drugset / Trial / NCT06376162
Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with chemotherapy (FLA) in children with relapsed or refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemia based on safety and pharmacokinetics (PK).
Timeline
- Start
- 2025-03-18
- Primary completion
- 2027-01
- Completion
- 2027-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ziftomenib | Small molecule | — | Oral |
| Background | Cytarabine | Small molecule | 67 mg/kg | Intravenous |
| Background | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 1 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |