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This study is being done to assess the safety and tolerance of different doses of humanized hA20 in patients with NHL.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| veltuzumab | Drug | once weekly intravenous dosing for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of hA20 with this administration schedule and dosing | first 12 weeks, then over 2 years | |
| tolerance of hA20 with this administration schedule and dosing | first 12 weeks | |
| immunogenicity of hA20 with this administration schedule and dosing | first 12 weeks, as needed over 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics of hA20 | first 12 weeks, then up to 2 years | |
| pharmacokinetics hA20 | first 12 weeks, then up to 2 years | |
| assess efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Wegener, MD, PhD | Gilead Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service Des Maladies Du Sang | Lille | Cedex | 59037 | France | ||
| Centre hospitalier Lyon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15102696 | Background | Stein R, Qu Z, Chen S, Rosario A, Shi V, Hayes M, Horak ID, Hansen HJ, Goldenberg DM. Characterization of a new humanized anti-CD20 monoclonal antibody, IMMU-106, and Its use in combination with the humanized anti-CD22 antibody, epratuzumab, for the therapy of non-Hodgkin's lymphoma. Clin Cancer Res. 2004 Apr 15;10(8):2868-78. doi: 10.1158/1078-0432.ccr-03-0493. | |
| 16778139 |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008224 | Lymphoma, Follicular |
| D016393 | Lymphoma, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C493846 | veltuzumab |
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| 4 and 12 weeks, then every 3 months for 2 years |
| Lyon |
| Pierre Benite Cedex |
| 69495 |
| France |
| University of Leicester | Leicester | LE1 9HN | United Kingdom |
| Stein R, Qu Z, Chen S, Solis D, Hansen HJ, Goldenberg DM. Characterization of a humanized IgG4 anti-HLA-DR monoclonal antibody that lacks effector cell functions but retains direct antilymphoma activity and increases the potency of rituximab. Blood. 2006 Oct 15;108(8):2736-44. doi: 10.1182/blood-2006-04-017921. Epub 2006 Jun 15. |
| 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. |
| Result | Franck Morschhauser1*, John P Leonard2, Bertrand Coiffier3*, et.al. INITIAL SAFETY AND EFFICACY RESULTS OF A SECOND-GENERATION HUMANIZED ANTI-CD20 ANTIBODY, IMMU-106 (HA20), IN NON-HODGKINS LYMPHOMA: ASH abstract 2005. |
| Result | Morschhauser F, Leonard JP, Coiffier B Petillon M, Coleman M,. Bahkti A, Teoh N, Wegener WA, Goldenberg DM. Phase I/II result of a seoncd-generation humanized anti- CD20 antibody, IMMU-106 (.hA20), in NHL: 2006 ASCO Annual Meeting.Proceedings; 24/18S Part I of II:429s |
| Result | Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon M, Coleman M,. Horne H, Teoh N, Wegener WA, Goldenberg DM. Low doses of humanized anti-CD20 antibody, IMMU-106 (hA20), in refractory or recurrent NHL: Phase I/II results. 2007 ASCO Annual Meeting.Proceedings; 25/18S Part I of II:449s |
| 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. |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |