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| Sponsor: | Genmab |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Genmab |
| ClinicalTrials.gov Identifier: | NCT00349349 |
Purpose
The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.
| Condition | Intervention | Phase |
|---|---|---|
|
B-Cell Chronic Lymphocytic Leukemia |
Drug: ofatumumab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Single-Arm, International, Multi-Center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With B-Cell Chronic Lymphocytic Leukemia Who Have Failed Fludarabine and Alemtuzumab |
| Estimated Enrollment: | 225 |
| Study Start Date: | June 2006 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| Comprehensive Cancer Center | |
| Palm Springs, California, United States, 92262 | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093 | |
| United States, Colorado | |
| University of Colorado | |
| Aurora, Colorado, United States, 80010 | |
| United States, Iowa | |
| University of Iowa Hospital and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Louisiana | |
| Louisiana State University Health Science Center | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, New York | |
| Weill Medical College of Cornell University, Department of Medicine, Division of Hematology & Oncology | |
| New York, New York, United States, 10021 | |
| NYU Cancer Institute | |
| New York, New York, United States, 10016 | |
| University of Rochester Medical Center, James P. Wilmot Cancer Center | |
| Rochester, New York, United States, 14643 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Long Island Jewish Medical Center, Division of Hematology and Oncology | |
| New Hyde Park, New York, United States, 11040 | |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Texas | |
| UTMD Anderson Cancer Center, Dept. of Leukemia | |
| Houston, Texas, United States, 77230-1402 | |
| CTRC at The UT Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Cancer Research Specialists | |
| Salt Lake City, Utah, United States, 84106 | |
| Austria | |
| Allgemeines Krankenhaus | |
| Wien, Austria, 1090 | |
| Universitätsklinik Graz | |
| Graz, Austria, 8036 | |
| St. Johanns-Spital | |
| Salzburg, Austria, 5020 | |
| Universitätsklinik Innsbruck | |
| Innsbruck, Austria, 6020 | |
| Belgium | |
| St-Luc University Hospital | |
| Brussels, Belgium, 1000 | |
| Gasthuisberg UCH | |
| Leuven, Belgium, 3000 | |
| AZ Sint-Jan AV | |
| Brugge, Belgium, 800 | |
| UCL de Mont-Godinne | |
| Yvoir, Belgium, 5530 | |
| Institut Jules Bordet | |
| Brussels, Belgium | |
| Hopital de Jolimont | |
| Haine.St. Pierre, Belgium | |
| Czech Republic | |
| General Faculty Hospital, Internal Clinic Hematooncology | |
| Prague, Czech Republic | |
| Faculty Hospital Brno, Internal Hematooncology Clinic | |
| Brno, Czech Republic | |
| Faculty Hospital Hradec Kralove, Internal Hematooncology Clinic | |
| Hradec Kralove, Czech Republic | |
| Faculty Hospital Kralovske Vinohrady | |
| Prague, Czech Republic | |
| Denmark | |
| Rigshospitalet, Hæmatologisk Klinik | |
| Copenhagen, Denmark, 2100 | |
| Vejle Sygehus, Hæmatologisk Afdeling, | |
| Vejle, Denmark, 7100 | |
| France | |
| Centre Hospitalier Lyon -Sud, Service d'Hématologie | |
| Pierre-Bénite, France, 69495 | |
| Hopital Jean Bernard | |
| Poitiers, France | |
| Hôpital St-Louis | |
| Paris, France, 75475 | |
| Service Hematologie, Hopital Lapeyronie | |
| Montpellier, France | |
| Hôpitaux de Brabois | |
| Vandoeuvre les Nancy, France, 54500 | |
| Service d'Hematologie Clinique | |
| Nice, France | |
| Service D'Hématologie, Centre Henri Becquerel | |
| Rouen, France, 76038 | |
| Germany | |
| Universitätsklinikum Schleswig-Holstein | |
| Kiel, Germany, 24116 | |
| Universitätsklinikum des Saarlandes, | |
| Homburg, Germany, 66421 | |
| Universitätsklinikum Ulm | |
| Ulm, Germany, 89081 | |
| University Clinic Mainz, | |
| Mainz, Germany, 55131 | |
| University Clinic Dresden | |
| Dresden, Germany, 01307 | |
| Asklepios Klinik St Georg | |
| Hamburg, Germany, 20099 | |
| Hämatologisch-Onkologisches Institut für medizinische Studien und Serviceleistungen | |
| Mönchengladback-Rheydt, Germany, 41239 | |
| Universitätsklinikum Essen | |
| Essen, Germany, 45122 | |
| Charite, University Medicine Berlin, Campus Benjamin Franklin | |
| Berlin, Germany, 12200 | |
| University Clinic Erlangen, Medical Clinic III | |
| Erlangen, Germany, 91054 | |
| Klinikum rechts der Isar der TU München | |
| München, Germany | |
| Italy | |
| Universita La Sapienza, Divisione di Ematologia | |
| Roma, Italy | |
| Universita degli studi di Bari -Ospedale Policlinico - Dipartimento di Ematologia | |
| Bari, Italy | |
| Ospedale Niguarda Cà Granda, Dipartimento di Ematologia | |
| Milan, Italy | |
| Poland | |
| Klinika Hematologii UM w Lodzi | |
| Lodz, Poland | |
| Klinika Hematologii i Transplantacji | |
| Katowice, Poland | |
| Klinika Hematologii AM | |
| Gdansk, Poland | |
| Klinika Hematologii AM | |
| Bialystok, Poland | |
| Klinika Hematologii CMUJ | |
| Krakow, Poland | |
| Klinika Hematologii i Chorob Rozrostowych | |
| Poznan, Poland | |
| Spain | |
| Hospital Clinic i Provincial de Barcelona | |
| Barcelona, Spain | |
| Hospital de la Santa Creu i Sant Pau | |
| Barcelona, Spain | |
| Hospital Germans Trias i Pujol | |
| Barcelona, Spain | |
| Sweden | |
| Akademiska Sjukhuset | |
| Uppsala, Sweden, 751 85 | |
| University Hospital, Medical Clinic | |
| Örebro, Sweden, 701 85 | |
| Sweden, Solna | |
| Karolinka Universitetssjukhuset | |
| Stockholm, Solna, Sweden, 171 76 | |
| United Kingdom | |
| St James Institute of Oncology, St James University Hospital, | |
| Leeds, United Kingdom | |
| Nottingham City Hospital | |
| Nottingham, United Kingdom | |
| Addenbrooke's Hospital, Department of Haematology | |
| Cambridge, United Kingdom | |
| Royal Liverpool University Hospital | |
| Liverpool, United Kingdom | |
| John Radcliffe Hospital, Haematology Department | |
| Oxford, United Kingdom | |
| St Bartholomew's Hospital, The Cancer Centre | |
| London, United Kingdom | |
| Leicester Royal Infirmary, Oncology & Haematology Clinical Trials Unit | |
| Leicester, United Kingdom | |
| Study Chair: | Anders Österborg, Professor | Karolinska Hospital, Stockholm, Sweden |
| Study Chair: | William Wierda, Asst. Prof. | M.D. Anderson Cancer Center, Houston, Texas, US |
More Information
| Responsible Party: | Genmab A/S ( International Clinical Trial Manager ) |
| Study ID Numbers: | Hx-CD20-406 |
| Study First Received: | July 6, 2006 |
| Last Updated: | July 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00349349 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
B-CLL |
|
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Pharmacologic Actions Leukemia Lymphatic Diseases |
Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Alemtuzumab Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders |
