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 (NCT06652438)

This trial aims to investigate the use of Revumenib, a new drug being investigated for the treatment of specific types of Acute Myeloid Leukaemia (AML) in patients who are ineligible for intensive chemotherapy. It will look at whether the addition of Revumenib to the normal treatment for AML can improve the results of treatment. All participants on this trial will be treated with Azacitidine + Venetoclax which is the standard therapy for your specific type of AML. However, half of patients will randomly be assigned to receive an additional drug, Revumenib while the other half will only receive the standard treatment.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Sun Loo

Key inclusion data

INCLUSION: Patient with newly diagnosed NPM1-mutated AML, consistent with NPM1c, according to the 2022 International Consensus Classification (i.e. greater or equal to 10% blasts) OR Patient with newly diagnosed KMT2A-rearranged AML according to the 2022 International Consensus Classification (i.e. greater or equal to 10% blasts). KMT2A partial tandem duplications or deletions are NOT eligible. Patient is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria: Patient must have a projected life expectancy of at least 12 weeks (as assessed by the treating physician). Female patient must be of nonchildbearing potential or, if of childbearing potential (not surgically sterile and not postmenopausal) agree to avoid pregnancy during the study and for 6 months after the final study drug administration. Male patients must use a latex condom during any sexual contact with women of childbearing potential (WOCBP), even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 6 months after the final study drug administration). In addition, their female partners of childbearing potential must use a highly effective method of birth control. EXCLUSION: Patient has previously been treated for AML; a treatment period with hydroxyurea to control WBC counts is allowed; prior treatment with a hypomethylating agent for MDS-EB is not allowed; prior treatment with erythropoiesis-stimulating agents or luspatercept for MDS is allowed. Significant active cardiac disease within 3 months prior to the start of study treatment. History of stroke or intracranial hemorrhage within 6 months prior to randomization. Immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding and/or disseminated intravascular coagulation. Patient with a currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at < 30% risk of relapse within one year.