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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06770257
Phase
PHASE2
Status
Withdrawn

Conditions

  • Leukemia, Myeloid, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • daunorubicin, cytarabine liposomes — DRUG
    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.
  • Azacitidine — DRUG
    Given SC on days 1-7
  • Venetoclax — DRUG
    Given PO on days 1-14 or 1-21 or 1-28

Study Details

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.

Key Dates

Start date
Dec 10, 2025
Status verified
Dec 2024
Primary completion
Dec 10, 2026
Completion
Jun 10, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ArmA（daunorubicin, cytarabine liposomes plus 14d-venetolcax）
    Patients receive daunorubicin, cytarabine liposomes through intravenous injection(IV) on days 1、3、5, and venetoclax orally（PO） daily on days 1-14. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
  • Experimental: ArmB（daunorubicin, cytarabine liposomes plus 28d-venetolcax）
    Patients receive daunorubicin, cytarabine liposomes IV on days 1、3、5, and venetoclax PO daily on days 1-28. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: ArmC（azacitidine plus 28d-venetoclax）
    Patients receive azacitidine subcutaneously (SC) on days 1-7, and venetoclax PO daily on days 1-28. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Complete remission rate(CR) [ Time Frame: Up to 8 months ]

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