HOVON 181 AML/AML SG 37-25*
Myeloid malignancies
A Phase 3, randomized, double-blind study of bleximenib or placebo in combination with standard induction and consolidation therapy followed by maintenance for the treatment of patients with newly diagnosed KMT2A-rearranged or NPM1-mutant AML eligible for intensive chemotherapy
Phase
Compound
Bleximenib (menin inhibitor) + cytarabine + daunorubicin or idarubicin
NCT identifier
NCT07223814
Enrollment
N=~875
For more information, including
contact details, please visit
ClinicalTrials.gov
contact details, please visit
ClinicalTrials.gov
Study overview & design
Key eligibility criteria†:
- ND AML with KMT2Ar or NPM1m
- Eligible for intensive chemotherapy
- Adults ≥18
- ECOG PS 0–2
- Adequate renal and hepatic functions
- No active leukemic involvement of the CNS
- No solid organ transplant
- No significant cardiac disorder ≤6 months of randomization
Study
design
Primary outcome:
- EFS
Secondary outcomes:
- OS
- Rates of CR, CRh, CRi
- Prolongation of CR
- Percentage of participants undergoing allo-SCT
*Study sponsored by HOVON/AMLSG. †Not a complete list of inclusion and exclusion criteria.
‘7+3’, cytarabine + daunorubicin or idarubicin chemotherapy; allo-SCT, allogeneic stem cell transplant; AML, acute myeloid leukemia; CNS, central nervous system; CR, complete remission; CRh, complete remission with partial hematologic recovery; CRi, complete remission with incomplete hematologic recovery; ECOG PS, Eastern Cooperative Oncology Group performance status; EFS, event-free survival; KMT2A, histone-lysine N-methyltransferase 2A; KMT2Ar, KMT2A rearranged; ND, newly diagnosed; NPM1, nucleophosmin 1; NPM1m, NPM1 mutated; OS, overall survival.