At a glance
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Optimizing Haploidentical Aplastic Anemia Transplantation (CHAMP) (BMT CTN 1502)
In Brief
A Phase 2 clinical trial evaluating Antithymocyte Globulin (ATG), Fludarabine, and 6 other interventions for Severe Aplastic Anemia. Completed, enrolled 32 participants across 28 sites.
Detailed Summary
This study is a prospective, multicenter phase II study with patients receiving haploidentical transplantation for Severe Aplastic Anemia (SAA). The primary objective is to assess overall survival (OS) at 1 year post-hematopoietic stem cell transplantation (HSCT).
Study Details
Timeline
Interventions
Administration of ATG will be 0.5 mg/kg IV on Day -9 over 6 hours and 2 mg/kg IV on Days -8 and -7 over 4 hours.
Fludarabine dose will be 30 mg/m\^2 IV daily for 5 days from Day -6 to Day -2.
Cyclophosphamide dose will be 14.5 mg/kg IV daily for 2 days (Day -6 to Day -5) prior to transplantation and 50 mg/kg IV daily for 2 days (Day +3 to Day +4) after transplantation.
TBI is to be delivered in a single dose of 200 cGy on Day -1.
Eligible patients without a fully matched related or unrelated donor available will undergo haploidentical bone marrow transplant.
Tacrolimus should be started on Day +5 and administered to maintain a level of 10-15 ng/mL.
MMF dose will be 15 mg/kg PO three times a day (TID) up to 1 gm TID (or IV equivalent) starting on Day +5.
G-CSF will be given IV or SQ starting on Day +5 at 5 mcg/kg/day until ANC is \> 1500 for 3 days.