A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL).
NCT ID: NCT01021423
Last Updated: 2019-11-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
9 participants
INTERVENTIONAL
2010-04-01
2011-03-01
Brief Summary
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This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lenalidomide
Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Lenalidomide
15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Placebo
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Placebo
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Interventions
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Lenalidomide
15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Placebo
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* One of the following first-line induction chemotherapy regimens with rituximab: (1) combination regimen containing all of the following components: cyclophosphamide, vincristine, adriamycin and a glucocorticoid; (2) Fludarabine containing regimen such as FC (fludarabine, cyclophosphamide)
* Achieved a PR or better response after the first-line induction chemotherapy regimen (assessed by 2007 Revised Response Criteria for Malignant Lymphoma)
* ECOG performance status score of ≤ 2
* Willing to follow pregnancy precaution
Exclusion Criteria
* Patients who have received less than 4 cycles of R-CHOP, R-CHOP-like, or R-FC are ineligible;
* Patients who achieved stable disease or progressive disease as best response with first line-induction chemotherapy;
* Any of the following laboratory abnormalities:
* Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5\*10\^9/L)
* Platelet count \< 60,000/mm\^3 (60\*10\^9/L)
* Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT)) \> 3.0 times upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
* Serum bilirubin \> 1.5 times ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma
* Calculated creatinine clearance (i.e. Cockcroft-Gault formula) of \< 30 mL /min
* Active or any history of central nervous system (CNS) lymphoma or leptomeningeal involvement by lymphoma
* Subjects at high risk for deep vein thrombosis (DVT) not willing to take DVT prophylaxis
* Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Dreyling, Prof. Dr
Role: PRINCIPAL_INVESTIGATOR
Medizinische Klinik III der Universität München
Locations
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Sharp Healthcare Oncology Associates of San Diego
San Diego, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Providence Cancer Center
Indianapolis, Indiana, United States
Nebraska Hematology-Oncology, PC
Lincoln, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Arena Oncology Associates
Lake Success, New York, United States
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
University of Virginia Health Systems
Charlottesville, Virginia, United States
Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie
Hradec Králové, , Czechia
Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika
Olomouc, , Czechia
Fakultni Nemocnice Kralovske Vinohrady
Prague, , Czechia
Vseobecna Fakultni Nemocnice
Prague, , Czechia
Clinic of Oncology Faculty Hospital Motol
Prague, , Czechia
CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique
Amiens, , France
CHU Hôpital Hotel Dieu
Angers, , France
CHU ESTAING, Service d'Hématologie
Clermont-Ferrand, , France
Hôpital Henri Mondor Unité Hémopathies Lymphoides
Créteil, , France
CHD Les Oudairies, Service d'Oncologie Hématologie
La Roche-sur-Yon, , France
Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
La Tronche, , France
CHRU - Hôpital Claude Huriez
Lille, , France
CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale
Montpellier, , France
CHRU - Hotel Dieu
Nantes, , France
Hôpital Saint-Louis
Paris, , France
CHRU - Hôpital du Haut Lévêque, maladies du sang, Centre François Magendie
Pessac, , France
Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
Pierre-Bénite, , France
CHU de Poitiers, Pôle Régional de Cancérologie, Service d'Oncologie Hématologie et Thérapie Cellulaire
Poitiers, , France
CHU de Reims, Hôpital Robert Debré, Hématologie Clinique
Reims, , France
Hôpital Pontchaillou Hématologie Clinique
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Hôpital Purpan CHU de Toulouse
Toulouse, , France
Hôpital Bretonneau - CHU Tours
Tours, , France
CHU de Nancy Hôpital de Brabois, Service d'Hématologie et Médecine Interne
Vandœuvre-lès-Nancy, , France
Universitätsklinikum Essen Zentrum für Innere Medizin
Essen, , Germany
Universitätsklinikum Freiburg - Medizinische Klinik - Abteilung Innere Medizin I: Hämatologie und Onkologie
Freiburg im Breisgau, , Germany
UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie
Göttingen, , Germany
Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation
Hamburg, , Germany
Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe
Karlsruhe, , Germany
Klinikum der Universität München - Großhadern, Medizinische Klinik III
München, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Soroka Medical Center The Institute of Hematology
Beersheba, , Israel
Davidoff Cancer Center The Institute of Hematology
Petah Tikva, , Israel
Az. Osp. SS.Antonio e Biagio SC Ematologia
Alessandria, , Italy
Ospedale Regionale di Bolzano - Divisione di Ematologia
Bolzano, , Italy
Hematology Dept, Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Azienda Ospedaliera Universitaria "San Martino"
Genova, , Italy
Az. Osp. Ospedali Riuniti Papardo - Piemonte - S.C. Ematologia
Messina, , Italy
A,O Ospedale Niguarda Ca Granda Dept Hematology
Milan, , Italy
Fondazione San Raffaele del Monte Tabor I.R.C.C.S.
