Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease
This trial is active, not recruiting.
|Condition||graft vs. host disease|
|Sponsor||H. Lee Moffitt Cancer Center and Research Institute|
|Collaborator||Gateway for Cancer Research|
|Start date||February 2013|
|End date||October 2014|
|Trial size||54 participants|
|Trial identifier||NCT01713400, MCC-16743|
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).
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, investigator)|
Treg/total CD4+ ratio
time frame: 30 days post transplant
Incidence of Acute Graft vs. Host Disease
time frame: 100 days post transplant
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - Hematologic disorder requiring allogeneic hematopoietic cell transplantation - Adequate vital organ function: - Left ventricular ejection fraction (LVEF) >/= 45% by MUGA scan - FEV1, FVC, and diffusing lung capacity oxygenation (DLCO) >/= 50% of predicted values on pulmonary function tests - Transaminases (AST, ALT) < 3 times upper limit of normal values - Creatinine clearance >/= 50 cc/min. - Performance status: Karnofsky Performance Status Score >/= 60%. Exclusion Criteria: - Active infection not controlled with appropriate antimicrobial therapy - HIV, hepatitis B, or hepatitis C infection - Sorror's co-morbidity factors with total score > 3 - Important modification to co-morbidity index calculation: DLCO will not be included in assessment of pulmonary risk, excepting those with DLCO < 50%, who will merit a score of 3 and thereby be excluded from the trial. - Anti-thymocyte globulin (ATG) as part of the conditioning regimen - Cyclophosphamide as part of the conditioning regimens
|Official title||Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation|
|Principal investigator||Joseph Pidala, MD, MS|
|Description||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.|
Call for more information