drugset / Trial / NCT03324243
A Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia
NaSingle-groupOpen-labelTreatment
Summary
This is a phase II, multicenter, single-arm study to assess the safety and feasibility of combining crenolanib with fludarabine and cytarabine chemotherapy in pediatric patients with relapsed/refractory FLT3-mutated AML. Patients will receive up to two courses of salvage chemotherapy with fludarabine, cytarabine, and crenolanib. Response will be assessed between day 29-43 of each course.
Timeline
- Start
- 2018-01
- Primary completion
- 2020-12
- Completion
- 2020-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crenolanib | Small molecule | 66.7 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Subject | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |