NCT06770257

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

A Randomized Phase ll Study Evaluating the Efficacy and Safety of Combination Therapy of Daunorubicin, Cytarabine Liposomes and Venetoclax Versus Combination Therapy of Azacitidine and Venetoclax in Newly Diagnosed AML Patients Not Eligible for Intensive Chemotherapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	daunorubicin, cytarabine liposomes	First induction: 100 units/m\^2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m\^2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m\^2 by 90-minute IV infusion on Days 1 and 3.
DRUG	Azacitidine	Given SC on days 1-7
DRUG	Venetoclax	Given PO on days 1-14 or 1-21 or 1-28

Timeline

• Start date: 2025-12-10
• Primary completion: 2026-12-10
• Completion: 2027-06-10
• First posted: 2025-01-13
• Last updated: 2025-06-03