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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
• Age 18-65.
• ECOG score: 0-2.
• No history of previous chemotherapy or target therapy.
• Serum total bilirubin \<= 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) \<= 1.5 times ULN, aspartate aminotransferase (AST) \<=1.5 times ULN;
• Creatinine clearance rate \>=30 mL/min;
• Serum lipase \<= 1.5 times ULN, amylase \<= 1.5 times ULN;
• Capable to understand and willing to participate in this study, signed the informed consent form.
Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Xiaowen Tang, Ph.D
xwtang1020@163.com
(0086)51267780086
Backup
Depei Wu, Ph.D
drwudepei@163.com
(0086)51267780086
Time Frame
Start Date: 2024-02-15
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 60
Treatments
Experimental: VA combined with HAAG
This cohort will determine the safety and efficacy of venetoclax, azacitidine combined with HAAG regimen in newly diagnosed intermediate and high-risk AML patients.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Soochow University