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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Low dose | Experimental | total dose 4.5 mg/kg Thymoglobulin |
|
| 2 High dose | Experimental | total dose 8.5 mg/kg Thymoglobulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] | Biological | total dose 4.5 mg/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade II to IV acute GvHD in the first 100 days after transplant. | 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment related adverse events and serious adverse events at 100 days and 6 months post transplant | 100 days and 6 months | |
| Patient survival at 100 days and 6 months after transplant | 100 days and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama-Birmingham Hospital | Birmingham | Alabama | 35249 | United States | ||
| UCLA Medical Center |
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| Label | URL |
|---|---|
| US FDA Approved Full Prescribing Information for Thymoglobulin® | View source |
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| Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] |
| Biological |
total dose 8.5 mg/kg |
|
| transplant related mortality at 100 days or 6 months after transplant | 100 days and 6 months |
| severity and outcomes of acute GvHD | 100 days & 6 mos |
| any events of infection at 100 days and 6 months after transplant | 100 days and 6 months |
| incidence (or absence) of mucositis | continuous |
| how many days in the first month after transplant certain types of narcotics are used to reduce pain | 30days |
| whether the subject's blood counts after transplant reach a stable level and how quickly | Continuous |
| incidence of re-hospitalization in the first 6 months after transplant | 6 months |
| any recurrence of the subject's leukemic disease, and how long the subject was able to stay in remission | Continuous |
| incidence and severity of chronic GvHD, and the extent, after 100 days and 6 months after transplant | 100 days and 6 months |
| Disease free survival | 100 days and 6 months |
| Los Angeles |
| California |
| 90095 |
| United States |
| Shands at the University of Florida, Division of Hematology/Oncology | Gainesville | Florida | 32610 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Massachusetts General Hospital Cox Bldg Room 640 | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Institute Dana 1B11 | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center KS121 | Brookline | Massachusetts | 02215 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| The Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Ottawa Hospital - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Hospital, University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C512542 | thymoglobulin |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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