Rapamycin for Prevention of Chronic Graft-Versus-Host Disease
This study is currently recruiting participants.
Verified June 2009 by Yale University
Sponsor:
Yale University
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00623012
First received: February 13, 2008
Last updated: June 5, 2009
Last verified: June 2009
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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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Rapamycin for Prevention of Chronic Graft-Versus-Host Disease |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- Improvement of the rate of graft versus host disease (GVHD) from the accepted rate of 74%. [ Time Frame: Upon completion of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival and disease free survival [ Time Frame: Upon completion of study ] [ Designated as safety issue: No ]
| 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 |
|---|---|
| Experimental: 1 |
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.
Other Names:
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.
Other Name: Prograf
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥18 years
- Received an allogeneic MSD or MUD PBSCT
- 24 weeks post SCT
- Currently on Tacrolimus for GVHD prophylaxis
- Deemed eligible for tapering off of Tacrolimus by primary BMT physician
Exclusion Criteria:
- Relapsed Disease
- Ongoing GVHD
- Patients whose immunosuppression is being stopped early to treat or prevent relapse
- Patients with pure red cell aplasia due to ABO mismatched donor
- Ongoing thrombotic microangiopathy
- Allergy to rapamycin
- Women of childbearing potential must have a negative serum pregnancy test performed prior to the start of treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623012
Contacts
| Contact: Noelle Sowers, RN | 203-785-2442 | noelle.sowers@yale.edu |
| Contact: Donna LaCivita | 203-737-2579 | donna.lacivita@yale.edu |
Locations
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
Sponsors and Collaborators
Yale University
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Principal Investigator: | Stuart Seropian, M.D. | Yale University |
More Information
No publications provided
| Responsible Party: | Stuart Seropian, M.D. Principal Investigator, Yale University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00623012 History of Changes |
| Other Study ID Numbers: | 0702002350 |
| Study First Received: | February 13, 2008 |
| Last Updated: | June 5, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Graft vs Host Disease Immune System Diseases Sirolimus Everolimus Tacrolimus 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 June 18, 2013