Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT06621199
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Mitoxantrone hydrochloride liposome — DRUG
    Mitoxantrone hydrochloride liposome 24 mg/m\^2 on day 1, every 4 weeks
  • Cytarabine — DRUG
    Cytarabine 100 mg/m\^2 on day 1-5, every 4 weeks
  • Venetoclax — DRUG
    Venetoclax 100 mg on day 2，200 mg on day 3，400 mg on day 4-10, every 4 weeks

Study Details

This is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. The primary endpoint is 2-year event free survival(EFS).

Key Dates

Start date
Jul 8, 2024
Status verified
Jul 2024
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Modified MAV regimen
    Mitoxantrone hydrochloride liposome ×1 day, cytarabine × 5 days combined with venetoclax as induction regimen

Primary Outcome Measure

2-year event-free survival (EFS) rate [ Time Frame: up to 2 years ]

Central Contacts

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