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

November 24, 2021 updated by: Celgene

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

317

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Flinders Medical Centre
      • Camperdown, Australia, 2050
        • Royal Prince Alfred Hospital
      • East Melbourne, Australia, 3006
        • Peter Maccallum Cancer Centre
      • Farkston, Australia, 3199
        • Frankston Hospital
      • Fitzroy, Australia, 3065
        • St. Vincent Hospital
      • Kingswood, NSW, Australia, 2751
        • Nepean Hospital
      • Kogarah, Australia, 2217
        • Clinical Trials Unit The St George Hospital
      • Nedlands, Australia, 6009
        • Sir Charles Gairdner Hospital
      • St. Leonards, Australia, 2065
        • Royal North Shore HospitalDepartment of HematologyLevel 4
      • Woodville, Australia, 5011
        • The Queen Elizabeth Hospital
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Hospital
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Haematology and Oncology Clinics of Australasia
    • South Australia
      • Adelaide, South Australia, Australia, 5000 SA
        • IMVS
  • Austria
      • Innsbruck, Austria, 6020
        • Universitaetsklinik Innsbruck
      • Linz, Austria, 4010
        • Hospital Bamherzige Schwestern
      • Vienna, Austria, 1190
        • Medical University of Vienna Internalmedicine 1, Hematology
  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint-Jan AV Brugge
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St Luc
      • Gent, Belgium, 9000
        • UZ Gent Hematology
      • Haine-Saint Paul, Belgium, 7100
        • Hôpital de Jolimont
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Yvoir, Belgium, 5530
        • CHU Mont -Godinne
  • Canada
      • Quebec, Canada, G1J 1Z4
        • Hôpital de L'Enfant-Jésus
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Regional Health Authority B-Saint John Regional Hospital
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1B 3V6
        • General Hospital, Eastern Health
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • CDHA Centre for Clinical Research
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University
      • Montreal, Quebec, Canada, H4J 1C5
        • Hôpital du Sacré-Coeur de Montréal
      • Montreal/Quebec, Quebec, Canada
        • CIUSSS de l'Est-de-l'Île-de-Montréal
  • Colombia
      • Monteria, Colombia
        • Oncomedica S.A.
  • Czechia
      • Brno, Czechia, 625 00
        • Interni hematoonkologicka klinika
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Novy Jicin, Czechia, 74101
        • Poliklinika Agel Novy Jicin
      • Plzen, Czechia, 30460
        • Faculty Hospital Plzen
      • Prague, Czechia, 100 00
        • Faculty Hospital Kralovske Vinohrady
      • Prague, Czechia, 12808
        • General Faculty Hosital1.Internal Clinic
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet University Hospital
      • Odense, Denmark, DK-5000
        • Odense University Hospital
      • Vejle, Denmark, 7100
        • Vejle Hospital
  • France
      • Bobigny Cedex, France, 93009
        • Hopital Aviecenne
      • Bordeaux, France, 33076
        • Bergonié Institut
      • Clermont Ferrand, France, 63000
        • CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire
      • Grenoble Cedex 09, France, 38043
        • CHU Hopital Michallon
      • Lyon, France, 69495
        • Centre Hospitalier Lyon Sud
      • Nantes cedex 01, France, 44093
        • Cetre Hospitalier Hotel-Dieu
      • Nice, France, 06200
        • Hôpital de l'Archet 1
      • Paris, France, Cedex 13
        • Hopital Petie- SalpetriereDepartment d'Hematologie
      • Poitiers, France, 86021
        • CHU La Milétrie
      • Reims cedex, France, 51092
        • CHU de Reims
      • Rouen, France, 76038
        • CLCC H BecquerelHematology
      • Tours Cedex, France, 37044
        • Hôpital Bretonneau
  • Germany
      • Berlin, Germany, 12203
        • Charite, Campus Benjamin Franklin, Medizinische Klinik III
      • Essen, Germany, 45122
        • Universitaetsklinikum EssenZentrum fuer Innere Medizin
      • Frankfurt (Oder), Germany, 15236
        • Innere Medizin Klinikum Frankfurt Oder GmBH
      • Freiburg, Germany, 79106
        • Universitaetsklinikum FreiburgInnere Med.1, Haematologie
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Koblenz, Germany, 56068
        • Praxis fuer Haematologie und Onkologie Koblenz
      • Köln, Germany, 50937
        • Klinikum der Universität zu Köln
      • Leipzig, Germany, 04103
        • Universitatsklinikum Leipzig
      • Mannheim, Germany, 68161
        • Mannheimer Onkologie Praxis
      • München, Germany, 81675
        • TU München - Klinikum rechts der Isar
      • München, Germany, 80804
        • Städtisches Klinikum München GmbH
      • Münster, Germany, 48149
        • Facharzte fur Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis
      • Ulm, Germany, 89081
        • University Hospital of Ulm
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
      • Gyor, Hungary, 9024
        • Petz Aladar Country Hospital
      • Kaposvar, Hungary, 7400
        • Kaposi Mór Oktató Kórház
      • Pecs, Hungary, 7624
        • Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar
      • Szeged, Hungary, 6720
        • Szegedi TudomanyegyetemII Belgyogyaszati Klinika
      • Tatabanya, Hungary
        • Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza
  • Ireland
      • Dublin, Ireland, 8
        • St James's Hospital
      • Limerick, Ireland
        • Midwestern Regional Hospital
  • Israel
      • Afula, Israel, 18101
        • Ha'Emek Medical Center
      • Ashkelon, Israel, 78278
        • Barzilai Medical Center
      • Beer Sheva, Israel, 84101
        • Soroka University Medical Center
      • Haifa, Israel, 31096
        • Rambam Health Care Campus
