AzTrials
AzTrials

B-cell Chronic Lymphocytic LeukemiaPhase 3NCT00774345

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 study testing Lenalidomide in people with B-cell Chronic Lymphocytic Leukemia, run by Celgene at 241 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Chronic Lymphocytic Leukemia
What is being tested?
Lenalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
317 participants
Where
241 sitesin 25 countries
Study dates
27 Jan 2009to 27 Oct 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • Either commit to continued abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
  • Male subjects must:
  • Commit to continued abstinence from heterosexual contact or agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
  • Agree to not donate semen during study drug therapy and for a period after end of study drug therapy.
  • All subjects must:
  • Have an understanding that the study drug could have a potential teratogenic risk.
  • Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. • Agree not to share study medication with another person.
  • All subjects must be counseled about pregnancy precautions and risks of fetal exposure.

Who cannot join

  • 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.
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  • 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)
  • History of renal failure requiring dialysis.
  • Known Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), and/or active Hepatitis C Virus (HCV) infection.
  • Prior therapy with lenalidomide.
  • Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be enrolled upon correction of electrolyte abnormalities).
  • Any of the following laboratory abnormalities:
  • Calculated (method of Cockroft-Gault) creatinine clearance <60 mL/min.
  • Absolute neutrophil count (ANC) <1,000/μL (1.0 X 109/L)
  • Platelet count <50,000/μL (50 X 109/L)
  • Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN)
  • Serum total bilirubin >2.0 mg/dL (with the exception of Gilbert's Syndrome)
  • Grade 4 rash due to prior thalidomide treatment
  • Uncontrolled hyperthyroidism or hypothyroidism
  • Venous thromboembolism within one year
  • Greater than or equal to Grade-2 neuropathy
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  • Disease transformation (active) (ie, Richter's Syndrome, prolymphocytic leukemia)
  • Known allergy to allopurinol for subjects assessed with PR following their second-line induction therapy.
  • Prisoners.
  • More than 2 prior lines of CLL therapy.

Trial locations and contacts

241 sites in 25 countries.

241 sites in 25 countries

United States56 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • McFarland Clinic

    Ames, Iowa, 50010

  • Augusta Oncology Associates, P.C.

    Augusta, Georgia, 30901

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Boca Raton Community Hospital

    Boca Raton, Florida, 33486

  • Clinical Unit for Research Trials in Skin CURTIS Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Pasco Hernando Oncology Associates, PA

    Brooksville, Florida, 34613

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Charleston Hematology Oncology P.A.

    Charleston, South Carolina, 29403

  • Northwestern University, Division of Hematology Oncology, Dept. of Medicine

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Hematology Oncology Consultants, Inc.

    Columbus, Ohio, 43235

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218-1210

  • Gabrail Cancer Center Research

    Dover, Ohio, 44622

  • Pacific Coast Hematology Oncology

    Fountain Valley, California, 92708

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • The Cancer Center, Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426-3558

  • Edward Hines Jr VA Hospital

    Hines, Illinois, 60141

  • Memorial Hospital

    Hollywood, Florida, 33021

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Gundersen Clinic Lutheran Hospital

    La Crosse, Wisconsin, 54601

  • Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute

    Marietta, Georgia, 30060

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services

    New Albany, Indiana, 47150

  • Biomedical Research Alliance of New York, LLC

    New Hyde Park, New York, 11042

  • Ochsner Medical Institutions

    New Orleans, Louisiana, 70121

  • North Chicago VA Medical Center

    North Chicago, Illinois, 60064

  • Drexel University, College of Medicine, Clinical Research Group

    Philadelphia, Pennsylvania, 19102

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Cancer Center of Central Connecticut