Milan, , Italy
Istituto Nazionale Tumori Fondazione "G. Pascale" - Oncoematologia
Napoli, , Italy
Università del Piemonte Orientale "Amedeo Avogadro"
Novara, , Italy
Policlinico San Matteo - Dip. Di Ematologia
Pavia, , Italy
Az. Osp. Bianchi Melacrino Morelli, Div. Di Ematologia
Reggio Calabria, , Italy
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
Roma, , Italy
IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia
S.Giovanni Rotondo (FG), , Italy
Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette)
Torino, , Italy
Ospedale Cardinale G. Panico - Ematologia e Immunoematologia
Tricase, , Italy
Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria
Udine, , Italy
Małopolskie Centrum Medyczne
Krakow, , Poland
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
Lodz, , Poland
Dolnoslaskie Centrum Transplantacji Komórkowych
Wroclaw, , Poland
Serviço de Hematologia
Coimbra, , Portugal
Instituto Português de Oncologia (IPO) de Lisboa
Lisbon, , Portugal
Instituto Português de Oncologia (IPO) do Porto
Porto, , Portugal
Centro de Cancer, Hospital Espanol Auxilio de Puerto Rico
San Juan, , Puerto Rico
Republican Clinical Oncological Dispensary
Kazan', , Russia
Russian Oncological Research Centre
Moscow, , Russia
Perm Regional Clinical Hospital
Perm, , Russia
Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-biological agency
Saint Petersburg, , Russia
State Educational Institution of High Professional Education
Saint Petersburg, , Russia
Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov Rosmedtechnologies
Saint Petersburg, , Russia
State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1
Volgograd, , Russia
Sverdlovsk Regional Clinical Hospital - Volgogradskaya
Yekaterinburg, , Russia
Hospital Universitario Vall d´Hebrón Hematology Department
Barcelona, , Spain
Hospital de Madrid Norte- Sanchinarro
Madrid, , Spain
Hospital Costa del Sol, Oncology
Marbella (Málaga), , Spain
C. H. de Orense
Ourense, , Spain
Clinica Universitaria de Navarra, Hematology
Pamplona, , Spain
Hospital Clínico Universitario de Salamanca
Salamanca, , Spain
Hospital Marques de Valdecilla
Santander, , Spain
Kent and Canterbury Hospital
Canterbury, Kent, , United Kingdom
Torbay Hospital
County of Devon, , United Kingdom
Royal Devon & Exeter Hospital
Exeter, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Barts & The London NHS Trust Medical Oncology
London, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Salisbury NHS Foundation Trust, Haematology
Salisbury, , United Kingdom
St Helens Hospital, Lilac Lower Ground
St Helens, , United Kingdom
Countries
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References
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Vose JM, Habermann TM, Czuczman MS, Zinzani PL, Reeder CB, Tuscano JM, Lossos IS, Li J, Pietronigro D, Witzig TE. Single-agent lenalidomide is active in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell transplantation. Br J Haematol. 2013 Sep;162(5):639-47. doi: 10.1111/bjh.12449. Epub 2013 Jul 9.
Other Identifiers
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CC-5013-MCL-003
Identifier Type: -
Identifier Source: org_study_id
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