RecruitingPhase 1Phase 2NCT05522192

Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia

Clinical Study of Venetoclax Combined With Mitoxantrone Liposome in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Sponsor

Hui Zeng

Enrollment

70 participants

Start Date

Jul 21, 2022

Study Type

INTERVENTIONAL

Conditions

Relapsed or Refractory Acute Myeloid Leukemia

Summary

This study is an open-label, single-arm, phase I/II clinical study. Phase I is a multi-center, dose-escalation study, aiming to explore the maximum tolerated dose (MTD) of venetoclax combined with mitoxantrone liposome in the treatment of relapsed or refractory acute myeloid leukemia (AML), and determine the recommended dose for phase II (RP2D); Phase II is a multi-center, exploratory study, aiming to explore efficacy of venetoclax combined with mitoxantrone liposome in the treatment of relapsed and refractory AML patients, and to explore the differences in the efficacy of this combination therapy with different gene mutations.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called mitoxantrone hydrochloride liposome injection in patients with relapsed or refractory acute myeloid leukemia (AML) — a type of blood cancer that has come back or stopped responding to standard chemotherapy. **You may be eligible if...** - You have been diagnosed with AML confirmed by bone marrow testing - Your AML has relapsed or not responded to at least 2 rounds of standard chemotherapy - Your overall health is reasonably good (ECOG 0–2) - Your heart function (ejection fraction) is at least 45% - Your liver and kidney function are within acceptable limits - Your oxygen levels are adequate - Your expected survival is more than 3 months **You may NOT be eligible if...** - Your AML has not met the diagnostic criteria for relapsed or refractory disease - Your heart function is significantly impaired - Your organ function is too poor for treatment - You are pregnant or breastfeeding 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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