RecruitingPhase 2NCT05566054

Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia

A Multicenter, Randomized, Controlled Clinical Trial of Venetoclax, Azacytidine Combined With Chidamide for the Treatment of Newly Diagnosed Acute Monocytic Leukemia Patients That Are Ineligible for Intensive Chemotherapy


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

92 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is to investigate the therapeutic efficacy and side effect of venetoclax, azacytidine combined with chidamide for newly diagnosed acute monocytic leukemia patients that are ineligible for intensive chemotherapy


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a triple combination of drugs — venetoclax, azacitidine, and chidamide — for newly diagnosed acute monocytic leukemia (a specific subtype of blood cancer called AML-M5) in patients who are not fit enough for intensive chemotherapy. The three drugs work together to stop cancer cell growth and promote cell death. **You may be eligible if...** - You have been newly diagnosed with acute monocytic leukemia (AML-M5) - You are 60 years of age or older, OR between 18–59 with serious health problems that make intensive chemotherapy too risky (such as heart disease, poor lung function, or kidney issues) - You have not received prior treatment for this leukemia - You are expected to survive at least 12 weeks - You meet laboratory requirements (blood counts, liver function, etc.) **You may NOT be eligible if...** - You have already received chemotherapy, radiation, or a stem cell transplant in the past 4 weeks - You are pregnant or breastfeeding - You have health conditions that make you ineligible based on your doctor's assessment 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

DRUGChidamide

Chidamide 10mg orally daily for 7 days (d1-d7)

DRUGAzacitidine

azacytidine 75mg/m2 daily for 7 days (d1-d7)

DRUGVenetoclax

Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28)


Locations(1)

The First Affliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT05566054


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