Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus
The purpose of this study is to measure the effectiveness of 2 drugs, tacrolimus and sirolimus, in preventing graft versus host disease (GVHD) after treatment with chemotherapy followed by donor cord blood transplantation.
Drug: Antithymocyte globulin
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Sequential Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis|
- To determine the effectiveness of tacrolimus and sirolimus in preventing graft versus host disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To evaluate the days to neutrophil engraftment and platelet engraftment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To evaluate the relapse rate and overall disease free survival [ Time Frame: TBD ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||November 2011|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
- The chemotherapy portion of the study involves the intravenous administration of fludarabine, for six days (Days 8, 7, 6, 5,4, and 3) before transplant, melphalan, for one day (Day 2) before transplant. Antithymocyte globulin, or thymoglobulin, will be given IV daily for 4 days (days 7, 5, 3, and 1 before transplant). This drug also helps to suppress the immune system, allowing the cord blood cells to grow and reproduce.
- Immunosuppression therapy consists of the drugs tacrolimus and sirolimus. The patient will receive these 3 days before the transplant and every day for 3-6 months after transplant. After the first 100 days post transplant, the doses of tacrolimus and sirolimus will begin to be reduced with the goal of having the patient off both drugs by 6-9 months after transplant.
- After completion of conditioning therapy described above, the patient will receive 2 cord blood units 1-6 hours apart. To help with engraftment, the patient will also receive G-CSF starting on day five after transplant, until the patients white blood cells recover.
- Follow-up visits will continue every 6 months after the last treatment dose and will last up to 2 years.
- Blood tests will be drawn frequently to test whether the donor's immune cells have engrafted as well as to test the levels of Tacrolimus and Sirolimus.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Karen K Ballen, MD||Massachusetts General Hospital|