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This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone.
Secondary objectives include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDX-060 plus standard of care | Experimental | MDX-060 in combination with gemcitabine |
|
| Standard of care | Active Comparator | Gemcitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDX-060 | Drug | anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Day 50/57 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Day 50/57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medarex Medical Monitor | Medarex | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope, National Medical Center | Duarte | California | 91010 | United States | ||
| California Oncology of the Central Valley |
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| Fresno |
| California |
| 93710 |
| United States |
| University of California, San Diego/Moores UCSD Cancer Center | La Jolla | California | 92093-0698 | United States |
| H. Lee Moffitt Cancer & Research Institute | Tampa | Florida | 33612 | United States |
| Rush Cancer Institute | Chicago | Illinois | 60612 | United States |
| St. Francis Hospital Center | Beech Grove | Indiana | 46107 | United States |
| American Health Network of Indiana | Indianapolis | Indiana | 46237 | United States |
| Division of Hematology/Oncology, Tufts-New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Nevada Cancer Institute | Las Vegas | Nevada | 89135 | United States |
| The Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Roswell Park Cancer Center | Buffalo | New York | 14263 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Carolina BioOncology Institute, PLLC | Huntersville | North Carolina | 28078 | United States |
| M.D. Anderson Cancer Center, The University of Texas | Houston | Texas | 77030 | United States |
| Mary Babb Randolph Cancer Center | Morgantown | West Virginia | 26506-9162 | United States |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C510955 | iratumumab |
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