Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT07486479
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Mitoxantrone Hydrochloride Liposome — DRUG
    Mitoxantrone Hydrochloride Liposome: 24 mg/m², administered by intravenous drip (ivgtt) on day 1
  • Venetoclax — DRUG
    Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-9, administered orally (po)
  • Azacitidine — DRUG
    Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7
  • Idarubicin — DRUG
    Idarubicin: 12 mg/m², administered by intravenous drip (ivgtt) on days 1-3
  • Cytarabine — DRUG
    Cytarabine: 100 mg/m², administered by intravenous drip (ivgtt) on days 1-7

Study Details

This study aims to evaluate the efficacy and safety of venetoclax combined with azacitidine and mitoxantrone hydrochloride liposome (MVA) versus idarubicin combined with cytarabine (IA) in the treatment of newly diagnosed AML.

Key Dates

Start date
Mar 10, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MVA
    Patients achieving complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), or morphologic leukemia free state (MLFS) after Cycle 1 proceed to consolidation therapy. Patients achieving a partial response (PR) or demonstrating 50% blast reduction after Cycle 1 receive one additional cycle of re-induction with the same MVA regimen. Those who subsequently achieve CR, CRh, CRi, or MLFS after Cycle 2 proceed to consolidation. Patients with no response (NR) after Cycle 1, or those with NR or PR after Cycle 2, will discontinue study treatment.
  • Active Comparator: IA
    Patients achieving CR, CRh, CRi, or MLFS after Cycle 1 proceed to consolidation therapy. Patients achieving a PR or demonstrating 50% blast reduction after Cycle 1 receive one additional cycle of re-induction with the same IA regimen. Those who subsequently achieve CR, CRh, CRi, or MLFS after Cycle 2 proceed to consolidation. Patients with NR after Cycle 1, or those with NR or PR after Cycle 2, will discontinue study treatment.

Primary Outcome Measure

Composite Complete Remission(CRc) rate after one cycle of induction therapy [ Time Frame: At the end of the first treatment cycle (Day 28 ± 7), each cycle is 28 days). ]

Central Contacts

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