116
Participants
Start Date
January 31, 2013
Primary Completion Date
May 21, 2019
Study Completion Date
December 31, 2019
Transplants from 8/8-matched Unrelated donors
"* Myeloablative conditioning~ 1. Total body irradiation; 165 cGy, every 12 hours, 8 doses, days -7 to -4 (total 1320 cGy)~ 2. Cyclophosphamide; 60 mg/kg/day, IV for 30 minutes, days -3 to -2 (total 120 mg/kg)~ 3. Antithymocyte globulin (ATG); 1.25 mg/kg/day, IV for 6 hours, days -3 to -2, (total 2.5 mg/kg)~* Reduced-intensity conditioning; older patients (age \> 55 years) and/or patients with comorbidities~ 1. Fludarabine; 30 mg/m\^2/day, IV for 1 hour, days -8 to -4 (total 150 mg/m\^2)~ 2. Busulfex; 3.2 mg/kg/day, IV for 3 hours, days -3 to -2 (total 6.4 mg/kg)~ 3. Total body irradiation; 200 cGy, every 12 hours 2 doses, days -1 (total 400 cGy)~ 4. ATG; 1.25 mg/kg/day, IV for 6 hours, days -3 to -2, (total 2.5 mg/kg)~* GVHD prophylaxis~ 1. Tacrolimus; 0.03 mg/kg/day, IV for 24 hours from day -1 (0.12 mg/kg/day, PO, if tolerable)~ 2. Methotrexate; 5 mg/m\^2/day, IV push, days +1, +3, +6, +11"
Transplants from family-mismatched/haploidentical donors
"* Reduced-intensity conditioning~ 1. Total body irradiation; 200 cGy, every 12 hours, 4 doses, days -9 to -8 (total 800 cGy)~ 2. Fludarabine; 30 mg/m\^2/day, IV for 1 hour, days -7 to -3 (total 150 mg/m\^2)~ 3. Busulfex; 3.2 mg/kg/day, IV for 3 hours, days -6 to -5 (total 6.4 mg/kg)~ 4. ATG; 1.25 mg/kg/day, IV for 6 hours, days -4 to -1 (total 5.0 mg/kg)~* GVHD prophylaxis~ 1. Tacrolimus; 0.03 mg/kg/day, IV for 24 hours from day -1 (0.12 mg/kg/day, PO, if tolerable)~ 2. Methotrexate; 5 mg/m\^2/day, IV push, days +1, +3, +6, +11"
Catholic Blood and Marrow Transplantation Center, Seoul St. Mary's Hospital, Seoul
Byung-Sik Cho
OTHER