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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
First received: October 16, 2008
Last updated: November 3, 2015
Last verified: November 2015
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.

Condition Intervention Phase
B-cell Chronic Lymphocytic Leukemia
Drug: Lenalidomide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 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)

Resource links provided by NLM:

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from randomization to death of any cause

  • 240 Events For Progression Free Survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Progression free survival (PFS) is defined as the time from randomization to disease progression or death due to any cause during or after the treatment period, whichever comes first

Secondary Outcome Measures:
  • The number, type, frequency and severity of adverse events (AEs) [ Time Frame: Up to 8 years; All AEs will be recorded by the Investigator(s) from the time of signing of informed consent ] [ Designated as safety issue: Yes ]
    An adverse event (AE) is any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values (as specified by the criteria below), regardless of etiology. Any medical condition that was present prior to study treatment and that remains unchanged or improved should not be recorded as an AE. If there is a worsening of that medical condition, this should be considered an AE.

  • Tumor Response [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Tumor response is defined as the patient's best response to treatment as defined by the iwCLL guidelines.

  • Duration of Response [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Duration of response is defined as the time from first evaluation of an improved response from the patient's baseline condition until progression of disease.

  • Health Related Quality of Life-Fact Leukemia Survey Version 4.0 [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease.

  • Health Related Quality of Life EQ5-D [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    The standardized extended version of EQ-5D was designed for the collection of health state. The participant is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions

Enrollment: 317
Study Start Date: January 2009
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Revlimid
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

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.


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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774345

