Rapamycin for Prevention of Chronic Graft-Versus-Host Disease
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|ClinicalTrials.gov Identifier: NCT00623012|
Recruitment Status : Terminated (Low accrual)
First Posted : February 25, 2008
Results First Posted : February 3, 2017
Last Update Posted : February 3, 2017
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 or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease||Drug: Rapamycin Drug: Tacrolimus||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rapamycin for Prevention of Chronic Graft-Versus-Host Disease|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
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.
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
- Improvement of the Rate of Graft Versus Host Disease (GVHD) From the Accepted Rate of 74%. [ Time Frame: up to 8 weeks ]Percentage of patients free from graft versus host disease
- Overall Survival [ Time Frame: up to 10 weeks ]achieved overall survival in regard to leukemia
- Disease Free Survival [ Time Frame: up to 10 weeks ]achieved disease free in regard to leukemia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623012
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Stuart Seropian, M.D.||Yale University|