Clinical trial NCT00774345: 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: B-cell Chronic Lymphocytic Leukemia
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2008-10-17
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 11 years
Secondary outcomes:
measure: Progression Free Survival 2 (PFS2)
timeFrame: Up to 6 years
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose to 30 days post last dose (up to 9 years)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic - Arizona
state: Arizona
city: Fountain Valley
country: United States
facility: Pacific Coast Hematology Oncology
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Medical Group
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Stanford
country: United States
facility: Stanford University Stanford
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Plainville
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Boca Raton
country: United States
facility: Boca Raton Community Hospital
state: Florida
city: Brooksville
country: United States
facility: Pasco Hernando Oncology Associates, PA
state: Florida
city: Hollywood
country: United States
facility: Memorial Hospital
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Tavares
country: United States
facility: Florida Cancer Specialist
state: Florida
city: Tavares
country: United States
facility: Florida Hospital Cancer Institute Waterman
state: Florida
city: Augusta
country: United States
facility: Augusta Oncology Associates, P.C.
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute
state: Georgia
city: Chicago
country: United States
facility: Northwestern University, Division of Hematology Oncology, Dept. of Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Hines
country: United States
facility: Edward Hines Jr VA Hospital
state: Illinois
city: North Chicago
country: United States
facility: North Chicago VA Medical Center
state: Illinois
city: Skokie
country: United States
facility: Hematology Oncology Assoc. of IL Orchard Research LLC
state: Illinois
city: New Albany
country: United States
facility: Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates, LLP
state: Iowa
city: New Orleans
country: United States
facility: Ochsner Medical Institutions
state: Louisiana
city: Boston
country: United States
facility: Clinical Unit for Research Trials in Skin CURTIS Massachusetts General Hospital
state: Massachusetts
city: Las Vegas
country: United States
facility: Nevada Cancer Research Foundation
state: Nevada
city: Hackensack
country: United States
facility: The Cancer Center, Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Biomedical Research Alliance of New York, LLC
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Medicine Oncology
state: New York
city: Valhalla
country: United States
facility: Westchester County Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Hematology Oncology Consultants, Inc.
state: Ohio
city: Dover
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Wooster
country: United States
facility: Trilogy Cancer Care
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente Northwest Oncology Hematology
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University, College of Medicine, Clinical Research Group
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Hematology Oncology Associates Inc
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology P.A.
state: South Carolina
city: Sumter
country: United States
facility: M. Francisco Gonzalez, MD, PA
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital and Clinics
state: Washington
city: La Crosse
country: United States
facility: Gundersen Clinic Lutheran Hospital
state: Wisconsin
city: Concord
country: Australia
facility: Concord Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Haematology and Oncology Clinics of Australasia
state: Queensland
city: Adelaide
country: Australia
facility: IMVS
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Farkston
country: Australia
facility: Frankston Hospital
city: Fitzroy
country: Australia
facility: St. Vincent Hospital
city: Kingswood, NSW
country: Australia
facility: Nepean Hospital
city: Kogarah
country: Australia
facility: Clinical Trials Unit The St George Hospital
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
city: St. Leonards
country: Australia
facility: Royal North Shore HospitalDepartment of HematologyLevel 4
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
city: Innsbruck
country: Austria
facility: Universitaetsklinik Innsbruck
city: Linz
country: Austria
facility: Hospital Bamherzige Schwestern
city: Vienna
country: Austria
facility: Medical University of Vienna Internalmedicine 1, Hematology
city: Brugge
country: Belgium
facility: AZ Sint-Jan AV Brugge
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St Luc
city: Gent
country: Belgium
facility: UZ Gent Hematology
city: Haine-Saint Paul
country: Belgium
facility: Hopital de Jolimont
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Yvoir
country: Belgium
facility: CHU Mont -Godinne
city: Saint John
country: Canada
facility: Regional Health Authority B-Saint John Regional Hospital
state: New Brunswick
city: St John's
country: Canada
facility: General Hospital, Eastern Health
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: CDHA Centre for Clinical Research
state: Nova Scotia
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal/Quebec
country: Canada
facility: CIUSSS de l'Est-de-l'Ile-de-Montreal
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Quebec
city: Quebec
country: Canada
facility: Hopital De L'Enfant-Jesus
city: Monteria
country: Colombia
facility: Oncomedica S.A.
