Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease
To determine whether treatment with ustekinumab will alter the ratio of Treg/total CD4+ cells in peripheral blood at day 30 post-hematopoietic cell transplantation (HCT).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation|
- Treg/total CD4+ ratio [ Time Frame: 30 days post transplant ] [ Designated as safety issue: No ]Treg/total CD4+ ratio at day 30 following HCT
- Incidence of Acute Graft vs. Host Disease [ Time Frame: 100 days post transplant ] [ Designated as safety issue: No ]Incidence of acute graft vs. host disease will be characterized weekly from day of transplant to day 100 using the 1995 updated grading scheme for GVHD developed by Glucksberg, et al.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||October 2015|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Ustekinumab, Tacrolimus and Sirolimus
One subcutaneous injection will be administered on day -1 and repeated on day +20 after transplant
Other Name: STELARA
Placebo Comparator: Placebo
Placebo Tacrolimus, and Sirolimus
Subcutaneous injection of sterile saline (identical volume to that of ustekinumab) will be administered via the identical route and schedule as ustekinumab.
This is a comparative study to assess the biologic and clinical activity of the agent ustekinumab when given in concert with our established regimen of SIR/TAC. Patients will be randomly assigned between the standard regimen of tacrolimus/sirolimus (TAC/SIR + placebo) vs. the investigational regimen of tacrolimus/sirolimus/ustekinumab (TAC/SIR/U) in a 1:1 scheme.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713400
|United States, Florida|
|H Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Joseph Pidala, MD, MS||H. Lee Moffitt Cancer Center and Research Institute|