A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non- Hodgkin's Lymphoma
Sponsor study identifier
interventional
39
2 countries
3
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2007
Actual (reported)Study Completion
November 2007
Actual (reported)This study is being done to assess the safety and tolerance of different doses of humanized hA20 in patients with NHL.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
November 2007
Actual (reported)November 2007
Actual (reported)January 8, 2008
Actual (reported)January 17, 2008
Actual (reported)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
Pharmacodynamics of hA20
once weekly intravenous dosing for 4 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Service Des Maladies Du Sang
Lille, Cedex, 59037, France
Centre hospitalier Lyon
Lyon, Pierre Benite Cedex, 69495, France
University of Leicester
Leicester, LE1 9HN, United Kingdom
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.
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.
William Wegener, MD, PhD
Gilead Sciences
39 participants (actual enrollment reported by the registry).
First Submitted
January 8, 2008
First Posted
January 17, 2008
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
Safety Study of NHL With 90Y-hLL2 IgG
first 12 weeks, then up to 2 years
pharmacokinetics hA20
first 12 weeks, then up to 2 years
assess efficacy
4 and 12 weeks, then every 3 months for 2 years
Contact the study team to confirm eligibility.
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.
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.
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
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
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.
Primary Completion
November 2007
Actual (reported)Study Completion
November 2007
Actual (reported)Last Updated
August 18, 2021
Record last verified: 2012-02
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Source: ClinicalTrials.gov.
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