Recruiting NCT06852222

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Phase III Interventional Leukemia, Myeloid, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Bleximenib, Venetoclax (VEN), Azacitidine (AZA), Placebo.
Who it may be relevant to: Registry conditions: Leukemia, Myeloid, Acute. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Austria, Belgium, Brazil +20
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy

Overview

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 newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.

Interventions

Drug Bleximenib
Bleximenib will be administered orally.
Drug Venetoclax (VEN)
VEN will be administered orally.
Drug Azacitidine (AZA)
AZA will be administered intravenously or subcutaneously.
Drug Placebo
Placebo will be administered orally.

Primary outcome measures

Percentage of Participants who Achieve Complete Remission (CR) [Time frame: Up to 4 years and 1 month]
Overall Survival (OS) [Time frame: Up to 4 years and 1 month]

Secondary outcome measures (9)

Event-free survival (EFS) [Time frame: Up to 4 years and 1 month]
Duration of CR [Time frame: Up to 4 years and 1 month]
Time to CR [Time frame: Up to 4 years and 1 month]
Rate of CR Without Measurable Residual Disease (MRD-) [Time frame: Up to 4 years and 1 month]
Percentage of Participants who Achieved Transfusion Independence [Time frame: Up to 4 years and 1 month]
Percentage of Participants with Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT) [Time frame: Up to 4 years and 1 month]
Number of Participants with Adverse Events (AEs) [Time frame: Up to 4 years and 1 month]
Number of Participants with Abnormalities in Clinical Laboratory Parameters [Time frame: Up to 4 years and 1 month]
Serum Concentration of Bleximenib [Time frame: Up to 4 years and 1 month]

Eligibility criteria

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) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care
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 for at least 90 days 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, azacitidine, or venetoclax excipients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Triple blind
Primary purpose: Treatment