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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Gateway for Cancer Research
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01713400
First received: October 22, 2012
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

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.


Enrollment: 54
Study Start Date: February 2013
Estimated Study Completion Date: April 2015
Primary Completion Date: October 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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713400

Locations
United States, Florida
H Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Gateway for Cancer Research
Investigators
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
ClinicalTrials.gov Identifier: NCT01713400     History of Changes
Other Study ID Numbers: MCC-16743
Study First Received: October 22, 2012
Last Updated: October 27, 2014
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
Everolimus
Sirolimus
Tacrolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014