drugset / Trial / NCT04716114
A Study of SKLB1028 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory (R/R) AML With FLT3-Mutated
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized，multicenter, open-label Phase III, clinical study to confirm the efficacy and safety of SKLB1028 in patients with relapsed or refractory(R/R) FLT3-Mutated Acute Myeloid Leukemia（AML）compared to salvage chemotherapy.
Timeline
- Start
- 2021-03-24
- Primary completion
- 2025-12
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aclarubicin | Small molecule | 20 mg | Intravenous |
| Comparator | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 10 mg | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 20 mg | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 100 mg/m2 | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 200 mg/m2 | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 1000 mg/m2 | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 2000 mg/m2 | Subcutaneous |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Comparator | Homoharringtonine | Small molecule | 2 mg/m2 | Intravenous |
| Subject | RUSERONTINIB | Small molecule | 150 mg | Oral |
| Comparator | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 300000 mg/m2 | Subcutaneous |