    Plainville, Connecticut, 06062

  • Kaiser Permanente Northwest Oncology Hematology

    Portland, Oregon, 97227

  • Kaiser Permanente Medical Group

    San Diego, California, 92120

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101-1733

  • Hematology Oncology Assoc. of IL Orchard Research LLC

    Skokie, Illinois, 60076

  • Stanford University Stanford

    Stanford, California, 94305

  • M. Francisco Gonzalez, MD, PA

    Sumter, South Carolina, 29150

  • SUNY Upstate Medical University Medicine Oncology

    Syracuse, New York, 13215

  • Florida Cancer Specialist

    Tavares, Florida, 32778

  • Florida Hospital Cancer Institute Waterman

    Tavares, Florida, 32778

  • Westchester County Medical Center

    Valhalla, New York, 10595

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington, 98801

  • Abington Hematology Oncology Associates Inc

    Willow Grove, Pennsylvania, 19090

  • Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

  • Trilogy Cancer Care

    Wooster, Ohio, 44691

Other trials in United States

Italy25 sites

  • Azienda Ospedaliera Poloclinico di Bari

    Bari, 70124

  • Istituto dei Tumori Giovanni Paolo II di Bari

    Bari, 70124

  • AO Spedali Civili di Brescia

    Brescia, 25123

  • Azienda Ospedaliera Vittorio Emanuele-Ferrarotto

    Catania, 95124

  • A.O. Pugliese Ciaccio

    Catanzaro, 88100

  • Azienda Ospedaliera Annunziala

    Cosenza, 87100

  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

    Ferrara, 44100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50139

  • Azienda Ospedaliero Universitaria OORR Foggia

    Foggia, 71100

  • Azienda Ospedaliera San Martino

    Genova, 16132

  • IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

    Milan, 20122

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20132

  • Istituto Oncologico Europeo

    Milan, 20141

  • Azienda Ospedaliero Universitaria di Modena

    Modena, 41100

  • Ospedale Cardarelli

    Naples, 80131

  • Policlinico Universitario Federico II

    Naples, 80131

  • Universita del Piemonte Orientale

    Novara, 28100

  • Universita degli Studi di Padova

    Padova, 35128

  • Azienda Ospedaliera Ospedale San Carlo

    Potenza, 85100

  • Ospedale Sant'Eugenio

    Rome, 00144

  • Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

    Rome, 00161

  • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

    Siena, 53100

  • Osp. S.Giovanni Battista Le Molinette

    Torino, 10126

  • Ospedale Umberto I

    Torrette Di Ancona, 60020

  • Ospedale San Bortolo di Vicenza

    Vicenza, 36100

Other trials in Italy

Russia17 sites

  • Archangelsk Regional Clinical Hospital

    Arkhangelsk, 163045

  • City Hospital 8

    Barnaul, 659010

  • GMU Republic clinical hospital

    Kazan', 420012

  • Krasnoyarsk Regional Clinical Hospital

    Krasnoyarsk, 660022

  • Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl

    Moscow, 115447

  • State Budgetary Institution of the City of Moscow

    Moscow, 123182

  • NUZ Central Clinical Hospital

    Moscow, 129128

  • Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko

    Nizhny Novgorod, 603126

  • MUZ City Clinical Hospital 2

    Novosibirsk, 630051

  • Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so

    Obninsk, 249036

  • FGU Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency

    Saint Petersburg, 191024

  • GUS Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • St. Petersburg Pavlov State Medical Univ

    Saint Petersburg, 197022

  • Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies

    Saint Petersburg, 197341

  • Saratov State Medical University

    Saratov, 410012

  • GUZ Volgograd Regional Clinical Oncology

    Volgograd, 400138

  • State Healthcare Institution Sverdlovsk regional clinical hospital 1

    Yekaterinburg, 620102

Other trials in Russia

Spain14 sites

  • Hospital Germans Trias I Pujol

    Badalona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario Vall D hebron

    Barcelona, 08035

  • Hospital Donostia

    Donostia / San Sebastian, 20014

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro-Majadahonda

    Majadahonda, 28222

  • Virgen de la Victoria Hospital Malaga

    Málaga, 29010

  • Hospital General Universitario Morales Messeguer

    Murcia, 30008

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Clinico Universitario

    Valencia, 46010

Other trials in Spain

United Kingdom14 sites

  • Royal Bournemouth General Hospital

    Bournemouth, BH7 7DW

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Gartnavel General Hospital

    Glasgow, G12 0YN

  • John Radcliffe Hospital

    Headington, OX3 9DU

  • Saint James University Hospital

    Leeds, LS9 7TF

  • Royal Liverpool University Hospital

    Liverpool, L78XP

  • St. Bartholomew's and The Royal London Hospital

    London, EC1A 7BE

  • Guy's and St. Thomas' Hospital

    London, SE1 9RT

  • King's College Hospital

    London, SE5 9RS

  • St George's Healthcare NHS Trust

    London, SW17 0QT

  • Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX

  • Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

    Sheffield, S10 2JF

  • Singleton Hospital, Southwest Wales Cancer Inst

    Swansea, SA28QA

  • Sandwell Hospital

    West Bromwich, B71 4HJ

Other trials in United Kingdom

Australia13 sites

  • IMVS

    Adelaide, South Australia, 5000 SA

  • Flinders Medical Centre

    Bedford Park, 5042

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • Concord Hospital

    Concord, New South Wales, 2139

  • Peter MacCallum Cancer Centre

    East Melbourne, 3006

  • Frankston Hospital

    Farkston, 3199

  • St. Vincent Hospital

    Fitzroy, 3065

  • Nepean Hospital

    Kingswood, NSW, 2751

  • Clinical Trials Unit The St George Hospital

    Kogarah, 2217

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

  • Haematology and Oncology Clinics of Australasia

    South Brisbane, Queensland, 4101

  • Royal North Shore HospitalDepartment of HematologyLevel 4

    St Leonards, 2065

  • The Queen Elizabeth Hospital

    Woodville, 5011

Other trials in Australia

Germany13 sites

  • Charite, Campus Benjamin Franklin, Medizinische Klinik III

    Berlin, 12203

  • Klinikum der Universitat zu Koln

    Cologne, 50937

  • Universitaetsklinikum EssenZentrum fuer Innere Medizin

    Essen, 45122

  • Innere Medizin Klinikum Frankfurt Oder GmBH

    Frankfurt (Oder), 15236

  • Universitaetsklinikum FreiburgInnere Med.1, Haematologie

    Freiburg im Breisgau, 79106

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Praxis fuer Haematologie und Onkologie Koblenz

    Koblenz, 56068

  • Universitatsklinikum Leipzig

    Leipzig, 04103

  • Mannheimer Onkologie Praxis

    Mannheim, 68161

  • Stadtisches Klinikum Munchen GmbH

    München, 80804

  • TU München - Klinikum rechts der Isar

    München, 81675

  • Facharzte fur Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis

    Münster, 48149

  • University Hospital of Ulm

    Ulm, 89081

Other trials in Germany

France12 sites

  • Hopital Aviecenne

    Bobigny, 93009

  • Bergonie Institut

    Bordeaux, 33076

  • CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire

    Clermont-Ferrand, 63000

  • CHU Hopital Michallon

    Grenoble, 38043

  • Centre Hospitalier Lyon Sud

    Lyon, 69495

  • Cetre Hospitalier Hotel-Dieu

    Nantes, 44093

  • Hopital de l'Archet 1

    Nice, 06200

  • Hopital Petie- SalpetriereDepartment d'Hematologie

    Paris, Cedex 13

  • CHU La Miletrie

    Poitiers, 86021

  • CHU de Reims

    Reims, 51092

  • CLCC H BecquerelHematology

    Rouen, 76038

  • Hopital Bretonneau

    Tours, 37044

Other trials in France

Israel12 sites

  • Ha'Emek Medical Center

    Afula, 18101

  • Barzilai Medical Center

    Ashkelon, 78278

  • Soroka University Medical Center

    Beersheba, 84101

  • Bnei Zion Medical Center

    Haifa, 31048

  • Rambam Health Care Campus

    Haifa, 31096

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Meir Medical Center

    Kfar Saba, 44281

  • Western Galilee Hospital

    Nahariya, 22100

  • Rabin Medical Center

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center Department of Hematology

    Tel Aviv, 64239

  • Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Belgium8 sites

  • AZ Sint-Jan AV Brugge

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires St Luc

    Brussels, 1200

  • UZ Gent Hematology

    Ghent, 9000

  • Hopital de Jolimont

    Haine-Saint-Paul, 7100

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • CHU Mont -Godinne

    Yvoir, 5530

Other trials in Belgium

Canada8 sites

  • CDHA Centre for Clinical Research

    Halifax, Nova Scotia, B3H 1V7

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • CIUSSS de l'Est-de-l'Ile-de-Montreal

    Montreal/Quebec, Quebec

  • Hopital De L'Enfant-Jesus

    Québec, G1J 1Z4

  • Regional Health Authority B-Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • General Hospital, Eastern Health

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Hungary7 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

    Debrecen, 4032

  • Petz Aladar Country Hospital

    Győr, 9024

  • Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

  • Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar

    Pécs, 7624

  • Szegedi TudomanyegyetemII Belgyogyaszati Klinika

    Szeged, 6720

  • Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza

    Tatabánya

Other trials in Hungary

Czechia6 sites

  • Interni hematoonkologicka klinika

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Poliklinika Agel Novy Jicin

    Nový Jičín, 74101

  • Faculty Hospital Plzen

    Pilsen, 30460

  • Faculty Hospital Kralovske Vinohrady

    Prague, 100 00

  • General Faculty Hosital1.Internal Clinic

    Prague, 12808

Other trials in Czechia

Poland6 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Malopolskie Centrum Medyczne S.C.

    Krakow, 30-510

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

    Lodz, 93-510

  • Specjalistyczny Szpital miejski im. Kopernika

    Torun, 87-100

  • Centralny Szpital Kliniczny MON

    Warsaw, 04-141

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

    Wroclaw, 50-367

Other trials in Poland

Romania5 sites

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Clinic Coltea

    Bucharest, 030171

  • Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi

    Iași, 700111

  • Spitalul Clinic Judetean de Urgenta Sibiu

    Sibiu, 550245

  • Spitalul Clinic Municipal de Urgenta Timisoara

    Timișoara, 300079

Other trials in Romania

South Africa5 sites

  • Groote Schuur Hospital

    Cape Town

  • University Witwatersrand Oncology

    Parktown, 2193

  • Pretoria Academic Hospital

    Pretoria, 0002

  • Mary Potter Oncology Centre

    Pretoria

  • Wilgers Oncology CentreWilgrers Hospital

    Pretoria

Other trials in South Africa

Austria3 sites

  • Universitaetsklinik Innsbruck

    Innsbruck, 6020

  • Hospital Bamherzige Schwestern

    Linz, 4010

  • Medical University of Vienna Internalmedicine 1, Hematology

    Vienna, 1190

Other trials in Austria

Denmark3 sites

  • Rigshospitalet University Hospital

    Copenhagen, 2100

  • Odense University Hospital

    Odense, DK-5000

  • Vejle Hospital

    Vejle, 7100

Other trials in Denmark

New Zealand3 sites

  • Christchurch Hospital

    Christchurch

  • Middlemore Clinical Trials

    Manukau, 1640

  • North Shore Hospital

    Takapuna, 1309

Other trials in New Zealand

Portugal3 sites

  • Hospitais da Universidade de Coimbra

    Coimbra, 3000 - 075

  • Hospital de Dia de Hematologia

    Lisbon, 1649-035

  • Instituto Portugues Oncologia do Porto Francisco Gentil EPE

    Porto, 4200-072

Other trials in Portugal

Sweden3 sites

  • Skane University Hospital

    Lund, 221 85

  • Stockholm South Hospital

    Stockholm, 11883

  • Karolinska University

    Stockholm, 14186

Other trials in Sweden

Ireland2 sites

  • St James's Hospital

    Dublin, 8

  • Midwestern Regional Hospital

    Limerick

Other trials in Ireland

Colombia1 site

  • Oncomedica S.A.

