Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related Donors

Location:

Rochester, Minn.

Trial status:
Open for Enrollment
Why is this study being done?

The objective of this trial is to make an initial assessment for this new treatment regimen and to show it is equal or superior to the current standard practice. With this initial assessment be hope to gain information suggesting further study of this regimen or discontinuation of this regimen before exposing large numbers of patients to this new treatment option. We also will gain experience with this new regimen giving insights as to possible modifications in dosing and monitoring and selection of patients for future treatment in case of positive results. For this initial study we plan to enroll up to 24 patients.

Who is eligible to participate?

Inclusion Criteria: - Diagnosis of SAA based on bone marrow aspirate and biopsy results. Failure to respond to immunosuppressive therapy. Lack of an HLA identical family member. - A 6/6 or 5/6 HLA matched unrelated donor or a 5/6 matched related donor available after high resolution typing. Exclusion Criteria: - Patients with Aplastic anemia and active infection must be treated to maximally resolve this problem before beginning the conditioning regimen. - HIV seropositive patients - Patients who have clonal cytogenetic abnormalities or a myelodysplastic syndrome. - Patient greater than 60 years of age. - Women who are pregnant or nursing. - Patients with active hepatitis - Patients with severe cardiac dysfunction defined as shortening fraction <25%. - Patients with severe renal dysfunction defined as creatinine clearance <40ml/mim/1.73m2. - Patient with severe pulmonary dysfunction with FEV1, FVC and DLCO 40% of predicted or 3 SD below normal.

Last updated:
1/27/2014
NCT ID:
NCT00578266
IRB Number:
06-006216