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
- Revumenib (drug), Chemotherapy Regimen (drug), HiDAC (drug)
- How long the study runs
- Study runs about 33 months (dates as stated)
- About the drug or intervention
- Revumenib — drug: Participants will receive revumenib orally during Induction, Consolidation, and Maintenance until meeting criteria for discontinuation. · Chemotherapy Regimen — drug: Induction: Participants will receive an intravenous (IV), 2-drug combination of cytarabine and either daunorubicin or idarubicin. · HiDAC — drug: Consolidation: Participants will receive HiDAC IV.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 96
- Started
- 2024-05-21
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for acute myeloid leukemias
- • Phase1 - 96 participants
- • The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of revumenib in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with acute myeloid leukemias
Where?
- • London - Hammersmith Hospital
- • Sutton - The Royal Marsden NHS
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of revumenib in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.
More detail
The Dose Escalation portion of this study will identify the maximum tolerated dose, or if different, the recommended Phase 2 dose of revumenib to be used in combination with intensive chemotherapy and in maintenance monotherapy following intensive chemotherapy in participants with newly diagnosed AML harboring alterations in KMT2A, NPM1, or NUP98 genes. In the Dose Expansion portion of the study, safety and preliminary efficacy of revumenib may be explored in expansion cohorts at tolerated dose levels. In both Dose Escalation and Dose Expansion, the treatment period will consist of an induction phase (up to 2 cycles), a consolidation phase (up to 4 cycles and could include hematopoietic stem cell transplant for participants who are transplant eligible and have an available donor), and a maintenance monotherapy phase with revumenib. The cycle duration will be 28 days.
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 - 75 Years
- Who can join: All genders
What the study is looking for
- ✓Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria.
- ✓Newly diagnosed and previously untreated AML and eligible to receive intensive drug treatment.
- ✓KMT2Ar, NPM1m, or NUP98r mutations identified by local laboratory prior to the first dose of revumenib.
- ✓activity scale performance status ≤2 and ≤1 if \>65 years old.
- ✓Adequate liver, kidney, and heart function.
Who cannot take part
- ✗Diagnosis of acute promyelocytic leukemia.
- ✗Clinically active central nervous system leukemia (blasts detected in cerebrospinal fluid, radiographic or clinical...
- ✗Fridericia's corrected QT interval (QTcF) \>450 milliseconds (average of triplicate), diagnosis or suspicion of Long...
- ✗Any gastrointestinal issue of the upper gastrointestinal tract that might affect oral drug absorption or ingestion.
- ✗Cirrhosis with a Child-Pugh score of B or C.
See the full criteria
Where Is This Study? (2 UK sites)
Hammersmith Hospital
London W12 0HS, United Kingdom
The Royal Marsden NHS
Sutton SM2 5PT, United Kingdom
