Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Related Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT00144703|
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : January 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies Myelogenous Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma Hodgkin's Disease||Drug: Sirolimus Drug: Tacrolimus||Phase 2|
- Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once per day starting 3 days before stem cell infusion. This will take place in the hospital where the patient will remain for the duration of the transplant.
- Sirolimus will continue for 9 weeks at at stable dose, then will be tapered by 1/3 on week 9 and 1/3 on week 17. It will be stopped on week 26 if there is no significant evidence of GVHD. These dose modifications will occur at home and patients will be seen weekly for the first 2 months after discharge.
- If GVHD is present, the tapering schedule wil be slower and based upon the patient's clinical condition.
- Tacrolimus will be given orally once the patient is discharged from the hospital and will be tapered at the same schedule as sirolimus. Blood levels of both tacrolimus and sirolimus will be monitored and the dose adjusted accordingly.
- During the year following stem cell transplant, blood work will be performed to evaluate the immune system and GVHD.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation|
|Study Start Date :||July 2002|
|Primary Completion Date :||November 2006|
|Study Completion Date :||November 2006|
- To determine the feasibility of using sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.
- To compare the rates of grade II-IV and III-IV acute GVHD with historical controls
- to determine the incidence of 100 day mortality after stem cell transplant using this regimen
- to determine the overall survival at 1 year after transplantation in this patient population.
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): NCT00144703
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Corey Cutler, MD, MPH||Dana-Farber Cancer Institute|