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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (9 UK sites)
Royal Sussex County Hospital
Brighton BN2 5BE, United Kingdom
Addenbrookes Hospital
Cambridge CB2 0QQ, United Kingdom
Kent and Canterbury Hospital
Canterbury CT1 3NG, United Kingdom
Caroline Cowley, Research & Innovation/Clinical Trials Unit Manager
ekhuft.researchandinnovation@nhs.net01227 783169Colchester Hospital University NHS
Colchester CO4 5JL, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
The Clatterbridge Cancer Centre
Liverpool L7 8YA, United Kingdom
Guys' and St Thomas' NHS Trust
London SE1 9RT, United Kingdom
Derriford Hospital
Plymouth PL6 8DH, United Kingdom
Worthing Hospital
Worthing BN11 2DH, United Kingdom
How to Get in Touch
Study Contact
Sponsor contactCONTACT
