Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus
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|ClinicalTrials.gov Identifier: NCT00133367|
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : July 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Non-Hodgkin's Lymphoma Hodgkin's Disease Myelogenous Leukemia Lymphoblastic Leukemia||Drug: Tacrolimus Drug: Sirolimus Drug: G-CSF Drug: Antithymocyte globulin Drug: Thymoglobulin Drug: Fludarabine Drug: Melphalan||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Sequential Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2011|
- To determine the effectiveness of tacrolimus and sirolimus in preventing graft versus host disease [ Time Frame: 2 years ]
- To evaluate the days to neutrophil engraftment and platelet engraftment [ Time Frame: 2 years ]
- To evaluate the relapse rate and overall disease free survival
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): NCT00133367
|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|