At a glance
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A Phase II Trial of Non-Myeloablative (NMA) Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Donor (MUD) Bone Marrow for Newly Diagnosed Patients With Severe Aplastic Anemia
In Brief
A Phase 2 clinical trial evaluating Thymoglobulin, Fludarabine, and 4 other interventions for Severe Aplastic Anemia and 3 related conditions. Completed, enrolled 21 participants across 1 site.
Detailed Summary
Our primary objective is to determine if it is feasible for previously untreated severe aplastic anemia (SAA) patients to be transplanted using non-myeloablative conditioning and post transplantation cyclophosphamide.
Study Details
Timeline
Interventions
Day -9: 0.5 mg/kg Days -8 and -7: 2 mg/kg daily
Days -6 through -2: 30 mg/m\^2 IV daily
Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily
Day -1: 200 centigray (cGy) in a single fraction
Start on Day 5 through Day 365
Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)