RecruitingPhase 2NCT06394011

Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients

A Single-center, Single-arm, Prospective Clinical Study on the Efficacy and Safety of Venetoclax and Azacitidine Combined With HAAG in the Induction Treatment of Intermediate and High-risk Acute Myeloid Leukemia


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

60 participants

Start Date

Feb 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new combination chemotherapy regimen (VA + HAAG) for adults newly diagnosed with intermediate or high-risk acute myeloid leukemia (AML) — a fast-growing blood cancer. **You may be eligible if...** - You are 18–65 years old - You were recently diagnosed with intermediate or high-risk AML (not a type called APL/M3) - You have never had chemotherapy or targeted therapy before - Your liver, kidney, and pancreas are functioning well enough (based on blood tests) - You are generally functional day-to-day (able to care for yourself) **You may NOT be eligible if...** - Your AML developed from a previous blood disorder called chronic myelogenous leukemia - You have another active cancer requiring treatment - You have a serious uncontrolled infection - You have significant heart problems (weak heart function) - You have HIV or active hepatitis B or C 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

DRUGvenetoclax, azacitidine and HAAG regimen

Venetoclax:100mg, qd, d1;200mg, qd, d2;400 mg, qd, d3\~10, per os; Azacitidine:75mg/m2/d, d1\~7, subcutaneous injection; Homoharringtonine:1mg/d, d4\~10, intravenous infusion; Aclarubicin:10mg/d, d4\~7, intravenous infusion; Cytarabine:10mg/m2,q12h,d4\~10, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection;


Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

View Full Details on ClinicalTrials.gov

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NCT06394011


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