In-Vivo Activated T-Cell Depletion to Prevent GVHD
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|ClinicalTrials.gov Identifier: NCT00594308|
Recruitment Status : Terminated (Treatment ineffective)
First Posted : January 15, 2008
Results First Posted : March 20, 2012
Last Update Posted : October 6, 2014
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).
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Cyclophosphamide Drug: Fludarabine Drug: Cyclosporine Drug: Mycophenolate mofetil Drug: Basiliximab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||In-Vivo Activated T-Cell Depletion to Prevent GVHD|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2008|
- 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.
- Number of Patients With Acute Grade II-IV GVHD [ Time Frame: 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.
- 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 ]
- 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) ]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) ]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 ]Number of patients who died due to transplant related toxicities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594308
|United States, Indiana|
|Indiana Universtiy Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Robert Nelson, MD||Indiana Universtiy School of Medicine|