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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

Complete title: 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®

Research Study Number       2007.00
    
Principal Investigator       Lauri Burroughs, MD
    
Phase       II

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Research Study Description

The purpose of this study is to determine whether or not a non-myeloablative conditioning regimen followed by stem cell transplantation is safe and effective as treatment of non-malignant diseases of the blood and immune system. The chemotherapy and irradiation given just before a transplant is called the conditioning regimen. A non-myeloablative conditioning regimen uses lower doses of chemotherapy and radiation than a conventional conditioning regimen.

Most of the treatment will be given at the Seattle Cancer Care Alliance (SCCA) outpatient clinic. Initial in-hospital treatment will be given at the University of Washington Medical Center or Children’s Hospital and Regional Medical Center.

Treatment on the study will last about four months (about one month before the transplant and three months after the transplant), but could be longer. Participants may be asked to return for follow-up visits 6 months, and then every year, after the transplantation.

Additional bone marrow or blood samples may be drawn at various time points for up to five years after the transplant.

Eligibility Criteria (must meet the following to participate in this study)

• Age 54 years or younger.

• Diagnosed with an immunodeficiency or other non-malignant disease that is treatable by allogeneic stem cell transplantation.

• Patients with pre-existing medical conditions or other factors that rule out treatment with conventional myeloablative stem cell transplantation.

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

• Patients with Aplastic anemia and Fanconi anemia

• 55 years or older

• Patient has HIV

• Patient is a female who is pregnant or breast-feeding

Other exclusion criteria may apply.



Research Study Number       2007.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
    

Keywords
Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT); Immunodeficiency Syndromes; Severe Combined Immunodeficiency Syndrome (SCID); Non-malignant Condition

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