    Montería

Other trials in Colombia

Mexico1 site

  • Instituto Biomedico de Investigacion AC

    Aguascalientes, 20127

Other trials in Mexico

Netherlands1 site

  • VU University Medical Center

    Amsterdam, 1081 HV

Other trials in Netherlands

About this study

Official title: 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)

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.

Read the detailed description

This is a phase 3, randomized (computer assigned by chance to treatment arm), study being completed an multiple sites to compare the safety and efficacy (how well a drug works) of lenalidomide maintenance therapy to placebo (dummy capsule that contains no lenalidomide or active substances) maintenance therapy.

Patients are assigned by a computer with a 50/50 chance to receive placebo or lenalidomide study treatment. Study drug will be taken once each day until the patient discontinues the study. Patients will remain on study drug until progression of disease.

Patients will visit their study doctor every 28 days until disease progression to complete safety and efficacy assessments. Quality of life assessments will be completed every other month. If a patient who discontinue study drug prior to disease progression (i.e. due to an adverse reaction to the study drug), they will continue to visit the study doctor each month to complete the efficacy assessments up to progression of disease. Safety assessments may include laboratory blood tests, ECG tests and questions about any medical conditions or side effects experienced during the study. Efficacy assessments may include laboratory blood tests and focused physical exams.

Computed tomography (CT) scans along with blood tests and bone marrow samples will be collected to confirm if a patient has improvement of response while on study.

After disease progression, patients will be contacted every 12 weeks for survival information, next CLL treatments and quality of life questions.

Subjects currently on lenalidomide treatment will discontinue lenalidomide treatment immediately and complete the Treatment Discontinuation assessment. The subjects will then transition to the survival follow-up period.

Being tested
Lenalidomide, Placebo
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called Revlimid

    Lenalidomide capsules given orally on days 1-28 of a 28 day cycle

  • PlaceboDrug

    Placebo capsules given orally on days 1 - 28 of a 28 day cycle

Study groups in NCT00774345
Study groupRoleWhat they receive
Experimental: 1ExperimentalLenalidomide po qd on days 1-28 of a 28 day cycle
Receives: Drug: Lenalidomide
Placebo Comparator: 2Placebo comparatorPlacebo capsules given orally on days 1-28 of a 28 day cycle
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 11 years

Secondary outcomes (2)

  1. Progression Free Survival 2 (PFS2)

    Progression Free Survival (PFS2) assessed by investigator is defined as the time from randomization to the second objective disease progression, or death from any cause, whichever occurs first.

    Measured: Up to 6 years

  2. Number of Participants With Adverse Events (AEs)

    Number of participants with adverse events (AEs) that measure type, frequency and severity of AEs graded by National Cancer Institute Common Terminology Criteria (NCI CTCAE V 3.0) including any grade adverse events (AEs), Grade 3-4 AEs, AEs related to study drug, grade 3-4 AEs related to study drug.

    Measured: From first dose to 30 days post last dose (up to 9 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2008 (estimated)
  2. Study start27 Jan 2009
  3. Primary completion27 Oct 2020
  4. Study completion27 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00774345
Sponsor's protocol ID
CC-5013-CLL-002
Status last verified
Nov 2021
First submitted
16 Oct 2008
Last updated
2 Dec 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28958469

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide in people with B-cell Chronic Lymphocytic Leukemia, run by Celgene at 241 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 241 sites in United States, Italy, Russia, Spain, United Kingdom and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 11 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00774345, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.

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