This is a prospective, multi-center, phase 3 randomized controlled clinical study comparing
VAH and VA regimens for the salvage treatment of the patients with relapsed/refractory AML.
Approximately 164 subjects will be randomized in a 1:1 ratio to receive VAH regimen (82
subjects) or VA regimen (82 subjects) for salvage therapy. Randomization is done with
permuted blocks (block size four), and implemented through an interactive web-based response
system.
VAH regimen: VEN begins at 100 mg on day 1 and increases stepwise over 3 days to reach the
target dose of 400 mg (100 mg, 200 mg, 400 mg); dosing is continued at 400 mg per day from
day 4 through day 14; azacitidine (75 mg/m²) is administered subcutaneously on days 1-7, and
HHT (1 mg/m²) on days 1-7.
VA regimen: The use of VEN is just the same as it dose in VAH regimen except lasting for 28
days. The use of azacitidine is exactly the same as VAH group does.
The primary endpoint was overall response rate (ORR) after 2 cycles of trial therapy.
The secondary endpoints were CRc after 2 cycles of trial therapy, overall survival (OS),
event-free survival (EFS) and relapse at 2 year, and safety.
Phase:
Phase 3
Details
Lead Sponsor:
Nanfang Hospital of Southern Medical University
Collaborators:
First Affiliated Hospital of Guangxi Medical University First People's Hospital of Chenzhou Peking University Shenzhen Hospital Shenzhen Hospital of Southern Medical University Shenzhen Second People's Hospital Southern Medical University, China Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University The Affiliated Hospital of Qingdao University The Seventh Affiliated Hospital of Sun Yat-sen University Zhongshan People's Hospital, Guangdong, China