RecruitingPhase 2NCT06621212

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

A Prospective, Multi-center, Phase 2 Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Standard-dose Cytarabine and Venetoclax in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

72 participants

Start Date

Jul 5, 2024

Study Type

INTERVENTIONAL

Conditions

Myeloid Malignancy Relapsed/Refractory Acute Myeloid Leukaemia

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a chemotherapy combination — mitoxantrone hydrochloride liposome with standard-dose cytarabine — in adults with relapsed or treatment-resistant acute myeloid leukemia (AML), a type of blood cancer. These are patients whose AML came back or did not respond to prior treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with relapsed or refractory AML (not acute promyelocytic leukemia) - Your AML did not respond to at least 1 round of initial treatment, or it came back after remission - You have acceptable physical health and organ function - Your life expectancy is more than 3 months **You may NOT be eligible if...** - You have acute promyelocytic leukemia (APL) - You have severe liver, kidney, or heart problems - You are pregnant or breastfeeding - You have uncontrolled infections 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.

Interested in this trial?

Get notified about updates and connect with the research team.