In-Vivo Activated T-Cell Depletion to Prevent GVHD
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).
Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Chronic Lymphocytic Leukemia
Drug: Mycophenolate mofetil
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||In-Vivo Activated T-Cell Depletion to Prevent GVHD|
- Number of Patients With Acute Grade II-IV GVHD [ Time Frame: until 30 days after stem cell transplant ] [ Designated as safety issue: Yes ]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.
- Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's). [ Time Frame: until 30 days after stem cell transplant ] [ Designated as safety issue: Yes ]
- Number of Days for Absolute Neutrophil Count to Recover [ Time Frame: From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion) ] [ Designated as safety issue: Yes ]Average number of day per patient for absolute neutrophil count to recover(> 500/mm3 for 3 consecutive days).
- Time to Resolution of Cytopenias: Platelet Transfusion Independence [ Time Frame: From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion) ] [ Designated as safety issue: Yes ]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. [ Time Frame: up to 2 years after stem cell transplant ] [ Designated as safety issue: Yes ]Number of patients who died due to transplant related toxicities
|Study Start Date:||October 2007|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594308
|United States, Indiana|
|Indiana Universtiy Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Robert Nelson, MD||Indiana Universtiy School of Medicine|