city: Brno
country: Czechia
facility: Interni hematoonkologicka klinika
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Novy Jicin
country: Czechia
facility: Poliklinika Agel Novy Jicin
city: Plzen
country: Czechia
facility: Faculty Hospital Plzen
city: Prague
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady
city: Prague
country: Czechia
facility: General Faculty Hosital1.Internal Clinic
city: Copenhagen
country: Denmark
facility: Rigshospitalet University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Bobigny Cedex
country: France
facility: Hopital Aviecenne
city: Bordeaux
country: France
facility: Bergonie Institut
city: Clermont Ferrand
country: France
facility: CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire
city: Grenoble Cedex 09
country: France
facility: CHU Hopital Michallon
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Nantes cedex 01
country: France
facility: Cetre Hospitalier Hotel-Dieu
city: Nice
country: France
facility: Hopital de l'Archet 1
city: Paris
country: France
facility: Hopital Petie- SalpetriereDepartment d'Hematologie
city: Poitiers
country: France
facility: CHU La Miletrie
city: Reims cedex
country: France
facility: CHU de Reims
city: Rouen
country: France
facility: CLCC H BecquerelHematology
city: Tours Cedex
country: France
facility: Hopital Bretonneau
city: Berlin
country: Germany
facility: Charite, Campus Benjamin Franklin, Medizinische Klinik III
city: Essen
country: Germany
facility: Universitaetsklinikum EssenZentrum fuer Innere Medizin
city: Frankfurt (Oder)
country: Germany
facility: Innere Medizin Klinikum Frankfurt Oder GmBH
city: Freiburg
country: Germany
facility: Universitaetsklinikum FreiburgInnere Med.1, Haematologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Koblenz
country: Germany
facility: Praxis fuer Haematologie und Onkologie Koblenz
city: Köln
country: Germany
facility: Klinikum der Universitat zu Koln
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Mannheim
country: Germany
facility: Mannheimer Onkologie Praxis
city: München
country: Germany
facility: Stadtisches Klinikum Munchen GmbH
city: München
country: Germany
facility: TU München - Klinikum rechts der Isar
city: Münster
country: Germany
facility: Facharzte fur Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis
city: Ulm
country: Germany
facility: University Hospital of Ulm
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
city: Gyor
country: Hungary
facility: Petz Aladar Country Hospital
city: Kaposvar
country: Hungary
facility: Kaposi Mor Oktato Korhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar
city: Szeged
country: Hungary
facility: Szegedi TudomanyegyetemII Belgyogyaszati Klinika
city: Tatabanya
country: Hungary
facility: Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza
city: Dublin
country: Ireland
facility: St James's Hospital
city: Limerick
country: Ireland
facility: Midwestern Regional Hospital
city: Afula
country: Israel
facility: Ha'Emek Medical Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Bnei Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Naharia
country: Israel
facility: Western Galilee Hospital
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center Department of Hematology
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Bari
country: Italy
facility: Azienda Ospedaliera Poloclinico di Bari
city: Bari
country: Italy
facility: Istituto dei Tumori Giovanni Paolo II di Bari
city: Brescia
country: Italy
facility: AO Spedali Civili di Brescia
city: Catania
country: Italy
facility: Azienda Ospedaliera Vittorio Emanuele-Ferrarotto
city: Catanzaro
country: Italy
facility: A.O. Pugliese Ciaccio
city: Cosenza
country: Italy
facility: Azienda Ospedaliera Annunziala
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
city: Florence
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria OORR Foggia
city: Genova
country: Italy
facility: Azienda Ospedaliera San Martino
city: Milano
country: Italy
facility: Fondazione Centro San Raffaele del Monte Tabor
city: Milano
country: Italy
facility: Istituto Oncologico Europeo
city: Milan
country: Italy
facility: IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena
city: Naples
country: Italy
facility: Ospedale Cardarelli
city: Naples
country: Italy
facility: Policlinico Universitario Federico II
city: Novara
country: Italy
facility: Universita del Piemonte Orientale
city: Padova
country: Italy
facility: Universita degli Studi di Padova
city: Potenza
country: Italy
facility: Azienda Ospedaliera Ospedale San Carlo
city: Rome
country: Italy
facility: Ospedale Sant'Eugenio
city: Rome
country: Italy
facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
city: Torino
country: Italy
facility: Osp. S.Giovanni Battista Le Molinette
city: Torrette Di Ancona
country: Italy
facility: Ospedale Umberto I
city: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza
city: Aguascalientes
country: Mexico
facility: Instituto Biomedico de Investigacion AC
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Manukau
country: New Zealand
facility: Middlemore Clinical Trials
city: Takapuna
country: New Zealand
facility: North Shore Hospital
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Kraków
country: Poland
facility: Malopolskie Centrum Medyczne S.C.
