RecruitingNot ApplicableNCT06386302

Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

A Multicenter, Randomized, Controlled Clinical Trial of Chidamide Combined With Venetoclax and Azacitidine in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) Who Are Not Suitable for Intensive Chemotherapy


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

184 participants

Start Date

Aug 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a 3-drug combination — chidamide, venetoclax, and azacitidine — for people newly diagnosed with acute myeloid leukemia (AML), a fast-growing blood cancer, who are not healthy enough for intensive chemotherapy. **You may be eligible if...** - You are 18 or older with a new diagnosis of AML (not a certain subtype called M3) - You have not received any prior treatment for AML - You are not a candidate for intensive chemotherapy due to age (75+) or health conditions like heart disease, reduced lung function, or kidney issues - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have another active cancer - You have previously taken chidamide, venetoclax, or azacitidine - Your AML is classified as low-risk - You have AML that has spread to the brain - You are pregnant or breastfeeding - You have had a serious heart event (like a heart attack) in the past year 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

30 mg/d orally twice-weekly

DRUGVenetoclax

100 mg d1 200 mg d 2 400 mg d3-d28 Orally

DRUGazacitidine

75 mg/m 2 /d subcutaneous injection or IV d1-d7


Locations(1)

Blood Hospital

Tianjin, Tianjin Municipality, China

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NCT06386302


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