In-Vivo Activated T-Cell Depletion to Prevent GVHD

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Treatments: Basiliximab; Cyclophosphamide; Cyclosporine; Cyclosporins; Fludarabine; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Acute myelogenous leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Chronic lymphocytic leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Mantle cell, Hodgkin's Disease, Multiple Myeloma, Myelofibrosis with disease-specific eligibility requirements as outlined in the protocol

• Donor Requirement: Must have a fully HLA-matched (10 of 10) related or unrelated donor, eighteen years of age or older, who is capable of undergoing GCSF mobilization and apheresis.

Exclusion Criteria:

• Active CNS disease (the presence of leukemic blasts in the CSF)

• Pregnancy or breast-feeding

• SGOT >3x upper limit of normal

• Creatinine >2 or creatinine clearance <50cc/hr.

• Fractional shortening by echocardiogram not within normal limits per institution

• Pulmonary function: DLCO less that 50% of normal predicted, corrected for anemia

• Prior allogeneic transplant