NCT00815568

Feasibility and Efficacy Study of Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation (HCT) With Fludarabine, Busulfan, and Total Body Irradiation (TBI)

Prospective Phase II Clinical Trial of Myeloablative Conditioning Regimen With Fludarabine and Busulfan Plus 400 cGy Total Body Irradiation for Hematologic Malignancies

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the OS, RFS, and TRM after HCT with low-dose total body irradiation, fludarabine, and busulfan conditioning.

Detailed description

Conventional allogeneic hematopoietic cell transplantation (HCT) for patients with hematological malignancies involves conditioning with high doses of systemic chemo/radiation therapy such as cyclophosphamide (CY) plus 1200 or 1000 cGy total body irradiation (TBI; CY/TBI) or busulfan (Bu) / CY (BuCy). Unfortunately, such regimens have been associated with significant toxicities, limiting their use to otherwise healthy, relatively young patients. Recently, Fludarabine plus 4 day dose of busulfan (FluBu4) containing myeloablative regimen has been introduced successfully without increasing transplant-related mortality (TRM). To improve transplant outcomes without increasing the risk of recurrence, Russell et al introduced 400cGy of TBI with antithymocyte (ATG, 4.5mg/Kg) into FluBu4 regimen with successful outcomes.

Conditions

• AML
• MDS
• ALL
• CML
• Lymphoma

Interventions

Type	Name	Description
DRUG	fludarabine phosphate, busulfan	Fludarabine ( 30mg/m2, iv, D-7\~D-2) Busulfan (3.2mg/kg, iv, D-6\~D-3) Total body irradiation (200cGy/day, D-2,-1)

Timeline

• Start date: 2008-08-01
• Primary completion: 2011-12-01
• Completion: 2012-12-01
• First posted: 2008-12-30
• Last updated: 2008-12-30

Locations

1 site across 1 country: South Korea