Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133367
Status:
COMPLETED
Last Update Posted:
2016-07-25
First Post:
2005-08-19
Brief Title:
Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase II Study of Sequential Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The chemotherapy portion of the study involves the intravenous administration of fludarabine for six days Days 8 7 6 54 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 donors immune cells have engrafted as well as to test the levels of Tacrolimus and Sirolimus
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 donors immune cells have engrafted as well as to test the levels of Tacrolimus and Sirolimus
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None