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)
- How long the study runs
- Study runs about 112 months (dates as stated)
- About the drug or intervention
- Bleximenib — drug: Bleximenib is administered orally.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 2 Years and over
- Who
- All
- Number of participants
- 420
- Started
- 2021-05-19
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for acute leukemia
- • Phase1/Phase2 - 420 participants
- • The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion)
Who can take part?
- • Ages 2 Years and over
- • Diagnosed with acute leukemia
Where?
- • Cardiff - University Hospital of Wales
- • Leeds - Leeds Teaching Hospitals NHS Trust
- • Liverpool - The Clatterbridge Cancer Centre
- • London - Guys and St Thomas NHS Foundation Trust
- • +4 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 determine the recommended Phase 2 dose(s) (RP2D\[s\]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.
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: 2 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Phase 1:
- ✓Age 2 years to less than (\<) 18 years of age (pediatric cohort only), all other cohorts 18 years and above
- ✓Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
- ✓Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin...
- ✓Phase: 2
Who cannot take part
- ✗Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia...
- ✗Active central nervous system (CNS) disease
- ✗Prior solid organ transplantation
- ✗QTc according to Fridericia's formula (QTcF) for males \>= 450 millisecond (msec) or for females \>= 470 msec....
See the full criteria
Where Is This Study? (8 UK sites)
University Hospital of Wales
Cardiff CF14 4XW, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds LS9 7TF, United Kingdom
The Clatterbridge Cancer Centre
Liverpool L7 8YA, United Kingdom
Guys and St Thomas NHS Foundation Trust
London SE1 9RT, United Kingdom
University College London Hospitals
London W1T 7HA, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Christie Nhs Foundation Trust
Manchester M20 4BX, United Kingdom
Oxford University Hospitals NHS Trust
Oxfordshire OX3 7LE, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth PL6 8DH, United Kingdom
How to Get in Touch
Study Contact
Sponsor contactCONTACT