      • Haifa, Israel, 31048
        • Bnei Zion Medical Center
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
      • Kfar-Saba, Israel, 44281
        • Meir Medical Center
      • Naharia, Israel, 22100
        • Western Galilee Hospital
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center Department of Hematology
      • Tel Hashomer, Israel, 52621
        • Sheba Medical Center
  • Italy
      • Bari, Italy, 70124
        • Azienda Ospedaliera Poloclinico di Bari
      • Bari, Italy, 70124
        • Istituto dei Tumori Giovanni Paolo II di Bari
      • Brescia, Italy, 25123
        • AO Spedali Civili di Brescia
      • Catania, Italy, 95124
        • Azienda Ospedaliera Vittorio Emanuele-Ferrarotto
      • Catanzaro, Italy, 88100
        • A.O. Pugliese Ciaccio
      • Cosenza, Italy, 87100
        • Azienda Ospedaliera Annunziala
      • Ferrara, Italy, 44100
        • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
      • Florence, Italy, 50139
        • Azienda Ospedaliera Universitaria Careggi
      • Foggia, Italy, 71100
        • Azienda Ospedaliero Universitaria OORR Foggia
      • Genova, Italy, 16132
        • Azienda Ospedaliera San Martino
      • Milan, Italy, 20122
        • IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
      • Milano, Italy, 20132
        • Fondazione Centro San Raffaele del Monte Tabor
      • Milano, Italy, 20141
        • Istituto Oncologico Europeo
      • Modena, Italy, 41100
        • Azienda Ospedaliero Universitaria di Modena
      • Naples, Italy, 80131
        • Ospedale Cardarelli
      • Naples, Italy, 80131
        • Policlinico Universitario Federico II
      • Novara, Italy, 28100
        • Università del Piemonte orientale
      • Padova, Italy, 35128
        • Universita degli Studi di Padova
      • Potenza, Italy, 85100
        • Azienda Ospedaliera Ospedale San Carlo
      • Rome, Italy, 00144
        • Ospedale Sant'Eugenio
      • Rome, Italy, 00161
        • Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
      • Torino, Italy, 10126
        • Osp. S.Giovanni Battista Le Molinette
      • Torrette Di Ancona, Italy, 60020
        • Ospedale Umberto I
      • Vicenza, Italy, 36100
        • Ospedale San Bortolo di Vicenza
  • Mexico
      • Aguascalientes, Mexico, 20127
        • Instituto Biomedico de Investigacion AC
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU University Medical Center
  • New Zealand
      • Christchurch, New Zealand
        • Christchurch Hospital
      • Manukau, New Zealand, 1640
        • Middlemore Clinical Trials
      • Takapuna, New Zealand, 1309
        • North Shore Hospital
  • Poland
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Kraków, Poland, 30-510
        • Malopolskie Centrum Medyczne s.c.
      • Lodz, Poland, 93-510
        • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
      • Torun, Poland, 87-100
        • Specjalistyczny Szpital miejski im. Kopernika
      • Warszawa, Poland, 04-141
        • Centralny Szpital Kliniczny MON
      • Wroclaw, Poland, 50-367
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
  • Portugal
      • Coimbra, Portugal, 3000 - 075
        • Hospitais da universidade de Coimbra
      • Lisbon, Portugal, 1649-035
        • Hospital de Dia de Hematologia
      • Porto, Portugal, 4200-072
        • Instituto Portugues Oncologia do Porto Francisco Gentil EPE
  • Romania
      • Bucharest, Romania, 022328
        • Institutul Clinic Fundeni
      • Bucharest, Romania, 030171
        • Spitalul Clinic Coltea
      • Iasi, Romania, 700111
        • Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi
      • Sibiu, Romania, 550245
        • Spitalul Clinic Judetean De Urgenta Sibiu
      • Timisoara, Romania, 300079
        • Spitalul Clinic Municipal de Urgenta Timisoara
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Archangelsk Regional Clinical Hospital
      • Barnaul, Russian Federation, 659010
        • City Hospital 8
      • Ekaterinburg, Russian Federation, 620102
        • State Healthcare Institution Sverdlovsk regional clinical hospital 1
      • Kazan, Russian Federation, 420012
        • GMU Republic clinical hospital
      • Krasnoyarsk, Russian Federation, 660022
        • Krasnoyarsk Regional Clinical Hospital
      • Moscow, Russian Federation, 115447
        • Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl
      • Moscow, Russian Federation, 123182
        • State Budgetary Institution of the City of Moscow
      • Moscow, Russian Federation, 129128
        • NUZ Central Clinical Hospital
      • Nizhniy Novgorod, Russian Federation, 603126
        • Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
      • Novosibirsk, Russian Federation, 630051
        • MUZ City Clinical Hospital 2
      • Obninsk, Russian Federation, 249036
        • Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so
      • Saratov, Russian Federation, 410012
        • Saratov State Medical University
      • St. Petersburg, Russian Federation, 191024
        • FGU Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency
      • St. Petersburg, Russian Federation, 194291
        • GUS Leningrad Regional Clinical Hospital
      • St. Petersburg, Russian Federation, 197341
        • Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies
      • St.Petersburg, Russian Federation, 197022
        • St. Petersburg Pavlov State Medical Univ
      • Volgograd, Russian Federation, 400138
        • GUZ Volgograd Regional Clinical Oncology
  • South Africa
      • Cape Town, South Africa
        • Groote Schuur Hospital
      • Parktown, South Africa, 2193
        • University Witwatersrand Oncology
      • Pretoria, South Africa
        • Mary Potter Oncology Centre
      • Pretoria, South Africa, 0002
        • Pretoria Academic Hospital
      • Pretoria, South Africa
        • Wilgers Oncology CentreWilgrers Hospital
