REVEAL-ND NPM1
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed AML with an NPM1 mutation (REVEAL-ND NPM1)
IRAS ID
1012542
Contact name
NAP NAP
Contact email
Sponsor organisation
Syndax Pharmaceuticals Inc.
ISRCTN Number
ISRCTN42617850
Research summary
This study aims to determine if adding a drug called revumenib to standard chemotherapy can improve outcomes for patients with newly diagnosed acute myeloid leukemia (AML) that has a specific genetic mutation called NPM1. AML is an aggressive blood cancer, and while current treatments can lead to remission, many patients still relapse. This research is important because it could potentially lead to a more effective first-line treatment for this type of AML.
The study will test revumenib, an oral medication that targets a specific protein interaction involved in AML development. The use of revumenib in this study is investigational, which means that revumenib is not approved by any regulatory authorities for this indication. Participants aged 12 and older with newly diagnosed NPM1-mutated AML who are eligible for intensive chemotherapy can participate.
Participants will be randomly assigned to receive either revumenib or a placebo along with standard chemotherapy. This is a Phase 3, randomised, double-blind, placebo-controlled study which means neither participants nor doctors will know who receives revumenib versus placebo.
Patients will undergo regular blood tests, bone marrow biopsies, imaging scans and other assessments to monitor their response to treatment and any side effects.
There is no guarantee that taking part in this study will improve participants’ health and it is possible that their condition may get worse. However, participants will contribute to important research that could improve treatment options for AML.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/LO/0831
Date of REC Opinion
11 Dec 2025
REC opinion
Further Information Favourable Opinion