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Sponsored by: |
Stanford University |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00388362 |
To study the effectiveness of an immunosuppressive drug, sirolimus in the treatment of chronic graft versus host disease in combination with prednisone.
Condition | Intervention | Phase |
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Graft vs Host Disease |
Drug: Sirolimus Drug: Prednisone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Sirolimus as Treatment of Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease |
Estimated Enrollment: | 36 |
Study Start Date: | November 2005 |
The purpose of this trial is to study the effectiveness of an immunosuppressive drug, sirolimus, in the treatment of chronic graft versus host disease in combination with prednisone. Graft versus host disease (GVHD) is a common complication in patients who have received blood or marrow transplantation from a related or unrelated donor. Chronic GVHD occurs approximately 100 days after transplantation and is the result of the donor immune system recognizing the patient's tissues as foreign and creating harmful effects on the patient';s organs. We hope the use of sirolimus will decrease the significant disabling effects and deaths caused by chronic GVHD.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:- Histologically-confirmed active chronic GVHD >100 days following allogeneic bone marrow/peripheral blood/umbilical cord blood transplantation that has failed prior therapy. In the event that histological confirmation poses undue risk, clinical evaluation is sufficient.
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Sherry Moore 650-725-7951 shmoore@stanford.edu | |
Contact: Cancer Clinical Trials Office (650) 498-7061 | |
Principal Investigator: Laura J Johnston | |
Sub-Investigator: Judith Anne Shizuru | |
Sub-Investigator: Robert S Negrin | |
Sub-Investigator: David Miklos | |
Sub-Investigator: Robert Lowsky | |
Sub-Investigator: Ginna Laport | |
Sub-Investigator: Karl G. Blume | |
Sub-Investigator: Sally Arai | |
Sub-Investigator: Rajni Agarwal-Hashmi |
Principal Investigator: | Laura J Johnston | Stanford University |
Study ID Numbers: | BMT175, 96589, BMT175, NCT00388362 |
Study First Received: | October 12, 2006 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00388362 |
Health Authority: | United States: Institutional Review Board |
Sirolimus Prednisone Clotrimazole Graft versus host disease |
Miconazole Tioconazole Graft vs Host Disease Homologous wasting disease |
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Immune System Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Antibiotics, Antineoplastic Immunosuppressive Agents Glucocorticoids Hormones Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Antifungal Agents |