drugset / Trial / NCT00597714

Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant

NCT00597714 ↗

Phase 2 Completed 264 enrolled David Rizzieri, MD
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The central hypothesis of this study is that use of a less toxic chemotherapy preparative regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell depletion with alemtuzumab for patients with high risk hematologic malignancies will allow effective control of disease and improved disease free and overall survival compared with historical expectations. Specifically, the objectives are to estimate toxicity, disease free, progression free, event free, and overall survival rates in patients treated with alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation; evaluate immune recovery following this reduced intensity allogeneic immunotherapy; develop an in vitro assay to allow patient individualized targeted dosing.

Timeline

Start
2008-02
Primary completion
2013-07
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Alemtuzumab Monoclonal antibody 20 mg Intravenous
Subject Busulfan Small molecule 130 mg/m2 Intravenous
Background Fludarabine Small molecule 40 mg/m2 Intravenous
Background Melphalan Small molecule 140 mg/m2 —