Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT06434662
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myeloid Malignancy
  • Relapsed/Refractory Acute Myeloid Leukaemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
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 (1.0 g/m\^2, q12h ) on day 1,3,5, 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

The goal of this study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. It will also tentatively explore the correlation between different biological characteristics and therapeutic efficacy. The main questions it aims to answer are:Dose the combination regimen of MAV enhanced the composite complete remission in R/R AML? Participants will receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.

Key Dates

Start date
Feb 29, 2024
Status verified
Mar 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2026

Study Design

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

Arms

  • Experimental: MAV regimen
    mitoxantrone hydrochloride liposome injection, cytarabine combined with venetoclax

Primary Outcome Measure

Composite complete remission (CRc) rate [ Time Frame: At the end of each cycle (each cycle is 28 days), up to 2 cycles ]

Central Contacts

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