  Hide Study Locations
United States, Arizona
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85054
United States, California
Pacific Coast Hematology Oncology
Fountain Valley, California, United States, 92708
Kaiser Permanente Medical Group
San Diego, California, United States, 92120
Sharp Memorial Hospital
San Diego, California, United States, 92123
Stanford University Stanford
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218-1210
United States, Connecticut
Cancer Center of Central Connecticut
Plainville, Connecticut, United States, 06062
United States, Florida
Boca Raton Community Hospital
Boca Raton, Florida, United States, 33486
Pasco Hernando Oncology Associates, PA
Brooksville, Florida, United States, 34613
Memorial Hospital
Hollywood, Florida, United States, 33021
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Florida Cancer Specialist
Tavares, Florida, United States, 32778
Florida Hospital Cancer Institute Waterman
Tavares, Florida, United States, 32778
United States, Georgia
Augusta Oncology Associates, P.C.
Augusta, Georgia, United States, 30901
Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute
Marietta, Georgia, United States, 30060
United States, Illinois
Northwestern University, Division of Hematology/Oncology, Dept. of Medicine
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426-3558
Edward Hines Jr VA Hospital
Hines, Illinois, United States, 60141
North Chicago VA Medical Center
North Chicago, Illinois, United States, 60064
Hematology Oncology Assoc. of IL/Orchard Research LLC
Skokie, Illinois, United States, 60076
United States, Indiana
Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services
New Albany, Indiana, United States, 47150
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101-1733
United States, Louisiana
Ochsner Medical Institutions
New Oleans, Louisiana, United States, 70121
United States, Massachusetts
Clinical Unit for Research Trials in Skin (CURTIS) Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Nevada
Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
The Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Winthrop University Hospital
Mineola, New York, United States, 11501
Biomedical Research Alliance of New York, LLC
New Hyde Park, New York, United States, 11042
SUNY Upstate Medical University Medicine Oncology
Syracuse, New York, United States, 13215
Westchester County Medical Center
Valhalla, New York, United States, 10595
United States, North Carolina
Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Case Western Reserve University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Hematology Oncology Consultants, Inc.
Columbus, Ohio, United States, 43235
Gabrail Cancer Center Research
Dover, Ohio, United States, 44622
Trilogy Cancer Care
Wooster, Ohio, United States, 44691
United States, Oregon
Kaiser Permanente Northwest Oncology/Hematology
Portland, Oregon, United States, 97227
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States, 17325
Drexel University, College of Medicine, Clinical Research Group
Philadelphia, Pennsylvania, United States, 19102
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Abington Hematology Oncology Associates Inc
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Charleston Hematology/Oncology P.A.
Charleston, South Carolina, United States, 29403
M. Francisco Gonzalez, MD, PA
Sumter, South Carolina, United States, 29150
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Gundersen Clinic/Lutheran Hospital
La Crosse, Wisconsin, United States, 54601
Australia, New South Wales
Concord Hospital
Concord, New South Wales, Australia, 2139
Australia, Queensland
Haematology and Oncology Clinics of Australasia
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Adelaide, South Australia, Australia, 5000 SA
Flinders Medical Centre
Bedford Park, Australia, 5042
Royal Prince Alfred Hospital
Camperdown, Australia, 2050
Peter MacCallum Cancer Centre
East Melbourne, Australia, 3006
Frankston Hospital
Farkston, Australia, 3199
St. Vincent Hospital
Fitzroy, Australia, 3065
Nepean Hospital
Kingswood, NSW, Australia, 2751
Clinical Trials Unit The St George Hospital
Kogarah, Australia, 2217
Sir Charles Gairdner Hospital
Nedlands, Australia, 6009
Royal North Shore HospitalDepartment of HematologyLevel 4
St. Leonards, Australia, 2065
The Queen Elizabeth Hospital
Woodville, Australia, 5011
Universitaetsklinik Innsbruck
Innsbruck, Austria, 6020
Hospital Bamherzige Schwestern
Linz, Austria, 4010
Medical University of Vienna Internalmedicine 1, Hematology
Vienna, Austria, 1190
AZ Sint-Jan AV Brugge
Brugge, Belgium, 8000
Institut Jules Bordet
Brussels, Belgium, 1000
Cliniques Universitaires St Luc
