Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07521124
NA

ABC Maintenance Therapy for AML

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2026-06-01

Completion Date

2029-06-01

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

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.

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog

Wuhan, China