29
Participants
Start Date
November 6, 2018
Primary Completion Date
March 2, 2022
Study Completion Date
April 1, 2023
Tacrolimus
Tacrolimus will be given intravenously at a dose of 0.03 mg/kg/day starting Day -3. Subsequent dosing will be based on blood levels.
Methotrexate
Methotrexate will be administered at the doses of 15 mg/m2 IV bolus on Day +1, and 10 mg/m2 IV bolus on Days +3, +6 and +11 after hematopoietic cell infusion.
Tocilizumab
Tocilizumab will be administered intravenously (IV) at a dose of 8 mg/kg (maximum dose of 800 mg) once on the Day -1 approximately 24 hours prior to the estimated time of the hematopoietic cell infusion, and subsequently, on Day +100 (+/- 14 days, i.e., Days +86 to +114) post-alloHCT. The infusion will be administered over 60 minutes through a dedicated IV line and must not be administered by IV bolus.
Froedtert Hospital, Milwaukee
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Cancer Institute (NCI)
NIH
Medical College of Wisconsin
OTHER