NCT00133367

Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus

Phase II Study of Sequential Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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, 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.

Conditions

• Multiple Myeloma
• Non-Hodgkin's Lymphoma
• Hodgkin's Disease
• Myelogenous Leukemia
• Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Tacrolimus	Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.
DRUG	Sirolimus	Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.
DRUG	G-CSF	Given starting on day 5 after transplant until the subjects white blood cell count recovers.
DRUG	Antithymocyte globulin	Given intravenously for 4 days before transplant (days 7, 5, 3, 1).
DRUG	Thymoglobulin	Given intravenously for 4 days before transplant (days 7, 5, 3, 1).
DRUG	Fludarabine	Given intravenously for six days prior to transplant (days 8,7,6,5,4,3).
DRUG	Melphalan	Given intravenously on day 2 before transplant.

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-11-01
• Completion: 2011-11-01
• First posted: 2005-08-23
• Last updated: 2016-07-25

Locations

2 sites across 1 country: United States