A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.

Trial Details

NCT ID

NCT04811560

Phase

PHASE1 / PHASE2

Sponsor

Janssen Research & Development, LLC

Status

RECRUITING

Cancer Type

Leukemia

Interventions

Bleximenib

Locations (sample)

Duarte, California, United States|34.13945,-117.97729
Orange, California, United States|33.78779,-117.85311
San Francisco, California, United States|37.77493,-122.41942
San Francisco, California, United States|37.77493,-122.41942
Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility Criteria

Age 2 years to less than (\<) 18 years of age (pediatric cohort only), all other cohorts 18 years and above
Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene …
Participants greater than 18 years are eligible

For full eligibility, visit ClinicalTrials.gov.

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