Daunorubicin, Cytarabine Liposomes Plus Venetoclax vs Azacitidine Plus Venetoclax in AML Patients Unfit for Intensive Chemotherapy

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

Outcome

Outcome not reported

Stopped: “The project was terminated as the genetic office did not approve it.”

Drugs

Indications