NCT04269811

Flu-Bu-Mel Conditioning Regimen for Myeloid Disease

Phase II Study ofFlu-Bu-Mel Conditioning Regimen for Patients With Myeloid Disease Undergoing Allogeneic Stem Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be 5-day Fludarabine, 2-day Busulifan and 2-day melphalan

Detailed description

For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be Fludarabine (30mg/m2, d-7 to d-3) + Busulifan 3.2mg/kg (d-7 to d-6) + melphalan 70mg/m2 (d-4 and d-3). The GVHD prophylaxis will be PT-CY (Cyclophosphamide 50mg/kg d+3 and d+4) + low-dose ATG (2.5mg/kg) on d+15.

Conditions

• Relapse Rate After Allo-HSCT

Interventions

Type	Name	Description
DRUG	Flu-Bu-Mel	5-day fludarabine + 2-day busulfan (3.2mg/kg) + 2-day melphalan (50-70mg/m2)

Timeline

• Start date: 2020-01-15
• Primary completion: 2023-03-30
• Completion: 2023-06-30
• First posted: 2020-02-17
• Last updated: 2023-10-25

Locations

2 sites across 1 country: China