Spots Global Cancer Trial Database for Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)
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Trial Identification
Brief Title: Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)
Official Title: A Phase 3, Multicenter, Randomized, Openlabel, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) Versus Chlorambucil as First-Line Therapy for Previously Untreated Elderly Patients With B-Cell Chronic Lymphocytic Leukemia (The Origin Trial)
Study ID: NCT00910910
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.
Detailed Description: After notification from the US Food and Drug Administration (FDA) on 12 July 2013, Celgene agreed to discontinue the lenalidomide treatment for all patients due to an imbalance in the number of deaths in patients treated with lenalidomide versus patients treated with chlorambucil. No specific causality for this imbalance has been identified to date. Investigators were instructed to immediately discontinue all participants from experimental lenalidomide treatment and inform their patients accordingly. Participants on the Chlorambucil arm may continue up to 12 months (13 cycles) with the last participant completing in March 2014. All randomized participants will continue to be followed for overall survival and secondary primary malignancies.
Keywords
Eligibility
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
California Cancer Associates for Research and Excellence cCARE, Escondido, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Cancer Center of Central Connecticut, Southington, Connecticut, United States
University Hematology Oncology Inc., Centralia, Illinois, United States
North Chicago VA Medical Center, North Chicago, Illinois, United States
Medical Consultants, PC, Muncie, Indiana, United States
Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services, New Albany, Indiana, United States
Purchase Cancer Group, Paducah, Kentucky, United States
University of Minnesota, Minneapolis, Minnesota, United States
Saint Louis University Cancer Center, Saint Louis, Missouri, United States
Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Oncology and Hematology Associates, PA, Denville, New Jersey, United States
The Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey, United States
Somerset Hematology-Oncology Associates, Somerville, New Jersey, United States
Roswell Park Cancer Center, Buffalo, New York, United States
New York Medical College, Valhalla, New York, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Drexel University, College of Medicine, Philadelphia, Pennsylvania, United States
Pottstown Memorial Medical Center, Pottstown, Pennsylvania, United States
Berks Hematology-Oncology Associates, West Reading, Pennsylvania, United States
Geisinger Health System, Wilkes-Barre, Pennsylvania, United States
Charleston Hematology Oncology P.A., Charleston, South Carolina, United States
South Carolina Cancer Specialists, Hilton Head Island, South Carolina, United States
Central Texas Veterans Health Care System, Temple, Texas, United States
Swedish Tumor Institute, Seattle, Washington, United States
Providence St. Mary Regional Cancer Center, Walla Walla, Washington, United States
Columbia St Marys Cancer Center, Milwaukee, Wisconsin, United States
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
IMVS, Adelaide, South Australia, Australia
Western Hospital, Footscray, Victoria, Australia
Royal Melbourne Hospital, Melbourne, Victoria, Australia
Flinders Medical Centre, Bedford Park, , Australia
St. Vincent Hospital, Fitzroy, , Australia
Nepean Hospital, Kingswood, NSW, , Australia
Calvary Mater Hospital, Waratah, , Australia
Westmead Hospital Australia, Westmead, , Australia
Universitaetsklinik Innsbruck, Innsbruck, , Austria
Medical University of Vienna Internalmedicine 1, Hematology, Vienna, , Austria
Institut Jules Bordet, Brussels, , Belgium
Hopital Erasme, Brussels, , Belgium
Hopital de Jolimont, Haine-Saint Paul, , Belgium
AZ Groeninge, Kortrijk, , Belgium
UZ Leuven, Leuven, , Belgium
CHU Mont -Godinne, Yvoir, , Belgium
Monte Tabor - Hospital Sao Rafael, Salvador, Bahia, Brazil
BIOCANCER - Centro de Pesquisa e Tratamento do Câncer S/A, Belo Horizonte, Minas Gerais, Brazil
Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, Rio Grande Do Sul, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos, São Paulo, Brazil
Hospital Universitario de Brasilia, Brasílía, , Brazil
Hospital Erasto Gaertner, Curitiba, , Brazil
Pro Onco Centro de Tratamento Oncologico, Londrina, , Brazil
Hospital Israelita Albert Einstein, Morumbi, , Brazil
Instituto Estadual Arthur de Siqueira Cavalcanti - HEMORIO, Rio de Janeiro, , Brazil
Instituto Nacional de Cancer - INCA, Rio de Janeiro, , Brazil
Centro de Estudos e Pesquisas de Hematologia e Oncologia da Faculdade de Medicina do ABC, Santo Andre, , Brazil
Instituto de Ensino e Pesquisa Sao Lucas, São Paulo, , Brazil
Fundação Antonio Prudente - AC Camargo Câncer center, São Paulo, , Brazil
MHAT Georgi Stranski PlevenHematology Clinic, Pleven, , Bulgaria
University hospital Sveti Georgi Hematology Clinic, Plovdiv, , Bulgaria
Military Medical Academy, Sofia, , Bulgaria
National Specialized Hospital for Active Treatment of Hematology Diseases, Sofia, , Bulgaria
University hospital Sveta Marina, Varna, , Bulgaria
Regional Health Authority B-Saint John Regional Hospital, Saint John, New Brunswick, Canada
