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Nonapeptide-1

Melanostatine-5, White 05

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Studies 4
Trials 100
Completed PHASE2 INTERVENTIONAL NCT00133367

Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus

View on ClinicalTrials.gov Updated Dec 15, 2025

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, 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.

Interventions

Name: Tacrolimus
Type: DRUG
Description: 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.
Name: Sirolimus
Type: DRUG
Description: 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.
Name: G-CSF
Type: DRUG
Description: Given starting on day 5 after transplant until the subjects white blood cell count recovers.
Name: Antithymocyte globulin
Type: DRUG
Description: Given intravenously for 4 days before transplant (days 7, 5, 3, 1).
Name: Thymoglobulin
Type: DRUG
Description: Given intravenously for 4 days before transplant (days 7, 5, 3, 1).
Name: Fludarabine
Type: DRUG
Description: Given intravenously for six days prior to transplant (days 8,7,6,5,4,3).
Name: Melphalan
Type: DRUG
Description: Given intravenously on day 2 before transplant.

Primary Outcomes

Measure: To determine the effectiveness of tacrolimus and sirolimus in preventing graft versus host disease
TimeFrame: 2 years
Description:

Trial Information

NCT ID

NCT00133367

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Massachusetts General Hospital

Last Updated

December 15, 2025