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| Sponsors and Collaborators: |
Yale University Wyeth |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00623012 |
Purpose
The objective of this study is to evaluate feasibility, toxicity and efficacy of using Rapamycin to prevent chronic graft-versus-host-disease (GVHD) during and after the tacrolimus taper in recipients of allogeneic stem cell transplant.
Our hypothesis is that the T cells that can cause chronic GVHD are suppressed but not eliminated by calcineurin inhibitors. Therefore, when the calcineurin inhibitors are discontinued, the T cells may get activated and result in GVHD. Rapamycin on the other hand will allow anergy formation and thus when discontinued, T cells should not get activated. The schedule is designed to have therapeutic rapamycin levels as the tacrolimus is discontinued. Rapamycin will be continued as a single agent for additional 4 weeks and be tapered off in two weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft Versus Host Disease |
Drug: Rapamycin Drug: Tacrolimus |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | Rapamycin for Prevention of Chronic Graft-Versus-Host Disease |
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Rapamycin
Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.
Drug: Tacrolimus
Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Noelle Sowers, RN | 203-785-2442 | noelle.sowers@yale.edu |
| Contact: Donna LaCivita | 203-737-2579 | donna.lacivita@yale.edu |
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Principal Investigator: | Stuart Seropian, M.D. | Yale University |
More Information
| Responsible Party: | Yale University School of Medicine ( Stuart Seropian, M.D. Principal Investigator ) |
| Study ID Numbers: | 0702002350 |
| Study First Received: | February 13, 2008 |
| Last Updated: | June 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00623012 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Sirolimus Graft Versus Host Disease Anti-Infective Agents Anti-Bacterial Agents Immunologic Factors |
Antifungal Agents Graft vs Host Disease Tacrolimus Immunosuppressive Agents Homologous Wasting Disease |
|
Sirolimus Anti-Infective Agents Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Tacrolimus |
Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Antifungal Agents Graft vs Host Disease |
