NCT00594308

In-Vivo Activated T-Cell Depletion to Prevent GVHD

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease. This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative ("mini" transplant).

Conditions

• Acute Myelogenous Leukemia
• Acute Lymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Chronic Lymphocytic Leukemia
• Myelodysplasia
• Lymphoma, Non-Hodgkin's
• Mantle-Cell Lymphoma
• Hodgkin's Disease
• Multiple Myeloma
• Myelofibrosis

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	60mg/kg/day for two consecutive days (-7,-6).
DRUG	Fludarabine	25mg/m2/day for 5 consecutive days
DRUG	Cyclosporine	3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1.
DRUG	Mycophenolate mofetil	1000 mg will be administered through day +60 and then discontinued if there is no GVHD.
DRUG	Basiliximab	20mg , will be given by intravenous infusion (without an in-line filter) over at least 15 minutes beginning 3 days after engraftment.

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-10-01
• First posted: 2008-01-15
• Last updated: 2014-10-06
• Results posted: 2012-03-20

Locations

1 site across 1 country: United States