50
Participants
Start Date
July 12, 2017
Primary Completion Date
April 30, 2026
Study Completion Date
April 30, 2026
Autologous stem cell transplant
Hematopoietic stem cell transplantation
Cyclophosphamide
Days 1 and 2: Cyclophosphamide 2gm/m2/day x 2 days (total dose 4gm/m2) Day 3 until leukapheresis: G-CSF 10μg/kg/day to CD34+ \>20x104/ml then leukapheresis daily to collection goal
Cyclophosphamide
Day -6 to -3: Cyclophosphamide 50 mg/kg/day (200 mg/kg total dose)
Thymoglobulin
Day -3 to -1: 2.5 mg/kg/day (7.5 mg/kg total dose)
Methylprednisolone
Day -3 to -1: 1 gram prior to each ATG dose
Vedolizumab
Starting first day after discharge from transplant admission, then 2 weeks after 1st infusion, 4 weeks after 2nd infusion, followed by every 8 weeks for 52 weeks (8 doses)
RECRUITING
Icahn School of Medicine at Mount Sinai, New York
Lead Sponsor
Aaron Etra
OTHER