J&J Congress Resource Hub | HOVON 181 AML/AML SG 37-25

HOVON 181 AML/AML SG 37-25* Myeloid malignancies

A Phase 3, 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

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^†:

Secondary outcomes:

OS
Rates of CR, CRh, CRi
Duration of CR
% allo-SCT
AEs

*Study sponsored by HOVON/AMLSG. ^†Not a complete list of inclusion and exclusion criteria. ^‡Second induction cycle: IDAC ± anthracycline. ^§All participants eligible for maintenance, regardless of allo-HSCT status.

‘7+3’, cytarabine + daunorubicin or idarubicin chemotherapy; AE, adverse event; allo-HSCT, allogeneic hematopoietic 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; IDAC, intermediate dose cytarabine; KMT2Ar, histone-lysine N-methyltransferase 2A rearrangement; MRD, minimal residual disease; ND, newly diagnosed; NPM1m, nucleophosmin 1 mutation; OS, overall survival.

Key eligibility criteria†:

Primary outcome†:

Secondary outcomes:

Key eligibility criteria^†:

Primary outcome^†: