Study:
Hematopoietic Cell Transplantation for Treatment of Patients With Primary Immunodeficiencies and Other Nonmalignant Inherited Disorders Using Low-dose TBI and Fludarabine With or Without Campath
Rationale:
n/a
Purpose:
This phase II trial is studying giving 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
Study Status: Recruiting
Recruiting:
Rabi Hanna 216-444-0663
| Condition |
Intervention |
Phase |
|
Precancerous Condition |
Biological: alemtuzumab
Drug: fludarabine phosphate
Radiation: total-body irradiation
Drug: cyclosporine
Drug: mycophenolate mofetil
Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Other: laboratory biomarker analysis |
Phase 2 |
Verified by
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
May, 2013
Sponsored by: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Information provided by: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov identifier: NCT00553098
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Lauri Burroughs., Principal Investigator