At a glance
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A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes
In Brief
A Phase 2 clinical trial evaluating Bone marrow transplant, Thymoglobulin, and 6 other interventions for Severe Aplastic Anemia and Bone Marrow Failure Syndromes. Completed, enrolled 18 participants across 2 sites.
Detailed Summary
Our primary objective is to determine if it is feasible for SAA patients to be transplanted using non-myeloablative conditioning and post transplantation cyclophosphamide with partially HLA-mismatched donors.
Study Details
Timeline
Interventions
Day 0
0.5 mg/kg IV on Day -9 2 mg/kg IV on Days -8, -7
30 mg/M2 IV on days -6 to -2
14.5 mg/kg IV on days -6, -5, 3, 4
200 cGy on day -1
40 mg/kg IV on days 3, 4
For patients 18 years or older, tacrolimus will be given per institutional standards; may be increased or later changed to a PO BID schedule. Treatment to continue until Day 365 or longer if GVHD present
15 mg/kg PO/IV TID beginning on day 5 through day 35