RecruitingPhase 2NCT06434662

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

A Phase II Study of the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection, Cytarabine and Venetoclax in Patients With Relapsed/Refractory AML


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

34 participants

Start Date

Feb 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — a liposomal form of mitoxantrone, cytarabine, and venetoclax — in people with relapsed or refractory acute myeloid leukemia (AML), a blood cancer that has come back or stopped responding to previous treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with AML (excluding acute promyelocytic leukemia) that has relapsed or is refractory, meaning: standard initial treatment failed after 2 cycles, your leukemia returned after a remission, or your minimal residual disease (MRD) went from undetectable to detectable again - Your general health score (ECOG) is 0–2 - Your organ function is adequate for treatment **You may NOT be eligible if...** - You have acute promyelocytic leukemia (a specific AML subtype treated differently) - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You have active serious infections or other major health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmitoxantrone hydrochloride liposome

Mitoxantrone hydrochloride liposome (24 mg/m\^2) on day 1, every 4 weeks

DRUGCytarabine

Cytarabine (1.0 g/m\^2, q12h ) on day 1,3,5, every 4 weeks

DRUGVenetoclax

Venetoclax 100 mg on day 2,200 mg on day 3,400 mg on day 4-10, every 4 weeks


Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06434662


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