In-Vivo Activated T-Cell Depletion to Prevent GVHD

Not Applicable

Terminated

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

Brief 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).

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Number of Patients With Acute Grade II-IV GVHD	until 30 days after stem cell transplant	Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.

Secondary Outcome Measures

Name	Time	Method
Time to Resolution of Cytopenias: Platelet Transfusion Independence	From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)	Average number of days per patient for resolution of cytopenias.
Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.	up to 2 years after stem cell transplant	Number of patients who died due to transplant related toxicities
Number of Days for Absolute Neutrophil Count to Recover	From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)	Average number of day per patient for absolute neutrophil count to recover(\> 500/mm3 for 3 consecutive days).
Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).	until 30 days after stem cell transplant