EVOLVE 2
Research type
Research Study
Full title
Randomized study to assess revumenib in combination with azacitidine + venetoclax in adult patients with newly diagnosed NPM1-mutated or KMT2A-rearranged AML ineligible for intensive chemotherapy
IRAS ID
1011582
Contact name
M.C. Breems
Contact email
Sponsor organisation
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
Clinicaltrials.gov Identifier
Research summary
Acute Myeloid Leukaemia (AML) is the most aggressive adult blood cancer. Most patients are not cured. For newly diagnosed AML patients the median survival is just 14.5 months with the current treatment called venetoclax and azacitidine (VEN-AZA).
The HOVON 177 AML study will assess if a new tablet called revumenib, improves clinical outcome when combined with VEN-AZA. Revumenib targets only against leukaemia cells with faults in the DNA (the genetic code) of two genes called NPM1 or KMT2A. This study is designed for newly diagnosed AML patients where faults were detected in these genes.
This study will compare adding either revumenib tablets (given to half the patients) or placebo (inactive tablet given to the other half of patients) to VEN-AZA. The study is sponsored by a non-commercial, patient focussed organisation called HOVON, designed by world leading AML doctors and funded by Syndax, a company that makes revumenib.
Participants will receive treatment until it is ineffective or causes too may side effects or whenever the participant wishes to come off study. Treatment duration depends on the patient’s wishes. Patients can continue to receive treatment as long as it benefits them. Average treatment time for patients receiving VEN-AZA and placebo is around 14.5 months. Addition of revumenib will hopefully extend survival to 2 years or longer.
Once treatment ends, participants will be followed up every 3 to 6 months for a maximum of 6 years.
Up to 415 participants will take part.
Study procedures are similar to those carried out routinely (checkups, blood and urine tests, ECGs, radiology and bone marrow tests) to enable treatment to be given safely and monitor treatment effectiveness. Patients will undergo eye assessments and be asked to fill out questionnaires to understand how the disease and its treatment affects quality of life.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0064
Date of REC Opinion
11 Apr 2025
REC opinion
Further Information Favourable Opinion