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Looking for participantsPhase3

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

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT06852222

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Bleximenib (drug), Venetoclax (VEN) (drug), Azacitidine (AZA) (drug), Placebo (drug)
How long the study runs
Study runs about 50 months (dates as stated)
About the drug or intervention
Bleximenib — drug: Bleximenib will be administered orally. · Venetoclax (VEN) — drug: VEN will be administered orally. · Azacitidine (AZA) — drug: AZA will be administered intravenously or subcutaneously. · Placebo — drug: Placebo will be administered orally.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
600
Started
2025-06-04
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for leukemia, myeloid, acute
  • • Phase3 - 600 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with leukemia, myeloid, acute

Where?

  • • Brighton - Royal Sussex County Hospital
  • • Cambridge - Addenbrookes Hospital
  • • Canterbury - Kent and Canterbury Hospital
  • • Colchester - Colchester Hospital University NHS
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Leukemia, Myeloid, Acute

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 2 or better

Biomarkers mentioned

gene rearrangedgene mutated

Treatment history

Treatments you must have had:

  • ✓ adequate hepatic and renal function
  • ✓ for, the study and is willing to participate in the study

What the study is looking for

  • ✓Be 18 years of age or older at the time of agreement to take part
  • ✓Participants must have adequate liver and kidney function
  • ✓A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90...
  • ✓Must sign an agreement to take part form indicating that the participant understands the purpose of, and procedures...

Who cannot take part

  • ✗Diagnosis of acute promyelocytic leukemia (APL)
  • ✗Known active leukemic involvement of the central nervous system (CNS)
  • ✗Recipient of solid organ transplant
  • ✗Active infectious hepatitis
  • ✗Live, attenuated vaccine within 4 weeks of randomization
See the full 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

Where Is This Study? (9 UK sites)

Royal Sussex County Hospital

Brighton BN2 5BE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Scott Harfield

uhsussex.research@nhs.net01273 696955 ext. 67497

Addenbrookes Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Kent and Canterbury Hospital

Canterbury CT1 3NG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Caroline Cowley, Research & Innovation/Clinical Trials Unit Manager

ekhuft.researchandinnovation@nhs.net01227 783169

Colchester Hospital University NHS

Colchester CO4 5JL, United Kingdom

Recruiting

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Donna Noonan

gwh.researchmanagement@nhs.net01793 605565

The Clatterbridge Cancer Centre

Liverpool L7 8YA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

Guys' and St Thomas' NHS Trust

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Derriford Hospital

Plymouth PL6 8DH, United Kingdom

Recruiting

Worthing Hospital

Worthing BN11 2DH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Scott Harfield

uhsussex.research@nhs.net01273 696955 ext. 67497

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09