drugset / Trial / NCT06770257
Daunorubicin, Cytarabine Liposomes Plus Venetoclax vs Azacitidine Plus Venetoclax in AML Patients Unfit for Intensive Chemotherapy
Phase 2
Withdrawn
Institute of Hematology & Blood Diseases Hospital, China
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Daunorubicin, Cytarabine Liposomes(CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.) is a dual-drug liposomal encapsulation of cytarabine and daunorubicin at a fixed 5:1 synergistic molar ratio. This is a phase 2, randomized, controlled study in patients who are \>= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for intensive induction therapy. In this study, patients will be randomized by 1:1:1 to receive Daunorubicin, Cytarabine Liposomes + Venetoclax(14d) or Daunorubicin, Cytarabine Liposomes + Venetoclax(21d) or Venetoclax + Azacitidine. Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit.
Timeline
- Start
- 2025-12-10
- Primary completion
- 2026-12-10
- Completion
- 2027-06-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azacitidine | Other / unclassified | — | Subcutaneous |
| Subject | Cytarabine | Small molecule | — | Intravenous |
| Subject | Daunorubicin | Small molecule | — | Intravenous |
| Subject | Venetoclax | Small molecule | — | — |