Bruxelles, Belgium, 1200
UZ Gent Hematology
Gent, Belgium, 9000
Hopital de Jolimont
Haine-Saint Paul, Belgium, 7100
AZ Groeninge
Kortrijk, Belgium, 8500
UZ Leuven
Leuven, Belgium, 3000
CHU Mont -Godinne
Yvoir, Belgium, 5530
Canada, New Brunswick
Regional Health Authority B-Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
General Hospital, Eastern Health
St John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
CDHA Centre for Clinical Research
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
McGill University
Montreal, Quebec, Canada, H2W 1S6
CIUSSS de l'Est-de-l'Ile-de-Montreal
Montreal/Quebec, Quebec, Canada
Hopital De L'Enfant-Jesus
Quebec, Canada, G1J 1Z4
Oncomedica S.A.
Monteria, Colombia
Czech Republic
Interni hematoonkologicka klinika
Brno, Czech Republic, 625 00
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czech Republic, 500 05
Poliklinika Agel Novy Jicin
Novy Jicin, Czech Republic, 74101
Faculty Hospital Plzen
Plzen, Czech Republic, 30460
Faculty Hospital Kralovske Vinohrady
Prague, Czech Republic, 100 00
General Faculty Hosital1.Internal Clinic
Prague, Czech Republic, 12808
Rigshospitalet University Hospital
Copenhagen, Denmark, 2100
Odense University Hospital
Odense, Denmark, DK-5000
Vejle Hospital
Vejle, Denmark, 7100
Hopital Aviecenne
Bobigny Cedex, France, 93009
Bergonie Institut
Bordeaux, France, 33076
CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire
Clermont Ferrand, France, 63000
CHU Hopital Michallon
Grenoble Cedex 09, France, 38043
Centre Hospitalier Lyon Sud
Lyon, France, 69495
Cetre Hospitalier Hotel-Dieu
Nantes cedex 01, France, 44093
Hopital de l'Archet 1
Nice, France, 06200
Hopital Petie- SalpetriereDepartment d'Hematologie
Paris, France, Cedex 13
CHU La Miletrie
Poitiers, France, 86021
CHU de Reims
Reims cedex, France, 51092
CLCC H BecquerelHematology
Rouen, France, 76038
Hopital Bretonneau
Tours Cedex, France, 37044
Charité, Campus Benjamin Franklin, Medizinische Klinik III
Berlin, Germany, 12203
Universitaetsklinikum EssenZentrum fuer Innere Medizin
Essen, Germany, 45122
Innere Medizin Klinikum Frankfurt/Oder GmBH
Frankfurt (Oder), Germany, 15236
Universitaetsklinikum FreiburgInnere Med.1, Haematologie
Freiburg, Germany, 79106
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Praxis fuer Haematologie und Onkologie Koblenz
Koblenz, Germany, 56068
Klinikum der Universität zu Köln
Köln, Germany, 50937
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Mannheimer Onkologie Praxis
Mannheim, Germany, 68161
Städtisches Klinikum München GmbH
München, Germany, 80804
TU München - Klinikum rechts der Isar
München, Germany, 81675
Fachärzte für Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis
Münster, Germany, 48149
University Hospital of Ulm
Ulm, Germany, 89081
Semmelweis Egyetem
Budapest, Hungary, 1083
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
Debrecen, Hungary, 4032
Petz Aladar Country Hospital
Gyor, Hungary, 9024
Kaposi Mor Oktato Korhaz
Kaposvar, Hungary, 7400
Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar
Pecs, Hungary, 7624
Szegedi TudomanyegyetemII Belgyogyaszati Klinika
Szeged, Hungary, 6720
Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza
Tatabanya, Hungary
St James's Hospital
Dublin, Ireland, 8
Midwestern Regional Hospital
Limerick, Ireland
Ha'Emek Medical Center
Afula, Israel, 18101
Barzilai Medical Center
Ashkelon, Israel, 78278
Soroka University Medical Center
Beer Sheva, Israel, 84101
Bnei Zion Medical Center
Haifa, Israel, 31048
Rambam Health Care Campus
Haifa, Israel, 31096
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Meir Medical Center
Kfar-Saba, Israel, 44281
Western Galilee Hospital
Naharia, Israel, 22100
Rabin Medical Center
Petach Tikva, Israel, 49100
Kaplan Medical Center
Rehovot, Israel, 76100
Tel Aviv Sourasky Medical Center Department of Hematology
Tel Aviv, Israel, 64239
Sheba Medical Center
Tel Hashomer, Israel, 52621
Azienda Ospedaliera Poloclinico di Bari
Bari, Italy, 70124
Istituto dei Tumori Giovanni Paolo II di Bari
Bari, Italy, 70124
AO Spedali Civili di Brescia
Brescia, Italy, 25123
Azienda Ospedaliera Vittorio Emanuele-Ferrarotto
Catania, Italy, 95124
A.O. Pugliese Ciaccio
Catanzaro, Italy, 88100
Azienda Ospedaliera Annunziala
Cosenza, Italy, 87100
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Ferrara, Italy, 44100
Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50139
Azienda Ospedaliero Universitaria OORR Foggia
Foggia, Italy, 71100
Azienda Ospedaliera San Martino
Genova, Italy, 16132
IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Milan, Italy, 20122
Fondazione Centro San Raffaele del Monte Tabor
Milano, Italy, 20132
Istituto Oncologico Europeo
