cAMeLot-2
Myeloid malignancies
A Phase 3, double-blind, randomized, placebo-controlled study of
bleximenib (menin inhibitor), venetoclax, and azacitidine for treatment of participants with
newly diagnosed AML
Phase
Compound
Bleximenib (menin inhibitor) + venetoclax + azacitidine
NCT identifier
NCT06852222
Enrollment
N=~600
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- ND AML with KMT2Ar or NPM1m
- Ineligible for intensive chemotherapy
- Adults ≥18
- No active CNS involvement
- No uncontrolled CVD diagnosed within 6 months prior to first dose of treatment
Study
design
Primary outcomes:
- CR
- OS
Secondary outcomes:
- EFS
- MRD-negative CR rate
- Duration of CR
- Time to CR
- % transfusion independence
- % allo-HSCT
- AEs
- Clinical laboratory abnormalities
- PK
*Not a complete list of inclusion and exclusion criteria.
AE, adverse event; allo-HSCT, allogeneic hematopoietic stem cell transplant; AML, acute myeloid leukemia; CNS, central nervous system; CR, complete response; CVD, cardiovascular disease; DOR, duration of response; EFS, event-free survival; IV, intravenous; KMT2Ar, histone-lysine N-methyltransferase 2A rearrangement; MRD, minimal residual disease; ND, newly diagnosed; NPM1m, nucleophosmin 1 mutation; OS, overall survival; PK, pharmacokinetics; PO, orally; R, randomized; SC, subcutaneous.