Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT06621212
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 (30 mg/m\^2) on day 1, every 4 weeks
  • Cytarabine — DRUG
    Cytarabine (100 mg/m\^2 ) on day 1-7, every 4 weeks
  • Venetoclax — DRUG
    Venetoclax 100 mg on day 2，200 mg on day 3，400 mg on day 4-8, every 4 weeks

Study Details

The purpose of this prospective, multi-center, single-arm, phase 2 study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, standard-dose of cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. The study plan to enroll 72 R/R AML patients who are expected to receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.

Key Dates

Start date
Jul 5, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: MAV regimen
    First induction: Mitoxantrone hydrochloride liposome injection, cytarabine combined with venetoclax. Second induction: Patients who achieved PR or MLFS after the first induction cycle will receive re-induction therapy with the same initial regimen. Consolidation: For patients with CR/CRi, allo-HSCT is recommended. For those currently ineligible for allo-HSCT, age- and fitness-adapted consolidation is advised. For intensive chemotherapy: Cytarabine (\<60y: 2g/m² q12h d1-3; ≥60y: 1g/m² q12h d1-3) + Venetoclax 300mg d1-7, for 2-3 cycles. For non-intensive candidates, an appropriate regimen should be selected per investigator.

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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