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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). (RENEW)

This study has been terminated.
(Terminated by sponsor due to new unpublished data that rendered the current design of the study no longer clinically relevant. There were no safety concerns.)
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01021423
First received: November 25, 2009
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

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This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant.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.


Condition Intervention Phase
Mantle Cell Lymphoma
Non-Hodgkin's Lymphoma
Drug: Lenalidomide
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]

    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:
  • Overall Survival [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]

    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) [ Time Frame: up to 9 months ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]

    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 [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]

    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.



Enrollment: 9
Study Start Date: April 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: Revlimid
Experimental: 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: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021423

  Hide Study Locations
Locations
United States, California
Sharp Healthcare Oncology Associates of San Diego
San Diego, California, United States, 92123
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Providence Cancer Center
Indianapolis, Indiana, United States, 97213
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Nebraska
Nebraska Hematology-Oncology, PC
Lincoln, Nebraska, United States, 68506
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Arena Oncology Associates
Lake Success, New York, United States, 11042
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, United States, 10021
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Virginia
University of Virginia Health Systems
Charlotteville, Virginia, United States, 22908
Czech Republic
Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie
Hradec Králové, Czech Republic, 500 05
Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika
Olomouc, Czech Republic, 77520
Clinic of Oncology Faculty Hospital Motol
Prague 5, Czech Republic
Fakultni Nemocnice Kralovske Vinohrady
Praha 10, Czech Republic, 10034
Vseobecna Fakultni Nemocnice
Praha 2, Czech Republic, 12808
France
CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique
Amiens Cedex, France, 80054
CHU Hôpital Hotel Dieu
Angers, France, 49000
CHU ESTAING, Service d'Hématologie
Clermont Ferrand Cedex 1, France, 63003
Hôpital Henri Mondor Unité Hémopathies Lymphoides
Créteil, France, 94010
CHD Les Oudairies, Service d'Oncologie Hématologie
La Roche sur Yon, France, 85000
Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
La Tronche, France, 38700
CHRU - Hôpital Claude Huriez
Lille Cedex, France, 59037
CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale
Montpellier cedex 5, France, 34295
CHRU - Hotel Dieu
Nantes Cedex 1, France, 44093
Hôpital Saint-Louis
Paris Cedex 10, France, 75475
CHRU - Hôpital du Haut Lévêque, maladies du sang, Centre François Magendie
Pessac, France, 33604
Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie
Pierre Bénite Cedex, France, 69495
CHU de Poitiers, Pôle Régional de Cancérologie, Service d'Oncologie Hématologie et Thérapie Cellulaire
Poitiers, France, 86000
CHU de Reims, Hôpital Robert Debré, Hématologie Clinique
Reims Cedex, France, 51092
Hôpital Pontchaillou Hématologie Clinique
Rennes Cedex, France, 35033
Centre Henri Becquerel
Rouen Cedex 1, France, 76038
Hôpital Purpan CHU de Toulouse
Toulouse cedex 9, France, 31059
Hôpital Bretonneau - CHU Tours
Tours, France, 37044
CHU de Nancy Hôpital de Brabois, Service d'Hématologie et Médecine Interne
Vandoeuvre Les Nancy, France, 54511
Germany
Universitätsklinikum Essen Zentrum für Innere Medizin
Essen, Germany, 45122
Universitätsklinikum Freiburg - Medizinische Klinik - Abteilung Innere Medizin I: Hämatologie und Onkologie
Freiburg, Germany, 79106
UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie
Göttingen, Germany, 37099
Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation
Hamburg, Germany, 20099
Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe
Karlsruhe, Germany, 76135
Klinikum der Universität München - Großhadern, Medizinische Klinik III
München, Germany, 81377
Universitaetsklinikum Tuebingen
Tuebingen, Germany, 72076
Israel
Soroka Medical Center The Institute of Hematology
Beer Sheva, Israel, 84101
Davidoff Cancer Center The Institute of Hematology
Petah Tiqwa, Israel, 49100
Italy
Az. Osp. SS.Antonio e Biagio SC Ematologia
Alessandria, Italy, 15121
Ospedale Regionale di Bolzano - Divisione di Ematologia
Bolzano, Italy, 39100
Hematology Dept, Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50139
Azienda Ospedaliera Universitaria "San Martino"
Genova, Italy, 16132
Az. Osp. Ospedali Riuniti Papardo - Piemonte - S.C. Ematologia
Messina, Italy, 98158
A,O Ospedale Niguarda Ca Granda Dept Hematology
Milan, Italy, 20162
Fondazione San Raffaele del Monte Tabor I.R.C.C.S.
Milano, Italy, 20132
Istituto Nazionale Tumori Fondazione "G. Pascale" - Oncoematologia
Napoli, Italy, 80131
Università del Piemonte Orientale "Amedeo Avogadro"
Novara, Italy, 28100
Policlinico San Matteo - Dip. Di Ematologia
Pavia, Italy, 27100
Az. Osp. Bianchi Melacrino Morelli, Div. Di Ematologia
Reggio Calabria, Italy, 89100
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
Roma, Italy, 00168
IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia
S.Giovanni Rotondo (FG), Italy, 71013
Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette)
Torino, Italy, 10126
Ospedale Cardinale G. Panico - Ematologia e Immunoematologia
Tricase, Italy, 73039
Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria
Udine, Italy, 33100
Poland
Małopolskie Centrum Medyczne
Krakow, Poland, 30-510
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
Lodz, Poland, 93510
Dolnoslaskie Centrum Transplantacji Komórkowych
Wroclaw, Poland, 53439
Portugal
Serviço de Hematologia
Coimbra, Portugal, 300-075
Instituto Português de Oncologia (IPO) de Lisboa
Lisboa, Portugal, 1099-023
Instituto Português de Oncologia (IPO) do Porto
Porto, Portugal, 4200-072
Puerto Rico
Centro de Cancer, Hospital Espanol Auxilio de Puerto Rico
San Juan, Puerto Rico, 00918
Russian Federation
Sverdlovsk Regional Clinical Hospital - Volgogradskaya
Ekaterinburg, Russian Federation, 620102
Republican Clinical Oncological Dispensary
Kazan, Russian Federation, 420029
Russian Oncological Research Centre
Moscow, Russian Federation, 115478
Perm Regional Clinical Hospital
Perm, Russian Federation, 614600
Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov Rosmedtechnologies
St. Petersburg, Russian Federation, 197341
Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-biological agency
St. Petersburg, Russian Federation, 191024
State Educational Institution of High Professional Education
St. Petersburg, Russian Federation, 197022
State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1
Volgograd, Russian Federation, 400138
Spain
Hospital Universitario Vall d´Hebrón Hematology Department
Barcelona, Spain, 08035
Hospital de Madrid Norte- Sanchinarro
Madrid, Spain
Hospital Costa del Sol, Oncology
Marbella (Málaga), Spain, 29600
C. H. de Orense
Ourense, Spain
Clinica Universitaria de Navarra, Hematology
Pamplona, Spain, 31008
Hospital Clínico Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Marques de Valdecilla
Santander, Spain, 39008
United Kingdom
Kent and Canterbury Hospital
Canterbury, Kent, United Kingdom, CT1 3NG
Torbay Hospital
County of Devon, United Kingdom, TQ2 7AA
Royal Devon & Exeter Hospital
Exeter, United Kingdom, EX2 5DW
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 OXL
Barts & The London NHS Trust Medical Oncology
London, United Kingdom, EC1M 6BQ
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Salisbury NHS Foundation Trust, Haematology
Salisbury, United Kingdom, SP2 8BJ
St Helens Hospital, Lilac Lower Ground
St. Helens, United Kingdom, WA9 3DA
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: Martin Dreyling, Prof. Dr Medizinische Klinik III der Universität München
  More Information

No publications provided by Celgene Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01021423     History of Changes
Other Study ID Numbers: CC-5013-MCL-003
Study First Received: November 25, 2009
Results First Received: October 31, 2011
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic

Keywords provided by Celgene Corporation:
Mantle Cell Lymphoma
Non-Hodgkin's Lymphoma
CC-5013
Revlimid
Lenalidomide

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014