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To determine what side effects and what clinical effect, if any, the administration of this investigational product, IDEC-114 in combination with Rituxan® [Rituxan® as a single agent is approved by the United States Food and Drug Administration (FDA) to treat patients with relapsed or refractory follicular NHL], has in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDEC-114 | Drug | Dose Group 1 - 125 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study | March 2010 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate PK | March 2010 | |
| To evaluate efficacy | March 2010 | |
| To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Birmingham | Alabama | 35294 | United States | ||
| Research site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17470451 | Background | Leonard JP, Friedberg JW, Younes A, Fisher D, Gordon LI, Moore J, Czuczman M, Miller T, Stiff P, Cheson BD, Forero-Torres A, Chieffo N, McKinney B, Finucane D, Molina A. A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma. Ann Oncol. 2007 Jul;18(7):1216-23. doi: 10.1093/annonc/mdm114. Epub 2007 Apr 29. |
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|
| March 2010 |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Research site | Los Angeles | California | 90095 | United States |
| Research site | Newport Beach | California | 92658 | United States |
| Research site | San Diego | California | 92121 | United States |
| Research site | Aurora | Colorado | 80010 | United States |
| Research site | Washington D.C. | District of Columbia | 20007 | United States |
| Research site | Tampa Bay | Florida | 33612 | United States |
| Research site | Chicago | Illinois | 60611 | United States |
| Research site | Maywood | Illinois | 60153 | United States |
| Research site | Boston | Massachusetts | 2115 | United States |
| Research site | Detroit | Michigan | 48202 | United States |
| Research site | Rochester | Minnesota | 55905 | United States |
| Research site | Omaha | Nebraska | 68198 | United States |
| Research site | Buffalo | New York | 14263 | United States |
| Research site | New York | New York | 10021 | United States |
| Research site | Rochester | New York | 14642 | United States |
| Research site | Durham | North Carolina | 27710 | United States |
| Research site | Philadelphia | Pennsylvania | 1906 | United States |
| Research site | Columbia | South Carolina | 29210 | United States |
| Research site | Houston | Texas | 77030 | United States |
| Research site | Charlottesville | Virginia | 22908 | United States |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| 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 |
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| ID | Term |
|---|---|
| C437823 | galiximab |
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