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).
- Conditions
- Mantle Cell LymphomaNon-Hodgkin's Lymphoma
- Interventions
- Other: Placebo
- Registration Number
- NCT01021423
- Lead Sponsor
- Celgene
- Brief Summary
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) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR).
This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant.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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- Histologically-proven mantle cell non-Hodgkin's lymphoma,
- 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
- Patients who have received more than 1 line of induction chemotherapy;
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. Lenalidomide 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.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) up to 7 years PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir.
Study terminated prematurely. Analysis not conducted.
- Secondary Outcome Measures
Name Time Method Overall Survival up to 7 years Overall survival was defined as the time from randomization to death from any cause.
Study terminated prematurely. Analysis not conducted.Participants With Treatment Emergent Adverse Events (TEAEs) up to 9 months Participants with treatment-emergent adverse events (TEAEs) during the treatment period plus 30 days. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.
The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE.Time to Progression up to 7 years Time to progression was defined as the time from the date of randomization until the first date of documented disease progression.
Study terminated prematurely. Analysis not conducted.Time to Treatment Failure up to 2 years Time to treatment failure was defined as the time from randomization until the date at which a participant was removed from treatment due to progression, toxicity, refusal or death or received another Non-Hodgkin Lymphoma (NHL) therapy, whichever occurs first.
Participants With a Tumor Response up to 7 years Number of participants with a measurable tumor at time of randomization who achieve a response. Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Partial response (PR) is defined as the regression of measurable disease and no appearance of new sites of disease. For full definitions, please refer to the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Study terminated prematurely. Analysis not conducted.
Related Research Topics
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Trial Locations
- Locations (91)
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-biological agency
🇷🇺St. Petersburg, Russian Federation
Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov Rosmedtechnologies
🇷🇺St. Petersburg, Russian Federation
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Nebraska Hematology-Oncology, PC
🇺🇸Lincoln, Nebraska, United States
Dolnoslaskie Centrum Transplantacji Komórkowych
🇵🇱Wroclaw, Poland
State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1
🇷🇺Volgograd, Russian Federation
Instituto Português de Oncologia (IPO) do Porto
🇵🇹Porto, Portugal
Republican Clinical Oncological Dispensary
🇷🇺Kazan, Russian Federation
CHRU - Hôpital Claude Huriez
🇫🇷Lille Cedex, France
CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale
🇫🇷Montpellier cedex 5, France
CHRU - Hotel Dieu
🇫🇷Nantes Cedex 1, France
Hôpital Saint-Louis
🇫🇷Paris Cedex 10, France
Universitätsklinikum Essen Zentrum für Innere Medizin
🇩🇪Essen, Germany
CHU de Reims, Hôpital Robert Debré, Hématologie Clinique
🇫🇷Reims Cedex, France
Centre Henri Becquerel
🇫🇷Rouen Cedex 1, France
Hôpital Pontchaillou Hématologie Clinique
🇫🇷Rennes Cedex, France
Hôpital Purpan CHU de Toulouse
🇫🇷Toulouse cedex 9, France
Hôpital Bretonneau - CHU Tours
🇫🇷Tours, France
CHU de Nancy Hôpital de Brabois, Service d'Hématologie et Médecine Interne
🇫🇷Vandoeuvre Les Nancy, France
Universitätsklinikum Freiburg - Medizinische Klinik - Abteilung Innere Medizin I: Hämatologie und Onkologie
🇩🇪Freiburg, Germany
UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie
🇩🇪Göttingen, Germany
Klinikum der Universität München - Großhadern, Medizinische Klinik III
🇩🇪München, Germany
Soroka Medical Center The Institute of Hematology
🇮🇱Beer Sheva, Israel
Davidoff Cancer Center The Institute of Hematology
🇮🇱Petah Tiqwa, Israel
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Az. Osp. SS.Antonio e Biagio SC Ematologia
🇮🇹Alessandria, Italy
Ospedale Regionale di Bolzano - Divisione di Ematologia
🇮🇹Bolzano, Italy
Azienda Ospedaliera Universitaria "San Martino"
🇮🇹Genova, Italy
Az. Osp. Ospedali Riuniti Papardo - Piemonte - S.C. Ematologia
🇮🇹Messina, Italy
Fondazione San Raffaele del Monte Tabor I.R.C.C.S.
