drugset / Trial / NCT00553098
Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by a Donor Stem Cell Transplant in Treating Patients With Immunodeficiency or Other Nonmalignant Inherited Disorders
Phase 2
Completed
29 enrolled
Fred Hutchinson Cancer Center
National Cancer Institute (NCI) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase II trial studies fludarabine phosphate and total-body irradiation with or without alemtuzumab followed by donor stem cell transplant to see how well it works in treating patients with immunodeficiency or other nonmalignant inherited disorders. Giving chemotherapy, such as fludarabine phosphate, a monoclonal antibody such as alemtuzumab, and radiation therapy before a donor stem cell transplant helps stop the growth of abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining abnormal cells.
Timeline
- Start
- 2006-06
- Primary completion
- 2015-03
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alemtuzumab | Monoclonal antibody | — | Intravenous |
| Background | Cyclosporine | Peptide | — | Oral |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | — | Oral |