, 21.01178

51.1, 17.03333

51.1, 17.03333

50.72314, 23.25196

48.73946, 19.15349

38.34517, -0.48149

43.4896, -8.21942

40.4165, -3.70256

40.4165, -3.70256

39.46975, -0.37739

42.23282, -8.72264

24.07327, 120.56276

25.01111, 121.44583

25.04776, 121.53185

25.04776, 121.53185

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