Testing Bleximenib with Venetoclax against a placebo for leukemia, myeloid, acute
Official title: A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
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
Interventions
Bleximenib
Bleximenib will be administered orally.
Venetoclax (VEN)
VEN will be administered orally.
Azacitidine (AZA)
AZA will be administered intravenously or subcutaneously.
Placebo
Placebo will be administered orally.
Canadian Sites (8)
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Cancercare Manitoba
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Health Sciences Centre Victoria Hospital
London, Ontario, Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Be 18 years of age or older at the time of informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +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
- +Participants must have adequate hepatic and renal function
- +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
- +A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocolProtocolThe detailed plan a study must follow.Read more →-specified contraception while enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → 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
- +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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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 careStandard of careThe treatment normally given for a condition outside a study.Read more →
Exclusion
- −Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients
- −Active infectious hepatitis
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −Live, attenuated vaccine within 4 weeks of randomization
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Bleximenib, Venetoclax (VEN), Azacitidine (AZA), PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 600 people.
The study is currently expected to finish around August 2029.
The main measurement is taken over: Up to 4 years and 1 month.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percentage of Participants who Achieve Complete Remission (CR) — measured over Up to 4 years and 1 month.
Overall Survival (OS) — measured over Up to 4 years and 1 month.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06852222 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About BleximenibDrug
Bleximenib will be administered orally.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Venetoclax (VEN)Drug
VEN will be administered orally.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Azacitidine (AZA)Drug
AZA will be administered intravenously or subcutaneously.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Placebo will be administered orally.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 4 years and 1 month.
The study as a whole is currently expected to finish around 2029-08-15.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 600 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 15 locations, including: Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada, and 9 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (8)
Henry Ford Health System
Detroit, Michigan, United States
Trinity Health Michigan Heart - Ann Arbor Campus
Ypsilanti, Michigan, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
New York Presbyterian - Weill Cornell
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Einstein-Montefiore Medical Center
The Bronx, New York, United States
Swedish Cancer Institute
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.