drugset / 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

NCT01119066

Phase 2 Completed 422 enrolled Memorial Sloan Kettering Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-05-03
Primary completion
2021-03-30
Completion
2021-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 0.8 mg/kg
Subject Clofarabine Other / unclassified 20 mg/m2
Subject Clofarabine Other / unclassified 30 mg/m2
Subject Cyclophosphamide Other / unclassified 60 mg/kg
Subject Fludarabine Small molecule 25 mg/m2
Subject Melphalan Small molecule 70 mg/m2
Subject Thiotepa Other / unclassified 5 mg/kg
Subject Thiotepa Other / unclassified 10 mg/kg