A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
ConditionAcute Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2+
SponsorJanssen Research & Development, LLC
About this trial
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.
Eligibility criteria
Qualifiers
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 (NUP98 or NUP214) alterations
Participants greater than 18 years are eligible
Disqualifiers
Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria
Active central nervous system (CNS) disease
Prior solid organ transplantation
QTc according to Fridericia's formula (QTcF) for males >= 450 millisecond (msec) or for females >= 470 msec. Participants with a family history of Long QT syndrome are excluded
Trial design
Treatments tested in this trial
- Bleximenib
Treatment groups
420 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov