RecruitingPhase 2Phase 3NCT05939180

VA vs DA for Newly Diagnosed Hig-risk AML

Study of the Efficacy and Safety of Venetoclax Plus Azacytidine Versus Daunorubicin Plus Cytarabine in Adult Acute Myeloid Leukemia (AML) Patients With Adverse Risk Features

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

116 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

Summary

This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy combination regimens — venetoclax plus azacitidine (VA) versus decitabine plus azacitidine (DA) — for newly diagnosed high-risk acute myeloid leukemia (AML), a fast-growing blood cancer. **You may be eligible if...** - You are between 18 and 64 years old - You have been newly diagnosed with AML according to current WHO standards - Your AML is classified as high-risk (adverse risk) by European LeukemiaNet 2022 criteria - You have not received any prior AML treatment (except for short-term hydroxyurea) **You may NOT be eligible if...** - You have previously been treated for AML or a related blood disorder - You have AML that developed from a prior blood cancer (secondary AML) treated with certain chemotherapy agents - You have active serious infections or organ dysfunction - You have a prior diagnosis of certain other cancers 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 Oral Tablet

VA regimen: azacytidine, 75mg/m2, subcutaneously, on days 1-7; venetoclax, orally, once a day, 100mg, d1; 200mg, d2; 400mg, days 3-28.

DRUGDaunorubicin

DA regimen: daunorubicin (60mg/m2) on days 1-3, intraveneously injection, and cytarabine (100mg/m2) on days 1-7, intraveneously injection, for 1 cycle.

Locations(2)

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, China

Ethical Committee of the First Affliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT05939180

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