VAH Versus VA for Salvage Therapy of R/R-AML

Summary

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.

Conditions

• Venetoclax Combined With Azacitidine Plus Homoharringtonine
• Venetoclax Combined With Azacitidine

Interventions

DRUG

VEN combined with azacitidine plus homoharringtonine

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.

DRUG

VEN combined with azacitidine

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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Zhongshan People's Hospital, Guangdong, China

  collaborator OTHER

• Shenzhen Hospital of Southern Medical University

  collaborator OTHER

• Peking University Shenzhen Hospital

  collaborator OTHER

• Shenzhen Second People's Hospital

  collaborator OTHER

• The Seventh Affiliated Hospital of Sun Yat-sen University

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• First People's Hospital of Chenzhou

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Qifa Liu · Department of Hematology,Nanfang Hospital, Southern Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2022-12-31

Completion

2023-12-31

Countries

• China

Study Locations