NCT00516152

Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT

Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 15 Years – 61 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of \< or equal to 40% at 100 days. A TRM of \> or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of \>40% at 1-year following transplant.

Conditions

• Chronic Myeloid Leukemia
• Acute Myelogenous Leukemia
• Myelodysplasia
• Acute Lymphocytic Leukemia
• Severe Aplastic Anemia
• Non-Hodgkin's Lymphoma
• Lymphoproliferative Disease
• Multiple Myeloma
• Advanced Myeloproliferative Disease

Interventions

Type	Name	Description
DRUG	Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF	Day Preparative Regimen for GVHD Prophylaxis * 7 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 6 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 5 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 4 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV * 3 Fludarabine 30 mg/m(2)IV * 2 REST Tacrolimus 0.01 mg/kg CIVI * 1 REST 0 Unrelated Stem Cell/Bone Marrow Infusion * 1 Methotrexate 5mg/m(2)IV * 3 Methotrexate 5mg/m(2)IV * 6 Methotrexate 5mg/m(2)IV * 7 G-CSF 5mcg/kg SQ daily * 11 Methotrexate 5mg/m(2)IV * 90 Evaluate Response

Timeline

• Start date: 2002-11-01
• Completion: 2007-11-01
• First posted: 2007-08-15
• Last updated: 2009-01-26

Locations

1 site across 1 country: United States