NCT07244367

Maintenance Venetoclax in AML Fit Patients

Maintenance Venetoclax Based Therapy Post Complete Remission in AML Fit Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

this study will explore the efficacy of maintenance SC cytarabine + venetoclax therapy as regard disease free survival (DFS) in AML fit patients who achieved CR after highly aggressive chemotherapy as bridge for BMT or if BMT will be delayed or canceled due to any other reason.

Detailed description

this study is a prospective,phase III , randomized ,open , interventional study include young fit patients who will receive maintenance venetoclax +subcutaneous cytarabine as bridge for BMT or if BMT will be delayed

Conditions

• Acute Myeloid Leukaemia (AML)

Interventions

Type	Name	Description
DRUG	SC cytarabine +Venetoclax	SC Cytarabine (20 mg) administrated on days 1-7 ,,Venetoclax (100 mg ) administrated on days 1-7,,Voriconazole 200 mg 1x2 administrated on days , Best supportive care as needed . Up to 12 cycles or until patients undergo bone marrow transplantation

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

2 sites across 1 country: Egypt