Spots Global Cancer Trial Database for A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial
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Trial Identification
Brief Title: A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial
Official Title: A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortezomib
Study ID: NCT00737529
Conditions
Interventions
Study Description
Brief Summary: To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.
Detailed Description: Follow up phase will continue until either 100% of the patients have died, are lost to follow up or have withdrawn consent or a maximum of 4 years from the last patient enrolled, whichever comes first. All other efficacy and safety endpoints will be updated at this time. In the unlikely event that the study will be closed and patients are still responding to treatment at this time, Celgene will discuss with the treating physicians options to provide further treatment to the patient after study closure in line with local regulation. Follow up for second primary malignancies and OS will continue until 100% of the patients have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the last patient enrolled, whichever comes first. 10 October 2017: In regard to the last subject last visit date/study completion date, the prolongation of timelines is due to the bridging of a treatment gap for a patient responding to study medication until non-study medication is available.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
UCSD Moores Cancer Center, La Jolla, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Tower Cancer Research Foundation, Los Angeles, California, United States
Boca Raton Community Hospital, Inc., Research Dept., Boca Raton, Florida, United States
Pasco Hernando Oncology Associates, PA, Brooksville, Florida, United States
Broward General Medical Center, Fort Lauderdale, Florida, United States
MD Anderson Cancer Center, Orlando Regional Healthcare, Orlando, Florida, United States
Lake County Oncology and Hematology, The Villages, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Loyola University Medical Center - Smith, Maywood, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Alvin and Lois Lapidus Cancer Institute Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
University of Massachusetts Medical Center, Worcester, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University Siteman Cancer Center, Saint Louis, Missouri, United States
University of Nebraska, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
NYU School of Medicine, New York, New York, United States
University of Rochester Cancer Center, James P. Wilmot Cancer Center, Rochester, New York, United States
Presbyterian Hospital, Charlotte, North Carolina, United States
Temple University School of Medicine, Philadelphia, Pennsylvania, United States
Hillman Cancer Institute at UPMC, Pittsburgh, Pennsylvania, United States
South Carolina Cancer Specialists, Hilton Head Island, South Carolina, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
University of Tennessee Cancer Institute, Memphis, Tennessee, United States
University of Virginia Cancer Center Clinical Trials Office, Charlottesville, Virginia, United States
Universitaetsklinik Innsbruck, Innsbruck, , Austria
Landeskrankenhaus Salzburg, Salzburg, , Austria
Medical University of Vienna, Vienna, , Austria
AZ Sint-Jan AV Brugge, Brugge, , Belgium
UZ Gent, Gent, , Belgium
Universitair Ziekenhuis Leuven, Campus Gasthuisberg, Leuven, , Belgium
Hospital Universitario San Ignacio, Bogota, , Colombia
Oncologos del occidente S.A., Pereira, , Colombia
Hopital Sud, CHU d'Amiens, Amiens, , France
Institut Bergonie, Bordeaux, , France
Hopital Henri Mondor, Créteil, , France
Hopital Emile Muller, Mulhouse, , France
Hopital Cochin, Paris, , France
Institut Curie, Paris, , France
Hopital Robert Debre, Reims Cedex, , France
Institut de Cancerologie de la Loire, Saint Jean Priest En Jarez, , France
Hopital Hautepierre, Strasbourg, , France
University Hospital Wuerzburg, Wuerzburg, , Germany
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Debrecen, , Hungary
University of Debrecen, DEOEC, Institute of Internal Medicine, Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat, Gyor, , Hungary
Kaposi Mor Oktato Korhaz, Kaposvar, , Hungary
Rambam Medical Center, Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Rabin Medical Center, Petch Tikva, , Israel
Sheba Medical Center, Tel Hashomer, , Israel
Universita Federico II di Napoli Nuovo Policlinico, Napoli, , Italy
Ospedale Civile dello Spirito Santo, Pescara, , Italy
Universita Cattololica del Sacro Cuore, Roma, , Italy
Centro De Cancer, Hospital Espanol Auxilio De Puerto Rico, San Juan, , Puerto Rico
Singapore General Hospital, Singapore, , Singapore
Hospital General De Elche, Alicante, , Spain
Duran i Reynals Institut Catala d'Oncologia, L'Hospitalet de Llobregat, , Spain
Hospital Clinico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Gazi Universitesi, Besevler Ankara, , Turkey
Istanbul Universitesi Istanbul, Istanbul, , Turkey
Ankara Universitesi Tip Fakultesi, Sihhiye Ankara, , Turkey
Royal Cornwall Hospitals Trust, Truro, , United Kingdom
Contact Details
Name: Lei Zhang, MD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR
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