VA vs DA for Newly Diagnosed Hig-risk AML

Sex: All

Ages: 18 Years – 64 Years

Healthy volunteers: No

Phase: PHASE2, PHASE3

Enrollment: 116

Sponsor: The First Affiliated Hospital of Soochow University

Location: The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology Suzhou Jiangsu

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 Criteria

Inclusion Criteria: 1. Gender: female or male. 2. Age:18-64 years old. 3. Patients with newly diagnosed AML according to the WHO 2022 classification. 4. AML patients with adverse risk features according to the 2022 European Leukemia Net risk stratification. 5. Untreated AML (hydroxyurea, and low dose cytarabine with cummulative dose \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05939180). StuddyBuddy aggregates publicly available trial information.