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Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed By a Donor Stem Cell Transplant in Treating Patients With Immunodeficiency or Other Nonmalignant Inherited Disorders

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 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.

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 October, 2013

Sponsored by: Fred Hutchinson Cancer Research Center
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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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