Trial record 1 of 18 for:
Ustekinumab | Open Studies
Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease
This study is currently recruiting participants.
Verified March 2013 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
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: March 14, 2013
Last verified: March 2013
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Purpose
To determine whether treatment with ustekinumab will alter the ratio of Treg/total CD4+ cells in peripheral blood at day 30 post-HCT
| Condition | Intervention |
|---|---|
|
Acute GVH Disease |
Drug: Ustekinumab Drug: Placebo |
| 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: | 38 |
| 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
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:
- LVEF >/= 45% by MUGA scan
- FEV1, FVC, and 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 ClinicalTrials.gov identifier: NCT01713400
Contacts
| Contact: Joseph Pidala, MD, MS | 813-745-2556 | joseph.pidala@moffitt.org |
| Contact: Erika Pugh, BS | 813-745-2721 | erika.pugh@moffitt.org |
Locations
| United States, Florida | |
| H Lee Moffitt Cancer Center & Research Institute | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Joseph Pidala, MD, MS 813-745-5236 joseph.pidala@moffitt.org | |
| Contact: Erika Pugh 813-745-2721 erika.pugh@moffitt.org | |
| 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
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: | March 14, 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 GVHD |
Additional relevant MeSH terms:
|
Graft vs Host Disease Immune System Diseases Sirolimus Everolimus Tacrolimus 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 |
ClinicalTrials.gov processed this record on May 19, 2013