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A clinical trial to assess safety and two regimens of (MEDI-507) a drug given to stem cell and bone marrow recipients who have a mid-grade acute Graft-versus-Host Disease.
To assess the safety of two regimens of MEDI-507 administered to stem cell and bone marrow allograft recipients who have at least grade II acute GVHD and who have not achieved a satisfactory response to at least three days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or its equivalent).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MEDI-507 |
|
| 2 | Experimental | MEDI-507 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-507 | Drug | 0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of normal saline on Days 16, 23, 30, and 37. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety was assessed by the direct observation of patients, medical history, and clinical laboratory evaluation to determine the incidence of patients experiencing AEs. | Day 0-60 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics, Lymphocyte Phenotype and CD2 Receptor Occupancy Pharmacodynamics | Study Days 12 and 44 |
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Inclusion Criteria:
Exclusion Criteria:
Ø documented or presumed significant active infection Ø pregnancy or nursing mother Ø evidence of infection with HIV-1, hepatitis B or C virus Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator
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| Name | Affiliation | Role |
|---|---|---|
| J. Bruce McClain, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| University of Colorado Health Sciences Center |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C544394 | siplizumab |
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| MEDI-507 | Drug | 0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of MEDI-507 on Days 16, 23, 30, and 37. |
|
| Denver |
| Colorado |
| 80262 |
| United States |
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| University Hospital-University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| Western Pennsylvania Hospital - Western Pennsylvania Cancer Center | Pittsburgh | Pennsylvania | 15224 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| South Texas Cancer Institute at Methodist Hospital | San Antonio | Texas | 78229 | United States |