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Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease

This study is currently recruiting participants.
Verified December 2013 by H. Lee Moffitt Cancer Center and Research Institute
Gateway for Cancer Research
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute Identifier:
First received: October 22, 2012
Last updated: December 20, 2013
Last verified: December 2013

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).

Condition Intervention Phase
Graft vs. Host Disease
Drug: Ustekinumab
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Treg/total CD4+ ratio [ Time Frame: 30 days post transplant ] [ Designated as safety issue: No ]
    Treg/total CD4+ ratio at day 30 following HCT

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 75
Study Start Date: February 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ustekinumab
Ustekinumab, Tacrolimus and Sirolimus
Drug: Ustekinumab
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
Drug: Placebo
Subcutaneous injection of sterile saline (identical volume to that of ustekinumab) will be administered via the identical route and schedule as ustekinumab.

Detailed 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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01713400

Contact: Joseph Pidala, MD, MS 813-745-2556
Contact: Erika Elmer, BS 813-745-2721

United States, Florida
H Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Joseph Pidala, MD, MS    813-745-5236   
Contact: Erika Elmer    813-745-2721   
Sub-Investigator: Claudio Anasetti, MD         
Sub-Investigator: Melissa Alsina, MD         
Sub-Investigator: Teresa Field, MD, PhD         
Sub-Investigator: Ernesto Ayala, MD         
Sub-Investigator: Hugo Fernandez, MD         
Sub-Investigator: Lia Perez, MD         
Sub-Investigator: Leonel Ochoa, MD         
Sub-Investigator: William Janssen, PhD         
Sub-Investigator: Marcie Tomblyn, MD, MS         
Sub-Investigator: Fred Locke, MD         
Sub-Investigator: Taiga Nishihori, MD         
Sub-Investigator: Brian Betts, MD         
Sub-Investigator: Mohamed Kharfan-Dabaja, MD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Gateway for Cancer Research
Principal Investigator: Joseph Pidala, MD, MS H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT01713400     History of Changes
Other Study ID Numbers: MCC-16743
Study First Received: October 22, 2012
Last Updated: December 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Acute Graft vs. Host Disease (aGVHD)
Graft vs. Host Disease (GVHD)

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Antibodies, Monoclonal
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents processed this record on April 17, 2014