This trial is active, not recruiting.

Condition graft vs. host disease
Treatments ustekinumab, placebo
Phase phase 2
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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Ustekinumab, Tacrolimus and Sirolimus
ustekinumab STELARA
One subcutaneous injection will be administered on day -1 and repeated on day +20 after transplant
(Placebo Comparator)
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.

Primary Outcomes

Treg/total CD4+ ratio
time frame: 30 days post transplant

Secondary Outcomes

Incidence of Acute Graft vs. Host Disease
time frame: 100 days post transplant

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.