drugset / Trial / NCT02283177
A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This pilot study is designed to evaluate the safety and tolerability of oral crenolanib besylate given sequentially during standard induction and consolidation chemotherapy in patients with newly diagnosed AML with FLT3 activating mutations.
Timeline
- Start
- 2015-01
- Primary completion
- 2019-12
- Completion
- 2019-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crenolanib | Small molecule | 100 mg | Oral |
| Subject | Daunorubicin | Small molecule | 60 mg/m2 | — |
| Subject | Daunorubicin | Small molecule | 90 mg/m2 | — |
| Subject | Idarubicin | Small molecule | 12 mg | — |
| Background | Cytarabine | Small molecule | 1 g | — |
| Background | Cytarabine | Small molecule | 3 g | — |