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This is a Phase I trial to look at safety and how a patient's body will tolerate the treatment at different dosages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 | Experimental | 120 mg/m2 |
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| Dose level 2 | Experimental | 200 mg/m2 |
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| Dose Level 3 | Experimental | 375 mg/m2 |
|
| Dose level 1B | Experimental | 80 mg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hA20-humanized anti-CD20 antibody | Drug | once weekly iv dosing for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerance of different dose levels | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lack of immunogenicity | 8 and 12 weeks | |
| Pharmacodynamics | over 12 weeks | |
| Pharmacokinetics |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Wegener, MD, PhD | Gilead Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital/Cornell Medical Center | New York | New York | 10021 | United States | ||
| University Hospital of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20214444 | Background | Goldenberg DM, Morschhauser F, Wegener WA. Veltuzumab (humanized anti-CD20 monoclonal antibody): characterization, current clinical results, and future prospects. Leuk Lymphoma. 2010 May;51(5):747-55. doi: 10.3109/10428191003672123. | |
| 19451441 | Result | Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon MO, Coleman M, Schuster SJ, Dyer MJ, Horne H, Teoh N, Wegener WA, Goldenberg DM. Humanized anti-CD20 antibody, veltuzumab, in refractory/recurrent non-Hodgkin's lymphoma: phase I/II results. J Clin Oncol. 2009 Jul 10;27(20):3346-53. doi: 10.1200/JCO.2008.19.9117. Epub 2009 May 18. |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C493846 | veltuzumab |
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|
| over 12 weeks |
| Efficacy | 4, 8 and 12 wks, every 3 months |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |