A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second-Line Therapy (The Continuum Trial)
1 other identifier
interventional
317
24 countries
238
Brief Summary
The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2009
Longer than P75 for phase_3
238 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2008
CompletedFirst Posted
Study publicly available on registry
October 17, 2008
CompletedStudy Start
First participant enrolled
January 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2020
CompletedResults Posted
Study results publicly available
December 2, 2021
CompletedDecember 2, 2021
November 1, 2021
11.8 years
October 16, 2008
October 27, 2021
November 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death from any cause. OS will be censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Up to approximately 11 years
Secondary Outcomes (2)
Progression Free Survival 2 (PFS2)
Up to 6 years
Number of Participants With Adverse Events (AEs)
From first dose to 30 days post last dose (up to 9 years)
Study Arms (2)
Experimental: 1
EXPERIMENTALLenalidomide po qd on days 1-28 of a 28 day cycle
Placebo Comparator: 2
PLACEBO COMPARATORPlacebo capsules given orally on days 1-28 of a 28 day cycle
Interventions
Lenalidomide capsules given orally on days 1-28 of a 28 day cycle
Eligibility Criteria
You may qualify if:
- Must understand and voluntarily sign an informed consent form.
- Must be greater than or equal to 18 years at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Must have a documented diagnosis of B-cell CLL (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia \[Hallek, 2008\]).
- Must have been treated with one of the following in first and/or second line:
- a purine analog-containing regimen
- a bendamustine-containing regimen
- an anti-CD20 antibody-containing regimen
- a chlorambucil-containing regimen
- an alemtuzumab-containing regimen (for those subjects with a 17p deletion)
- Must have achieved a minimum response of partial response (PR, nPR, CRi, CR, and MRD-negative CR) (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia \[Hallek, 2008\]) following completion of second-line induction therapy prior to randomization (documentation of response status must be available). Second-line induction therapy must be documented to have been of sufficient duration.
- Must have completed last cycle of second-line induction no less than 8 weeks (56 days) and no greater than 20 weeks (140 days) prior to randomization.
- Must have an ECOG performance status score of less than or equal to 2.
- Females of childbearing potential (FCBP)† must:
- Have two negative medically supervised pregnancy tests prior to starting of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices complete and continued sexual abstinence.
- +8 more criteria
You may not qualify if:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Active infections requiring systemic antibiotics.
- Systemic infection that has not resolved \> 2 months prior to initiating lenalidomide treatment in spite of adequate anti-infective therapy
- Autologous or allogeneic bone marrow transplant as second-line therapy.
- Pregnant or lactating females.
- Systemic treatment for B-cell CLL in the interval between completing the last cycle of second-line induction therapy and randomization.
- Participation in any clinical study or having taken any investigational therapy for a disease other than CLL within 28 days prior to initiating maintenance therapy.
- Known presence of alcohol and/or drug abuse.
- Central nervous system involvement as documented by spinal fluid cytology or imaging. Subjects who have signs or symptoms suggestive of leukemic meningitis or a history of leukemic meningitis must have a lumbar puncture procedure performed within two weeks prior to randomization.
- Prior history of malignancies, other than CLL, unless the subject has been free of the disease for ≥5 years. Exceptions include the following:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (241)
Mayo Clinic - Arizona
Phoenix, Arizona, 85054, United States
Pacific Coast Hematology Oncology
Fountain Valley, California, 92708, United States
Kaiser Permanente Medical Group
San Diego, California, 92120, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Stanford University Stanford
Stanford, California, 94305, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218-1210, United States
Cancer Center of Central Connecticut
Plainville, Connecticut, 06062, United States
Boca Raton Community Hospital
Boca Raton, Florida, 33486, United States
Pasco Hernando Oncology Associates, PA
Brooksville, Florida, 34613, United States
Memorial Hospital
Hollywood, Florida, 33021, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Florida Cancer Specialist
Tavares, Florida, 32778, United States
Florida Hospital Cancer Institute Waterman
Tavares, Florida, 32778, United States
Augusta Oncology Associates, P.C.
Augusta, Georgia, 30901, United States
Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute
Marietta, Georgia, 30060, United States
Northwestern University, Division of Hematology Oncology, Dept. of Medicine
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426-3558, United States
Edward Hines Jr VA Hospital
Hines, Illinois, 60141, United States
North Chicago VA Medical Center
North Chicago, Illinois, 60064, United States
Hematology Oncology Assoc. of IL Orchard Research LLC
Skokie, Illinois, 60076, United States
Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services
New Albany, Indiana, 47150, United States
McFarland Clinic
Ames, Iowa, 50010, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101-1733, United States
Ochsner Medical Institutions
New Orleans, Louisiana, 70121, United States
Clinical Unit for Research Trials in Skin CURTIS Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
The Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Biomedical Research Alliance of New York, LLC
New Hyde Park, New York, 11042, United States
SUNY Upstate Medical University Medicine Oncology
Syracuse, New York, 13215, United States
Westchester County Medical Center
Valhalla, New York, 10595, United States
Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Hematology Oncology Consultants, Inc.
Columbus, Ohio, 43235, United States
Gabrail Cancer Center Research
Dover, Ohio, 44622, United States
Trilogy Cancer Care
Wooster, Ohio, 44691, United States
Kaiser Permanente Northwest Oncology Hematology
Portland, Oregon, 97227, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Drexel University, College of Medicine, Clinical Research Group
Philadelphia, Pennsylvania, 19102, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Abington Hematology Oncology Associates Inc
Willow Grove, Pennsylvania, 19090, United States
Charleston Hematology Oncology P.A.
Charleston, South Carolina, 29403, United States
M. Francisco Gonzalez, MD, PA
Sumter, South Carolina, 29150, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801, United States
Gundersen Clinic Lutheran Hospital
La Crosse, Wisconsin, 54601, United States
Concord Hospital
Concord, New South Wales, 2139, Australia
Haematology and Oncology Clinics of Australasia
South Brisbane, Queensland, 4101, Australia
IMVS
Adelaide, South Australia, 5000 SA, Australia
Flinders Medical Centre
Bedford Park, 5042, Australia
Royal Prince Alfred Hospital
Camperdown, 2050, Australia
Peter MacCallum Cancer Centre
East Melbourne, 3006, Australia
Frankston Hospital
Farkston, 3199, Australia
St. Vincent Hospital
Fitzroy, 3065, Australia
Nepean Hospital
Kingswood, NSW, 2751, Australia
Clinical Trials Unit The St George Hospital
Kogarah, 2217, Australia
Sir Charles Gairdner Hospital
Nedlands, 6009, Australia
Royal North Shore HospitalDepartment of HematologyLevel 4
St Leonards, 2065, Australia
The Queen Elizabeth Hospital
Woodville, 5011, Australia
Universitaetsklinik Innsbruck
Innsbruck, 6020, Austria
Hospital Bamherzige Schwestern
Linz, 4010, Austria
Medical University of Vienna Internalmedicine 1, Hematology
Vienna, 1190, Austria
AZ Sint-Jan AV Brugge
Bruges, 8000, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
Cliniques Universitaires St Luc
Brussels, 1200, Belgium
UZ Gent Hematology
Ghent, 9000, Belgium
Hopital de Jolimont
Haine-Saint-Paul, 7100, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU Mont -Godinne
Yvoir, 5530, Belgium
Regional Health Authority B-Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
General Hospital, Eastern Health
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
CDHA Centre for Clinical Research
Halifax, Nova Scotia, B3H 1V7, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
McGill University
Montreal, Quebec, H2W 1S6, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
CIUSSS de l'Est-de-l'Ile-de-Montreal
Montreal/Quebec, Quebec, Canada
Hopital De L'Enfant-Jesus
Québec, G1J 1Z4, Canada
Oncomedica S.A.
Montería, Colombia
Interni hematoonkologicka klinika
Brno, 625 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Poliklinika Agel Novy Jicin
Nový Jičín, 74101, Czechia
Faculty Hospital Plzen
Pilsen, 30460, Czechia
Faculty Hospital Kralovske Vinohrady
Prague, 100 00, Czechia
General Faculty Hosital1.Internal Clinic
Prague, 12808, Czechia
Rigshospitalet University Hospital
Copenhagen, 2100, Denmark
Odense University Hospital
Odense, DK-5000, Denmark
Vejle Hospital
Vejle, 7100, Denmark
Hopital Aviecenne
Bobigny, 93009, France
Bergonie Institut
Bordeaux, 33076, France
CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire
Clermont-Ferrand, 63000, France
CHU Hopital Michallon
Grenoble, 38043, France
Centre Hospitalier Lyon Sud
Lyon, 69495, France
Cetre Hospitalier Hotel-Dieu
Nantes, 44093, France
Hopital de l'Archet 1
Nice, 06200, France
Hopital Petie- SalpetriereDepartment d'Hematologie
Paris, Cedex 13, France
CHU La Miletrie
Poitiers, 86021, France
CHU de Reims
Reims, 51092, France
CLCC H BecquerelHematology
Rouen, 76038, France
Hopital Bretonneau
Tours, 37044, France
Charite, Campus Benjamin Franklin, Medizinische Klinik III
Berlin, 12203, Germany
Klinikum der Universitat zu Koln
Cologne, 50937, Germany
Universitaetsklinikum EssenZentrum fuer Innere Medizin
Essen, 45122, Germany
Innere Medizin Klinikum Frankfurt Oder GmBH
Frankfurt (Oder), 15236, Germany
Universitaetsklinikum FreiburgInnere Med.1, Haematologie
Freiburg im Breisgau, 79106, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Praxis fuer Haematologie und Onkologie Koblenz
Koblenz, 56068, Germany
Universitatsklinikum Leipzig
Leipzig, 04103, Germany
Mannheimer Onkologie Praxis
Mannheim, 68161, Germany
Stadtisches Klinikum Munchen GmbH
München, 80804, Germany
TU München - Klinikum rechts der Isar
München, 81675, Germany
Facharzte fur Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis
Münster, 48149, Germany
University Hospital of Ulm
Ulm, 89081, Germany
Semmelweis Egyetem
Budapest, 1083, Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, 4032, Hungary
Petz Aladar Country Hospital
Győr, 9024, Hungary
Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar
Pécs, 7624, Hungary
Szegedi TudomanyegyetemII Belgyogyaszati Klinika
Szeged, 6720, Hungary
Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza
Tatabánya, Hungary
St James's Hospital
Dublin, 8, Ireland
Midwestern Regional Hospital
Limerick, Ireland
Ha'Emek Medical Center
Afula, 18101, Israel
Barzilai Medical Center
Ashkelon, 78278, Israel
Soroka University Medical Center
Beersheba, 84101, Israel
Bnei Zion Medical Center
Haifa, 31048, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Western Galilee Hospital
Nahariya, 22100, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Tel Aviv Sourasky Medical Center Department of Hematology
Tel Aviv, 64239, Israel
Sheba Medical Center
Tel Litwinsky, 52621, Israel
Azienda Ospedaliera Poloclinico di Bari
Bari, 70124, Italy
Istituto dei Tumori Giovanni Paolo II di Bari
Bari, 70124, Italy
AO Spedali Civili di Brescia
Brescia, 25123, Italy
Azienda Ospedaliera Vittorio Emanuele-Ferrarotto
Catania, 95124, Italy
A.O. Pugliese Ciaccio
Catanzaro, 88100, Italy
Azienda Ospedaliera Annunziala
Cosenza, 87100, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Ferrara, 44100, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50139, Italy
Azienda Ospedaliero Universitaria OORR Foggia
Foggia, 71100, Italy
Azienda Ospedaliera San Martino
Genova, 16132, Italy
IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Milan, 20122, Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20132, Italy
Istituto Oncologico Europeo
Milan, 20141, Italy
Azienda Ospedaliero Universitaria di Modena
Modena, 41100, Italy
Ospedale Cardarelli
Naples, 80131, Italy
Policlinico Universitario Federico II
Naples, 80131, Italy
Universita del Piemonte Orientale
Novara, 28100, Italy
Universita degli Studi di Padova
Padua, 35128, Italy
Azienda Ospedaliera Ospedale San Carlo
Potenza, 85100, Italy
Ospedale Sant'Eugenio
Rome, 00144, Italy
Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
Rome, 00161, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, 53100, Italy
Osp. S.Giovanni Battista Le Molinette
Torino, 10126, Italy
Ospedale Umberto I
Torrette Di Ancona, 60020, Italy
Ospedale San Bortolo di Vicenza
Vicenza, 36100, Italy
Instituto Biomedico de Investigacion AC
Aguascalientes, 20127, Mexico
VU University Medical Center
Amsterdam, 1081 HV, Netherlands
Christchurch Hospital
Christchurch, New Zealand
Middlemore Clinical Trials
Manukau, 1640, New Zealand
North Shore Hospital
Takapuna, 1309, New Zealand
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Malopolskie Centrum Medyczne S.C.
Krakow, 30-510, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, 93-510, Poland
Specjalistyczny Szpital miejski im. Kopernika
Torun, 87-100, Poland
Centralny Szpital Kliniczny MON
Warsaw, 04-141, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, 50-367, Poland
Hospitais da Universidade de Coimbra
Coimbra, 3000 - 075, Portugal
Hospital de Dia de Hematologia
Lisbon, 1649-035, Portugal
Instituto Portugues Oncologia do Porto Francisco Gentil EPE
Porto, 4200-072, Portugal
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Spitalul Clinic Coltea
Bucharest, 030171, Romania
Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi
Iași, 700111, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, 550245, Romania
Spitalul Clinic Municipal de Urgenta Timisoara
Timișoara, 300079, Romania
Archangelsk Regional Clinical Hospital
Arkhangelsk, 163045, Russia
City Hospital 8
Barnaul, 659010, Russia
GMU Republic clinical hospital
Kazan', 420012, Russia
Krasnoyarsk Regional Clinical Hospital
Krasnoyarsk, 660022, Russia
Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl
Moscow, 115447, Russia
State Budgetary Institution of the City of Moscow
Moscow, 123182, Russia
NUZ Central Clinical Hospital
Moscow, 129128, Russia
Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
Nizhny Novgorod, 603126, Russia
MUZ City Clinical Hospital 2
Novosibirsk, 630051, Russia
Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so
Obninsk, 249036, Russia
FGU Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency
Saint Petersburg, 191024, Russia
GUS Leningrad Regional Clinical Hospital
Saint Petersburg, 194291, Russia
St. Petersburg Pavlov State Medical Univ
Saint Petersburg, 197022, Russia
Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies
Saint Petersburg, 197341, Russia
Saratov State Medical University
Saratov, 410012, Russia
GUZ Volgograd Regional Clinical Oncology
Volgograd, 400138, Russia
State Healthcare Institution Sverdlovsk regional clinical hospital 1
Yekaterinburg, 620102, Russia
Groote Schuur Hospital
Cape Town, South Africa
University Witwatersrand Oncology
Parktown, 2193, South Africa
Pretoria Academic Hospital
Pretoria, 0002, South Africa
Mary Potter Oncology Centre
Pretoria, South Africa
Wilgers Oncology CentreWilgrers Hospital
Pretoria, South Africa
Hospital Germans Trias I Pujol
Badalona, 08916, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitario Vall D hebron
Barcelona, 08035, Spain
Hospital Donostia
Donostia / San Sebastian, 20014, Spain
Hospital Universitario de la Princesa
Madrid, 28006, Spain
Hospital Ramon y Cajal
Madrid, 28034, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, 28222, Spain
Virgen de la Victoria Hospital Malaga
Málaga, 29010, Spain
Hospital General Universitario Morales Messeguer
Murcia, 30008, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Hospital Clinico Universitario
Valencia, 46010, Spain
Skane University Hospital
Lund, 221 85, Sweden
Stockholm South Hospital
Stockholm, 11883, Sweden
Karolinska University
Stockholm, 14186, Sweden
Royal Bournemouth General Hospital
Bournemouth, BH7 7DW, United Kingdom
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Gartnavel General Hospital
Glasgow, G12 0YN, United Kingdom
John Radcliffe Hospital
Headington, OX3 9DU, United Kingdom
Saint James University Hospital
Leeds, LS9 7TF, United Kingdom
Royal Liverpool University Hospital
Liverpool, L78XP, United Kingdom
St. Bartholomew's and The Royal London Hospital
London, EC1A 7BE, United Kingdom
Guy's and St. Thomas' Hospital
London, SE1 9RT, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
St George's Healthcare NHS Trust
London, SW17 0QT, United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
Sheffield, S10 2JF, United Kingdom
Singleton Hospital, Southwest Wales Cancer Inst
Swansea, SA28QA, United Kingdom
Sandwell Hospital
West Bromwich, B71 4HJ, United Kingdom
Related Publications (1)
Chanan-Khan AA, Zaritskey A, Egyed M, Vokurka S, Semochkin S, Schuh A, Kassis J, Simpson D, Zhang J, Purse B, Foa R. Lenalidomide maintenance therapy in previously treated chronic lymphocytic leukaemia (CONTINUUM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2017 Nov;4(11):e534-e543. doi: 10.1016/S2352-3026(17)30168-0. Epub 2017 Sep 25.
PMID: 28958469DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Richard Delarue, MD
Celgene Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2008
First Posted
October 17, 2008
Study Start
January 27, 2009
Primary Completion
October 27, 2020
Study Completion
October 27, 2020
Last Updated
December 2, 2021
Results First Posted
December 2, 2021
Record last verified: 2021-11