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
city: Torun
country: Poland
facility: Specjalistyczny Szpital miejski im. Kopernika
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MON
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra
city: Lisbon
country: Portugal
facility: Hospital de Dia de Hematologia
city: Porto
country: Portugal
facility: Instituto Portugues Oncologia do Porto Francisco Gentil EPE
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Bucharest
country: Romania
facility: Spitalul Clinic Coltea
city: Iasi
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu
city: Timisoara
country: Romania
facility: Spitalul Clinic Municipal de Urgenta Timisoara
city: Arkhangelsk
country: Russian Federation
facility: Archangelsk Regional Clinical Hospital
city: Barnaul
country: Russian Federation
facility: City Hospital 8
city: Ekaterinburg
country: Russian Federation
facility: State Healthcare Institution Sverdlovsk regional clinical hospital 1
city: Kazan
country: Russian Federation
facility: GMU Republic clinical hospital
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl
city: Moscow
country: Russian Federation
facility: State Budgetary Institution of the City of Moscow
city: Moscow
country: Russian Federation
facility: NUZ Central Clinical Hospital
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
city: Novosibirsk
country: Russian Federation
facility: MUZ City Clinical Hospital 2
city: Obninsk
country: Russian Federation
facility: Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: St. Petersburg
country: Russian Federation
facility: FGU Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency
city: St. Petersburg
country: Russian Federation
facility: GUS Leningrad Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies
city: St.Petersburg
country: Russian Federation
facility: St. Petersburg Pavlov State Medical Univ
city: Volgograd
country: Russian Federation
facility: GUZ Volgograd Regional Clinical Oncology
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Parktown
country: South Africa
facility: University Witwatersrand Oncology
city: Pretoria
country: South Africa
facility: Pretoria Academic Hospital
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre
city: Pretoria
country: South Africa
facility: Wilgers Oncology CentreWilgrers Hospital
city: Badalona
country: Spain
facility: Hospital Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D hebron
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital La Paz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro-Majadahonda
city: Malaga
country: Spain
facility: Virgen de la Victoria Hospital Malaga
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Messeguer
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: San Sebastian
country: Spain
facility: Hospital Donostia
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Valencia
country: Spain
facility: Hospital Clinico Universitario
city: Lund
country: Sweden
facility: Skane University Hospital
city: Stockholm
country: Sweden
facility: Stockholm South Hospital
city: Stockholm
country: Sweden
facility: Karolinska University
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth General Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
city: Headington
country: United Kingdom
facility: John Radcliffe Hospital
city: Leeds
country: United Kingdom
facility: Saint James University Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: St. Bartholomew's and The Royal London Hospital
city: London
country: United Kingdom
facility: Guy's and St. Thomas' Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: St George's Healthcare NHS Trust
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
city: Swansea
country: United Kingdom
facility: Singleton Hospital, Southwest Wales Cancer Inst
city: West Bromwich
country: United Kingdom
facility: Sandwell Hospital
Study officials:
affiliation: Celgene Corporation
name: Richard Delarue, MD
role: STUDY_DIRECTOR
References:
citation: 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.