  • Spain
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d Hebron
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta de Hierro-Majadahonda
      • Malaga, Spain, 29010
        • Virgen de la Victoria Hospital Malaga
      • Murcia, Spain, 30008
        • Hospital General Universitario Morales Messeguer
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • San Sebastian, Spain, 20014
        • Hospital Donostia
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario
  • Sweden
      • Lund, Sweden, 221 85
        • Skåne University Hospital
      • Stockholm, Sweden, 14186
        • Karolinska University
      • Stockholm, Sweden, 11883
        • Stockholm South Hospital
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth General Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
      • Glasgow, United Kingdom, G12 0YN
        • Gartnavel General Hospital
      • Headington, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
      • Leeds, United Kingdom, LS9 7TF
        • Saint James University Hospital
      • Liverpool, United Kingdom, L78XP
        • Royal Liverpool University Hospital
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, SW17 0QT
        • St George's Healthcare NHS Trust
      • London, United Kingdom, SE1 9RT
        • Guy's and St. Thomas' Hospital
      • London, United Kingdom, EC1A 7BE
        • St. Bartholomew's and The Royal London Hospital
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Foundation Trust
      • Sheffield, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
      • Swansea, United Kingdom, SA28QA
        • Singleton Hospital, Southwest Wales Cancer Inst
      • West Bromwich, United Kingdom, B71 4HJ
        • Sandwell Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic - Arizona
    • California
      • Fountain Valley, California, United States, 92708
        • Pacific Coast Hematology Oncology
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Diego, California, United States, 92120
        • Kaiser Permanente Medical Group
      • Stanford, California, United States, 94305
        • Stanford University Stanford
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Denver, Colorado, United States, 80218-1210
        • Rocky Mountain Cancer Center
    • Connecticut
      • Plainville, Connecticut, United States, 06062
        • Cancer Center of Central Connecticut
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Community Hospital
      • Brooksville, Florida, United States, 34613
        • Pasco Hernando Oncology Associates, PA
      • Hollywood, Florida, United States, 33021
        • Memorial Hospital
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Jacksonville
      • Tavares, Florida, United States, 32778
        • Florida Cancer Specialist
      • Tavares, Florida, United States, 32778
        • Florida Hospital Cancer Institute Waterman
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Augusta Oncology Associates, P.C.
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Division of Hematology Oncology, Dept. of Medicine
      • Harvey, Illinois, United States, 60426-3558
        • Ingalls Memorial Hospital
      • Hines, Illinois, United States, 60141
        • Edward Hines Jr VA Hospital
      • North Chicago, Illinois, United States, 60064
        • North Chicago VA Medical Center
      • Skokie, Illinois, United States, 60076
        • Hematology Oncology Assoc. of IL Orchard Research LLC
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic
      • Sioux City, Iowa, United States, 51101-1733
        • Siouxland Hematology-Oncology Associates, LLP
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Institutions
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Clinical Unit for Research Trials in Skin CURTIS Massachusetts General Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Nevada Cancer Research Foundation
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • The Cancer Center, Hackensack University Medical Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New Hyde Park, New York, United States, 11042
        • Biomedical Research Alliance of New York, LLC
      • Syracuse, New York, United States, 13215
        • SUNY Upstate Medical University Medicine Oncology
      • Valhalla, New York, United States, 10595
        • Westchester County Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center Research
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43235
        • Hematology Oncology Consultants, Inc.
      • Dover, Ohio, United States, 44622
        • Gabrail Cancer Center Research
      • Wooster, Ohio, United States, 44691
        • Trilogy Cancer Care
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Northwest Oncology Hematology
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Gettysburg, Pennsylvania, United States, 17325
        • Gettysburg Cancer Center
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University, College of Medicine, Clinical Research Group
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Hospital
      • Willow Grove, Pennsylvania, United States, 19090
        • Abington Hematology Oncology Associates Inc
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology P.A.
      • Sumter, South Carolina, United States, 29150
        • M. Francisco Gonzalez, MD, PA
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital and Clinics
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Clinic Lutheran Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Must understand and voluntarily sign an informed consent form.
  2. Must be greater than or equal to 18 years at the time of signing the informed consent form.
  3. Must be able to adhere to the study visit schedule and other protocol requirements.
  4. Must have a documented diagnosis of B-cell CLL (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia [Hallek, 2008]).