General Hospital, Eastern Health, St John's, Newfoundland and Labrador, Canada
Hospital Charles LeMoyne, Greenfield Park, Quebec, Canada
Sacre-Couer Hospital, Montreal, Quebec, Canada
Instituto Oncologico, Renaca, , Chile
Instituto Clinico Oncologico del Sur ICOS, Temuco, , Chile
Oncomedica S.A., Monteria, , Colombia
University Hospital Centre Split, Split, , Croatia
General Hospital Sveti Duh, Zagreb, , Croatia
Klinicka bolnica Dubrava Klinika za unutarnje bolesti Odjel za Hematologiju, Zagreb, , Croatia
University Hospital Centre Zagreb, Zagreb, , Croatia
University Hospital2.Dep.Intern.Med. Hematology, Hradec Kralove, , Czechia
Fakultni nemocnice Ostrava, Ostrava, , Czechia
Faculty Hospital Kralovske Vinohrady, Prague, , Czechia
Rigshospitalet University Hospital, Copenhagen, , Denmark
Herlev University Hospital Dep of hematology, Harlev, , Denmark
Roskilde University Hospital, Roskilde, , Denmark
Bergonie Institut, Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
CHRU, Grenoble cedex 09, , France
CHU Dupuytren, Limoges, , France
Hopital de l'Archet 1, Nice, , France
CHU Hautepierre, Strasbourg, , France
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Debrecen, , Hungary
Kaposi Mor Oktato Korhaz, Kaposvar, , Hungary
Szegedi TudomanyegyetemII Belgyogyaszati Klinika, Szeged, , Hungary
Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza, Tatabanya, , Hungary
Petz Aladar Country Hospital, Vasvari Pal U. 2, , Hungary
Ha'Emek Medical Center, Afula, , Israel
Barzilai Medical Center, Ashkelon, , Israel
Soroka University Medical Center, Beer Sheva, , Israel
Bnei Zion Medical Center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Meir Medical Center, Kfar-Saba, , Israel
Western Galilee Hospital, Naharia, , Israel
Rabin Medical Center, Petach Tikva, , Israel
Kaplan Medical Center, Rehovot, , Israel
Tel Aviv Sourasky Medical Center Department of Hematology, Tel Aviv, , Israel
Sheba Medical Center, Tel Hashomer, , Israel
Azienda Ospedaliera Policlinico di Bari, Bari, , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan, , Italy
Ospedale San Raffaele S.r.l., Milan, , Italy
Istituto Europeo di Oncologia - IEO, Milan, , Italy
Azienda Ospedaliero Universitaria di Modena, Modena, , Italy
Ospedale Cardarelli, Naples, , Italy
Universita del Piemonte Orientale, Novara, , Italy
AOU San Luigi Gonzaga, Orbassano, , Italy
Universita degli Studi di Padova, Padova, , Italy
Ospedale S. Chiara, Pisa, , Italy
Azienda Ospedaliera Ospedale San Carlo, Potenza, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte, Siena, , Italy
Ospedale Umberto I, Torrette Di Ancona, , Italy
Maxima Medisch Centrum, Eindhoven, , Netherlands
Spaame Ziekenhuis, Hoofddorp, , Netherlands
Isala Klinieken, Zwolle, , Netherlands
Christchurch Hospital, Christchurch, , New Zealand
North Shore University Hospital, Takapuna, , New Zealand
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika, Lodz, , Poland
Specjalistyczny Szpital miejski im. Kopernika, Torun, , Poland
Klinika Chorob wewnetrznych i Hematologii, Warszawa, , Poland
Nowotworww Krwi i Transplantacji Szpiku, Wroclaw, , Poland
Hospitais da Universidade de Coimbra, Coimbra, , Portugal
Instituto Portugues Oncologia do Porto Francisco Gentil EPE, Porto, , Portugal
Institutul Clinic Fundeni, Bucharest, , Romania
Spitalul Clinic Coltea, Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi, Iasi, , Romania
Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu, , Romania
Spitalul Clinic Municipal de Urgenta Timisoara, Timisoara, , Romania
Archangelsk Regional Clinical Hospital, Arkhangelsk, , Russian Federation
City Hospital 8, Barnaul, , Russian Federation
Regional Clinical Hospital 1, Ekaterinburg, , Russian Federation
Russian Academy of Medical Sciences Institution, Moscow, , Russian Federation
Moscow GUZ City Clinical Hospital, Moscow, , Russian Federation
NUZ Central Clinical Hospital, Moscow, , Russian Federation
GUZ Nizhegorodskaya Regional Clinical Hospital, Nizhniy Novgorod, , Russian Federation
MUZ City clinical hospital, Novosibirsk, , Russian Federation
St. Petersburg Research Institute of Hematology and Blood Transfusion, St. Petersburg, , Russian Federation
GUS Leningrad Regional Clinical Hospital, St. Petersburg, , Russian Federation
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov, St. Petersburg, , Russian Federation
Clinical Center Kragujevac, Kragujevac, , Serbia
Clinical Center Nis, Nis, , Serbia
Narodny onkologicky ustav, Bratislava, , Slovakia
Martinska Fakultna Nemocnica, Martin, , Slovakia
University Witwatersrand Oncology, Parktown, , South Africa
Pretoria Academic Hospital, Pretoria, , South Africa
Mary Potter Oncology Centre, Pretoria, , South Africa
Hospital Germans Trias I Pujol, Badalona, , Spain
Hospital Universitario Vall D hebron, Barcelona, , Spain
Hospital Universitario de la Princesa, Madrid, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Hospital Universitario Puerta de Hierro-Majadahonda, Majadahonda, , Spain
Hospital General Universitario Morales Messeguer, Murcia, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Donostia, San Sebastian, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Royal Bournemouth General Hospital, Bournemouth, , United Kingdom
St. Bartholomew's and The Royal London Hospital, London, , United Kingdom
St George's Healthcare NHS Trust, London, , United Kingdom
Contact Details
Name: Jeffrey Jones, MD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR
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