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A Study of Bleximenib, Venetoclax, and Azacitidine for Newly Diagnosed AML

This study is for people newly diagnosed with acute myeloid leukemia (AML) who have specific gene changes (KMT2Ar or NPM1m) and cannot receive intensive chemotherapy. It is testing a new drug, bleximenib, along with two existing drugs, Venetoclax and Azacitidine. Researchers want to see if this combination works better than Venetoclax and Azacitidine alone, or with a placebo (an inactive substance). The main goals are to see how many participants achieve complete remission (when signs of cancer disappear) and how long participants live. This study plans to enroll 600 participants.

Study design
This study plans to enroll 600 participants. It compares different drug combinations, including bleximenib, Venetoclax, Azacitidine, and a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 4 years and 1 month to assess outcomes like complete remission and overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06852222

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~600 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:BleximenibVenetoclax (VEN)Azacitidine (AZA)Placebo

At a glance

Recruiting sites
262 of 262 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants who Achieve Complete Remission (CR)
Measured over Up to 4 years and 1 month
+1 more outcome measured

Conditions

Leukemia, Myeloid, Acute

Explore related trials

Acute Myeloid LeukemiaKMT2A GeneNPM1 Gene

Where it's being run

262 sites across 55 states
China25
Japan16
Spain16
Italy14
France13
Germany11
Brazil9
United Kingdom9

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percentage of Participants who Achieve Complete Remission (CR)Up to 4 years and 1 month

    CR is defined as Bone marrow blasts less than (\<) 5 percent (%); Absence of circulating blasts; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (\>=) 1.0 \* 10\^9/Liter (1,000/microliter \[mcL\]); Platelet count \>= 100 \* 10\^9/L (100,000/mcL).

  • Overall Survival (OS)Up to 4 years and 1 month

    Overall survival time is defined as the time duration from the date of randomization to death due to any cause.