NCT07521124

ABC Maintenance Therapy for AML

Efficacy and Safety of Maintenance Treatment With Chidamide, Venetoclax, and Azacitidine for Treatment-Naive Acute Myeloid Leukemia Patients Achieving Complete Remission: A Multicenter Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Study Objectives: To evaluate the Relapse-Free Survival (RFS) and 1-year RFS rate in patients with Acute Myeloid Leukemia (AML) receiving maintenance therapy with Chidamide combined with Venetoclax and Azacitidine. Study Design: Prospective, Multicenter, Interventional Cohort Study. Total Enrollment: 104 subjects. Cohort 1 (MRD-Negative Patients): 61 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. Cohort 2 (MRD-Persistent Positive Patients): 43 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.

Conditions

• Acute Myeloid Leukemia (AML) in Remission

Interventions

Type	Name	Description
DRUG	Cohort 1 (MRD-Negative Patients): 61 subjects	Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.
DRUG	Cohort 2 (MRD-Persistent Positive Patients): 43 subjects	Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: China