N=~400
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Key eligibility criteria*:
- ECOG PS 0–2
- WBC count: ≤20 × 109/L
- Adequate renal and hepatic function
- No active CNS involvement
Phase 1:
- R/R acute leukemia with KMT2A, NPM1, NUP98, or NUP214 gene alterations
- Age ≥2
Phase 2:
- R/R AML with KMT2Ar or NPM1m
- Adults ≥18
Primary outcomes:
Phase 1:
- Safety, including AEs and DLTs
Phase 2:
- Rate of CR/CRh
Secondary outcomes†:
Phase 1:
- ORR, DOR, TTR, PK
Phase 2:
- ORR, duration of CR/CRh, TTR, EFS, OS, safety, PK
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of secondary outcomes.
AE, adverse event; AML, acute myeloid leukemia; CNS, central nervous system; CR, complete remission; CRh, complete remission with partial hematologic recovery; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EFS, event-free survival; KMT2A, histone-lysine N-methyltransferase 2A; KMT2Ar, KMT2A rearrangement; NPM1, nucleophosmin 1; NPM1m, NPM1 mutated; NUP98, nucleoporin 98; NUP214, nucleoporin 214; ORR, overall response rate; OS, overall survival; PK, pharmacokinetics; PO, orally; RP2D, recommended Phase 2 dose; R/R, relapsed or refractory; TTR, time to response; WBC, white blood cell.