This study involves the use of a drug called Thymoglobulin, which is approved in the USA to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection. Thymoglobulin is not approved for the treatment or prophylaxis of graft versus host disease in bone marrow transplantation. This study is to evaluate two (2) doses of Thymoglobulin and its safety and effectiveness when used with a "myeloablative" conditioning regimen prior to receiving a stem cell transplant (also called bone marrow transplantation) from a matched, related donor. A myeloablative regimen is typically composed of chemotherapy and radiation and destroys the subject's existing bone marrow. Subjects meeting all inclusion and exclusion criteria and who have a relative with matching (genetically similar) stem cells who are also willing to donate them (i.e. matched-related-donor) are eligible to participate in this study. Following myeloablative therapy, the donor's cells are then transplanted (i.e. infused) into the subject's blood stream. One of the most common complications of this type of transplant is graft-versus-host disease (GvHD). This is a condition where the transplanted donor cells attack the transplant recipient's body. Treatments, such as cyclosporine, are used to minimize the risk of GvHD following stem cell transplantation. To enter this study, subjects must be having a matched-related donor stem cell transplant. If a subject qualifies for entry into this study, he/she will be assigned to receive Thymoglobulin at a dose of 4.5 mg/kg or 8.5 mg/kg. The treatment assignment is random and is not chosen by the subject or their physician. Subjects are admitted to the hospital for the transplant procedure and are treated with Thymoglobulin over 3-5 days just prior to receiving the donor stem cells. The subject will also receive standard GvHD prophylaxis with cyclosporine. Methotrexate, which is commonly used by transplant centers to minimize the risk of GvHD, will not be used in this study. Subjects will be monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurs at month 1, 100 days and 6 months following the transplant. Approximately 60 study subjects from approximately 14 transplant centers in the United States and Canada will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
60
total dose 4.5 mg/kg
total dose 8.5 mg/kg
University of Alabama-Birmingham Hospital
Birmingham, Alabama, United States
UCLA Medical Center
Los Angeles, California, United States
Shands at the University of Florida, Division of Hematology/Oncology
Gainesville, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Massachusetts General Hospital Cox Bldg Room 640
Boston, Massachusetts, United States
Dana Farber Cancer Institute Dana 1B11
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center KS121
Brookline, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
...and 4 more locations
Incidence of Grade II to IV acute GvHD in the first 100 days after transplant.
Time frame: 100 days
Incidence of treatment related adverse events and serious adverse events at 100 days and 6 months post transplant
Time frame: 100 days and 6 months
Patient survival at 100 days and 6 months after transplant
Time frame: 100 days and 6 months
transplant related mortality at 100 days or 6 months after transplant
Time frame: 100 days and 6 months
severity and outcomes of acute GvHD
Time frame: 100 days & 6 mos
any events of infection at 100 days and 6 months after transplant
Time frame: 100 days and 6 months
incidence (or absence) of mucositis
Time frame: continuous
how many days in the first month after transplant certain types of narcotics are used to reduce pain
Time frame: 30days
whether the subject's blood counts after transplant reach a stable level and how quickly
Time frame: Continuous
incidence of re-hospitalization in the first 6 months after transplant
Time frame: 6 months
any recurrence of the subject's leukemic disease, and how long the subject was able to stay in remission
Time frame: Continuous
incidence and severity of chronic GvHD, and the extent, after 100 days and 6 months after transplant
Time frame: 100 days and 6 months
Disease free survival
Time frame: 100 days and 6 months
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