NCT07023588

Study on Optimizing the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease

A Multicenter, Open-label, Prospective, Randomized Controlled Study to Optimize the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Yehui Tan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, open-label, prospective, randomized controlled study to optimize the treatment of patients with acute myeloid leukemia based on early peripheral blood minimal residual disease

Detailed description

This study is a randomized controlled, prospective clinical trial, with the leading unit being the First Hospital of Jilin University. It aims to screen patients with a suboptimal response to chemotherapy based on early peripheral blood minimal residual disease (MRD) levels, and explore the efficacy and safety of adding venetoclax. A total of 70 subjects are expected to be enrolled, with 35 subjects each in the experimental group and the control group. The study will collect data on subjects' demographics, other baseline characteristics, medication usage, prognosis, etc. Statistical analysis will be performed on the collected data to compare efficacy indicators.

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	Venetoclax	Patients identified with a suboptimal response to chemotherapy based on minimal residual disease (MRD) levels in peripheral blood on Day 6 will initiate venetoclax therapy added on Day 8, administered for 7 days.

Timeline

• Start date: 2025-06-01
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2025-06-17
• Last updated: 2025-08-08

Locations

1 site across 1 country: China