drugset / Trial / NCT05876832
A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FLT3-ITD-Mutation (ALIVE)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the clinical benefit of XY0206 therapy in participants with FLT3-ITD mutated AML who are refractory to or have relapsed after prior AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study is also to investigate the efficacy of XY0206 as assessed by CR/CRh rate in these subjects。
Timeline
- Start
- 2023-06-15
- Primary completion
- 2027-07-01
- Completion
- 2027-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 20 mg | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 100 mg/m2 | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 1 g | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 2 g | Subcutaneous |
| Comparator | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Comparator | Mitoxantrone | Small molecule | 8 mg/m2 | Intravenous |
| Subject | XY0206 | Unknown | 37.5 mg | Oral |