Mitoxantrone Hydrochloride Liposome Combined With Chemotherapy in Untreated de Novo Acute Myeloid Leukemia

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT05941585
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Mitoxantrone hydrochloride liposome injection30mg/m2 — DRUG
    Mitoxantrone hydrochloride liposome intravenous infusion on day 1 (30mg/m2)
  • HomoharringtonineD1-D7(2mg/m2/day) — DRUG
    Homoharringtonine intravenous infusion on D1-D7,2mg/m2/day in a 4-week treatment cycle.
  • Venetoclax (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day) — DRUG
    Venetoclax d4-d12 (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day)in a 4-week treatment cycle.
  • Cytarabine(standard-dose:d1-d7100mg/m2/day) — DRUG
    Cytarabine intravenous infusion on d1-d7 ,100mg/m2/day
  • Cytarabine(intermediate-dose:d1-d4100mg/m2/day, d5-d7 1g/m2) — DRUG
    d1-d4100mg/m2/day, d5-d7 1g/m2
  • Mitoxantrone hydrochloride liposome injection24mg/m2 — DRUG
    Mitoxantrone hydrochloride liposome intravenous infusion on day 1 (24mg/m2)

Study Details

The purpose of this study is to determine the safety, efficacy and pharmacokinetics of mitoxantrone hydrochloride liposome injection combined with chemotherapy in previously untreated de novo acute myeloid leukemia.

Key Dates

Start date
Aug 8, 2023
Status verified
Feb 2025
Primary completion
Jan 17, 2025
Completion
Jan 17, 2025

Study Design

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

Arms

  • Experimental: mitoxantrone hydrochloride liposome injection combined with of cytarabine
    Patients will receive mitoxantrone hydrochloride liposome injection combined with standard-dose of cytarabine.
  • Experimental: mitoxantrone hydrochloride liposome with cytarabine and homoharringtonine
    Patients will receive mitoxantrone hydrochloride liposome injection combined with intermediate-dose of cytarabine and homoharringtonine.
  • Experimental: mitoxantrone hydrochloride liposome injection combined with cytarabine and venetoclax
    Patients will receive mitoxantrone hydrochloride liposome injection with cytarabine and venetoclax.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately one month ]

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