drugset / Trial / NCT06788756
L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML
RandomizedFactorialTriple-blindTreatment
Summary
This pivotal phase 2/3, multi-center, adaptive design study of L-Annamycin for Injection in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML is divided into two parts, Part A and Part B.
Timeline
- Start
- 2025-03-12
- Primary completion
- 2029-08
- Completion
- 2030-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | L-Annamycin | Unknown | 190 mg/m2 | Intravenous |
| Comparator | L-Annamycin | Unknown | 230 mg/m2 | Intravenous |
| Comparator | Cytarabine | Small molecule | 2 g | Intravenous |