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Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed By Donor Bone Marrow Transplant, Cyclophosphamide, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Immunodeficiency or Noncancerous Inherited Disorders

Complete title: HLA-Haploidentical Related Marrow Grafts for the Treatment of Immunodeficiency and Other Nonmalignant Disorders Using Conditioning with Low-Dose Cyclophosphamide, 200 cGy TBI and Fludarabine; Postgrafting Immunosuppression Will Consist of a Single Low Dose of Cyclophosphamide, MMF and Tacrolimus.

Research Study Number       2032.00
    
Principal Investigator       Lauri Burroughs, MD
    
Phase       II

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Research Study Description

The purpose of this study is to determine the safety of non-myeloablative conditioning and stem cell transplantation for patients with non-malignant inherited disorders who do not have a genetically matched donor. Participants in this study will receive bone marrow donated by a family member whose tissue type is genetically only a partial match. Non-myeloablative conditioning (the chemotherapy and radiation given just before a transplant) uses lower doses of chemotherapy and radiation than conventional conditioning.

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.

Participants will be in the study for at least one year, and will come to the SCCA clinic for treatment for about four months (about one month before the transplant and three months after the transplant).

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.

• Non-malignant disease treatable by allogeneic stem cell transplantation.

• Patient is at high risk of having toxic side effects, or is ineligible for a conventional myeloablative stem cell transplantation,

• Patient does not have a genetically matched (HLA-matched, related or unrelated) donor.

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

• Patients with aplastic anemia, Fanconi anemia

• Patients with HLA-matched (genetically matched) related or unrelated donors

• Patients with HIV

• Patients who are female and are pregnant or breastfeeding

Other exclusion criteria may apply.



Research Study Number       2032.00
    
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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  • Talk to your health care providers first before making decisions about your health care.
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