HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT01119066

HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

The purpose of this study is to find out the effects of using a system called CliniMACS to remove Tcells from blood stem cells. Removing T-cells may help stop a side effect called Graft-Versus-Host Disease (GVHD). Some studies have been done with CliniMACS, but the Food and Drug Administration (FDA) has not yet approved it.

Status: 
Recruiting
Study Date: 
Sat, 05/01/2010 to Mon, 05/01/2017
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Radiation: total body irradiation dose of 1375-1500 cGy Drug: Thiotepa 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Drug: Cyclophosphamide 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated). Drug: Busulfan 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics Drug: Melphalan 70mg/m2/day x 2 Drug: Fludarabine 25mg/m2/ day x 5 Drug: Clofarabine 20mg/m2/ day x 5 (or, for children <18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval) Procedure: (CliniMACS) T-cell depleted PBSC Transplant