  5. 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)
  6. 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.
  7. 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.
  8. Must have an ECOG performance status score of less than or equal to 2.

  9. 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.

  10. 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.

  11. 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.

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  2. Active infections requiring systemic antibiotics.
  3. Systemic infection that has not resolved > 2 months prior to initiating lenalidomide treatment in spite of adequate anti-infective therapy
  4. Autologous or allogeneic bone marrow transplant as second-line therapy.
  5. Pregnant or lactating females.
  6. Systemic treatment for B-cell CLL in the interval between completing the last cycle of second-line induction therapy and randomization.
  7. 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.
  8. Known presence of alcohol and/or drug abuse.
  9. 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.

  10. 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)
  11. History of renal failure requiring dialysis.
  12. Known Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), and/or active Hepatitis C Virus (HCV) infection.
  13. Prior therapy with lenalidomide.
  14. Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be enrolled upon correction of electrolyte abnormalities).

  15. 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)
  16. Grade 4 rash due to prior thalidomide treatment
  17. Uncontrolled hyperthyroidism or hypothyroidism
  18. Venous thromboembolism within one year
  19. Greater than or equal to Grade-2 neuropathy
  20. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  21. Disease transformation (active) (ie, Richter's Syndrome, prolymphocytic leukemia)
  22. Known allergy to allopurinol for subjects assessed with PR following their second-line induction therapy.
  23. Prisoners.
  24. More than 2 prior lines of CLL therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: 1
Lenalidomide po qd on days 1-28 of a 28 day cycle
Drug: Lenalidomide
Lenalidomide capsules given orally on days 1-28 of a 28 day cycle
Other Names:
  • Revlimid
Placebo Comparator: Placebo Comparator: 2
Placebo capsules given orally on days 1-28 of a 28 day cycle
Drug: Placebo
Placebo capsules given orally on days 1 - 28 of a 28 day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 11 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival 2 (PFS2)
Time Frame: Up to 6 years
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.
Up to 6 years
Number of Participants With Adverse Events (AEs)
Time Frame: From first dose to 30 days post last dose (up to 9 years)
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.
From first dose to 30 days post last dose (up to 9 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Richard Delarue, MD, Celgene Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2009

Primary Completion (Actual)

October 27, 2020

Study Completion (Actual)

October 27, 2020

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 16, 2008

First Posted (Estimate)

October 17, 2008

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-CLL-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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