drugset / Trial / NCT05521087
A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 (\[KMT2A1\], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).
Timeline
- Start
- 2025-12-26
- Primary completion
- 2026-09-11
- Completion
- 2030-01-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bleximenib | Small molecule | — | Oral |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | Pegaspargase | Protein / enzyme biologic | — | Intravenous |
| Background | Vincristine | Small molecule | — | Intravenous |