🇮🇹Milano, Italy
Policlinico San Matteo - Dip. Di Ematologia
🇮🇹Pavia, Italy
Az. Osp. Bianchi Melacrino Morelli, Div. Di Ematologia
🇮🇹Reggio Calabria, Italy
Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette)
🇮🇹Torino, Italy
Ospedale Cardinale G. Panico - Ematologia e Immunoematologia
🇮🇹Tricase, Italy
Małopolskie Centrum Medyczne
🇵🇱Krakow, Poland
Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria
🇮🇹Udine, Italy
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
🇵🇱Lodz, Poland
Serviço de Hematologia
🇵🇹Coimbra, Portugal
Instituto Português de Oncologia (IPO) de Lisboa
🇵🇹Lisboa, Portugal
Centro de Cancer, Hospital Espanol Auxilio de Puerto Rico
🇵🇷San Juan, Puerto Rico
Russian Oncological Research Centre
🇷🇺Moscow, Russian Federation
Hospital Universitario Vall d´Hebrón Hematology Department
🇪🇸Barcelona, Spain
Perm Regional Clinical Hospital
🇷🇺Perm, Russian Federation
Hospital de Madrid Norte- Sanchinarro
🇪🇸Madrid, Spain
Hospital Costa del Sol, Oncology
🇪🇸Marbella (Málaga), Spain
Clinica Universitaria de Navarra, Hematology
🇪🇸Pamplona, Spain
Royal Devon & Exeter Hospital
🇬🇧Exeter, United Kingdom
Torbay Hospital
🇬🇧County Of Devon, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Barts & The London NHS Trust Medical Oncology
🇬🇧London, United Kingdom
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie
🇨🇿Hradec Králové, Czechia
Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika
🇨🇿Olomouc, Czechia
Weill Cornell Medical College/New York Presbyterian Hospital
🇺🇸New York, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
St Helens Hospital, Lilac Lower Ground
🇬🇧St. Helens, United Kingdom
Fakultni Nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
CHU ESTAING, Service d'Hématologie
🇫🇷Clermont Ferrand Cedex 1, France
University of Virginia Health Systems
🇺🇸Charlottesville, Virginia, United States
Vseobecna Fakultni Nemocnice
🇨🇿Praha 2, Czechia
CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique
🇫🇷Amiens Cedex, France
CHU Hôpital Hotel Dieu
🇫🇷Angers, France
CHD Les Oudairies, Service d'Oncologie Hématologie
🇫🇷La Roche sur Yon, France
Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
🇫🇷Pierre Bénite Cedex, France
Clinic of Oncology Faculty Hospital Motol
🇨🇿Prague 5, Czechia
CHRU - Hôpital du Haut Lévêque, maladies du sang, Centre François Magendie
🇫🇷Pessac, France
Hematology Dept, Azienda Ospedaliero Universitaria Careggi
🇮🇹Florence, Italy
A,O Ospedale Niguarda Ca Granda Dept Hematology
🇮🇹Milan, Italy
Istituto Nazionale Tumori Fondazione "G. Pascale" - Oncoematologia
🇮🇹Napoli, Italy
Università del Piemonte Orientale "Amedeo Avogadro"
🇮🇹Novara, Italy
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Sharp Healthcare Oncology Associates of San Diego
🇺🇸San Diego, California, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
Providence Cancer Center
🇺🇸Indianapolis, Indiana, United States
Arena Oncology Associates
🇺🇸Lake Success, New York, United States
Hôpital Henri Mondor Unité Hémopathies Lymphoides
🇫🇷Créteil, France
CHU de Poitiers, Pôle Régional de Cancérologie, Service d'Oncologie Hématologie et Thérapie Cellulaire
🇫🇷Poitiers, France
Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe
🇩🇪Karlsruhe, Germany
Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation
🇩🇪Hamburg, Germany
IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia
🇮🇹S.Giovanni Rotondo (FG), Italy
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
🇮🇹Roma, Italy
Sverdlovsk Regional Clinical Hospital - Volgogradskaya
🇷🇺Ekaterinburg, Russian Federation
State Educational Institution of High Professional Education
🇷🇺St. Petersburg, Russian Federation
C. H. de Orense
🇪🇸Ourense, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Marques de Valdecilla
🇪🇸Santander, Spain
Kent and Canterbury Hospital
🇬🇧Canterbury, Kent, United Kingdom
Salisbury NHS Foundation Trust, Haematology
🇬🇧Salisbury, United Kingdom