A Phase I/II Study of Immunotherapy With Humanized Anti-CD20 Antibody, IMMU-106 (hA20), in Adult Patients With Chronic Immune Thrombocytopenic Purpura
Sponsor study identifier
interventional
48
1 country
8
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2011
Actual (reported)Study Completion
November 2011
Actual (reported)This trial will study different dose levels of hA20 (IMMU-106) to see if they are safe and effective for treating ITP.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2011
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.
October 17, 2007
Actual (reported)October 19, 2007
Actual (reported)November 2007
Date type not reportedThis date has not been verified as actual or estimated.
November 2011
Actual (reported)November 2011
Actual (reported)Primary - Safety
Hematology laboratory results and adverse events will be followed closely for one year.
1 year
Secondary - Efficacy
Platelet responses will be followed for up to 5 years.
5 years
veltuzumab is a humanized CD20 antibody administered subcutaneously.
hA20 will be administered intravenously in two doses over two weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Southern California- Keck School of Medicine
Los Angeles, California, 90033, United States
Center of Hope for Cancer and Blood Disorders
Riverdale, Georgia, 30274, United States
Georgia Cancer Specialtists
Tucker, Georgia, 30084, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Hematology Oncology Specialists
Metairie, Louisiana, 70006, United States
Denville, New Jersey, 07834, United States
Hematology/Oncology Specialists
Buffalo, New York, 14215, United States
Liebman HA, Saleh MN, Bussel JB, Negrea OG, Horne H, Wegener WA, Goldenberg DM. Comparison of two dosing schedules for subcutaneous injections of low-dose anti-CD20 veltuzumab in relapsed immune thrombocytopenia. Haematologica. 2016 Nov;101(11):1327-1332. doi: 10.3324/haematol.2016.146738. Epub 2016 Aug 11.
Liebman HA, Saleh MN, Bussel JB, Negrea OG, Horne H, Wegener WA, Goldenberg DM. Low-dose anti-CD20 veltuzumab given intravenously or subcutaneously is active in relapsed immune thrombocytopenia: a phase I study. Br J Haematol. 2013 Sep;162(5):693-701. doi: 10.1111/bjh.12448. Epub 2013 Jul 6.
William Wegener, MD, PHD
Gilead Sciences
48 participants (actual enrollment reported by the registry).
First Submitted
October 17, 2007
First Posted
October 19, 2007
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL
Contact the study team to confirm eligibility.
New York Presbyterian Hospital Weill Cornell Medical Center
New York, New York, 10021, United States
Primary Completion
November 2011
Actual (reported)Study Completion
November 2011
Actual (reported)Last Updated
August 16, 2021
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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