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
NCT ID: NCT00737529
Last Updated: 2018-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
134 participants
INTERVENTIONAL
2008-12-22
2017-11-08
Brief Summary
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Detailed Description
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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for second primary malignancies and OS will continue until 100% of the patients have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the last patient enrolled, whichever comes first.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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lenalidomide
Single agent Lenalidomide
Lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but \< 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
lenalidomide
25mg oral capsules continuous days 1-21 each of a 28 day cycle
Interventions
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lenalidomide
25mg oral capsules continuous days 1-21 each of a 28 day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have documents relapsed, refractory or PD after treatment with bortezomib
* Must have measureable disease on cross sectional imaging by CT
* Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2
* Willing to follow pregnancy precautions
Exclusion Criteria
* Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5 x 109/L)
* Platelet count \< 60,000/mm3 (60 x 109/L)
* Serum aspartate transaminase/Serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) \> 3.0 x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma.
* Serum total bilirubin \> 1.5 x ULN, except in cases of Gilbert's Syndrome and documented liver involvement by lymphoma.
* Calculated creatinine clearance (Cockcroft-Gault formula) of \< 30 mL /min
* Patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible
* History of active central nervous system (CNS) lymphoma within the previous 3 months
* Subjects not willing or unable to take deep vein thrombosis (DVT) prophylaxis
* Prior history of malignancies, other than MCL, unless the patient has been free of the disease for ≥ 3 years
* Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Lei Zhang, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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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
St 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
Bruges, , Belgium
UZ Gent
Ghent, , Belgium
Universitair Ziekenhuis Leuven, Campus Gasthuisberg
Leuven, , Belgium
Hospital Universitario San Ignacio
Bogotá, , 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, , France
Institut de Cancerologie de la Loire
Saint Jean Priest En Jarez, , France
Hopital Hautepierre
Strasbourg, , France
University Hospital Wuerzburg
Würzburg, , 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
Győr, , Hungary
Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Rambam Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petch Tikva, , Israel
Sheba Medical Center
Tel Litwinsky, , 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 (Türkiye)
Istanbul Universitesi Istanbul
Istanbul, , Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi
Sihhiye Ankara, , Turkey (Türkiye)
Royal Cornwall Hospitals Trust
Truro, , United Kingdom
Countries
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References
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Goy A, Sinha R, Williams ME, Kalayoglu Besisik S, Drach J, Ramchandren R, Zhang L, Cicero S, Fu T, Witzig TE. Single-agent lenalidomide in patients with mantle-cell lymphoma who relapsed or progressed after or were refractory to bortezomib: phase II MCL-001 (EMERGE) study. J Clin Oncol. 2013 Oct 10;31(29):3688-95. doi: 10.1200/JCO.2013.49.2835. Epub 2013 Sep 3.
Goy A, Kalayoglu Besisik S, Drach J, Ramchandren R, Robertson MJ, Avivi I, Rowe JM, Herbrecht R, Van Hoof A, Zhang L, Cicero S, Fu T, Witzig T. Longer-term follow-up and outcome by tumour cell proliferation rate (Ki-67) in patients with relapsed/refractory mantle cell lymphoma treated with lenalidomide on MCL-001(EMERGE) pivotal trial. Br J Haematol. 2015 Aug;170(4):496-503. doi: 10.1111/bjh.13456. Epub 2015 Apr 28.
Witzig TE, Luigi Zinzani P, Habermann TM, Tuscano JM, Drach J, Ramchandren R, Kalayoglu Besisik S, Takeshita K, Casadebaig Bravo ML, Zhang L, Fu T, Goy A. Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma. Am J Hematol. 2017 Oct;92(10):E575-E583. doi: 10.1002/ajh.24854. Epub 2017 Aug 28.
San-Miguel JF, Richardson PG, Gunther A, Sezer O, Siegel D, Blade J, LeBlanc R, Sutherland H, Sopala M, Mishra KK, Mu S, Bourquelot PM, Victoria Mateos M, Anderson KC. Phase Ib study of panobinostat and bortezomib in relapsed or relapsed and refractory multiple myeloma. J Clin Oncol. 2013 Oct 10;31(29):3696-703. doi: 10.1200/JCO.2012.46.7068. Epub 2013 Sep 9.
Other Identifiers
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CC-5013-MCL-001
Identifier Type: -
Identifier Source: org_study_id