Milano, Italy, 20141
Azienda Ospedaliero Universitaria di Modena
Modena, Italy, 41100
Ospedale Cardarelli
Naples, Italy, 80131
Policlinico Universitario Federico II
Naples, Italy, 80131
Universita del Piemonte Orientale
Novara, Italy, 28100
Università degli Studi di Padova
Padova, Italy, 35128
Azienda Ospedaliera Ospedale San Carlo
Potenza, Italy, 85100
Azienda Policlinico Umberto I, Università "La Sapienza" di Roma
Rome, Italy, 00161
Ospedale Sant'Eugenio
Rome, Italy, 00144
Azienda Ospedaliera Universitaria Senese Policlinico "Le Scotte"
Siena, Italy, 53100
Osp. S.Giovanni Battista Le Molinette
Torino, Italy, 10126
Ospedale Umberto I
Torrette di Ancona, Italy, 60020
Ospedale San Bortolo di Vicenza
Vicenza, Italy, 36100
Instituto Biomedico de Investigacion AC
Aguascalientes, Mexico, 20127
VU University Medical Center
Amsterdam, Netherlands, 1081 HV
New Zealand
Christchurch Hospital
Christchurch, New Zealand
Middlemore Clinical Trials
Manukau, New Zealand, 1640
North Shore Hospital
Takapuna, New Zealand, 1309
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Malopolskie Centrum Medyczne S.C.
Kraków, Poland, 30-510
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, Poland, 93-510
Specjalistyczny Szpital miejski im. Kopernika
Torun, Poland, 87-100
Centralny Szpital Kliniczny MON
Warszawa, Poland, 04-141
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, Poland, 50-367
Hospitais da Universidade de Coimbra
Coimbra, Portugal, 3000 - 075
Hospital de Dia de Hematologia
Lisbon, Portugal, 1649-035
Instituto Portugues Oncologia do Porto Francisco Gentil EPE
Oporto, Portugal, 4200-072
Institutul Clinic Fundeni
Bucharest, Romania, 022328
Spitalul Clinic Coltea
Bucharest, Romania, 030171
Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi
Iasi, Romania, 700111
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, Romania, 550245
Spitalul Clinic Municipal de Urgenta Timisoara
Timisoara, Romania, 300079
Russian Federation
Archangelsk Regional Clinical Hospital
Arkhangelsk, Russian Federation, 163045
City Hospital 8
Barnaul, Russian Federation, 659010
State Healthcare Institution "Sverdlovsk regional clinical hospital #1"
Ekaterinburg, Russian Federation, 620102
GMU Republic clinical hospital
Kazan, Russian Federation, 420012
Krasnoyarsk Regional Clinical Hospital
Krasnoyarsk, Russian Federation, 660022
NUZ Central Clinical Hospital
Moscow, Russian Federation, 129128
Moscow GUZ City Clinical Hospital
Moscow, Russian Federation, 125284
Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl
Moscow, Russian Federation, 115447
Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
Nizhniy Novgorod, Russian Federation, 603126
MUZ City Clinical Hospital #2
Novosibirsk, Russian Federation, 630051
Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so
Obninsk, Russian Federation, 249036
Saratov State Medical University
Saratov, Russian Federation, 410012
Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies
St. Petersburg, Russian Federation, 197341
FGU "Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency
St. Petersburg, Russian Federation, 191024
GUS Leningrad Regional Clinical Hospital
St. Petersburg, Russian Federation, 194291
St. Petersburg Pavlov State Medical Univ
St.Petersburg, Russian Federation, 197022
GUZ Volgograd Regional Clinical Oncology
Volgograd, Russian Federation, 400138
South Africa
Groote Schuur Hospital
Cape Town, South Africa
University Witwatersrand Oncology
Parktown, South Africa, 2193
Mary Potter Oncology Centre
Pretoria, South Africa
Pretoria Academic Hospital
Pretoria, South Africa, 0002
Wilgers Oncology CentreWilgrers Hospital
Pretoria, South Africa
Hospital Germans Trias I Pujol
Badalona, Spain, 08916
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitario Vall D hebron
Barcelona, Spain, 08035
Hospital Donostia
Donostia, Spain, 20014
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital La Paz
Madrid, Spain, 28046
Hospital Ramon y Cajal
Madrid, Spain, 28034
Hospital Universitario de la Princessa
Madrid, Spain, 28006
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Spain, 28222
Virgen de la Victoria Hospital Malaga
Malaga, Spain, 29010
Hospital General Universitario Morales Messeguer
Murcia, Spain, 30008
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Hospital Clinico Universitario
Valencia, Spain, 46010
Skane University Hospital
Lund, Sweden, 221 85
Karolinska University
Stockholm, Sweden, 14186
Stockholm South Hospital
Stockholm, Sweden, 11883
United Kingdom
Royal Bournemouth General Hospital
Bournemouth, United Kingdom, BH7 7DW
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Gartnavel General Hospital
Glasgow Scotland, United Kingdom, G12 0YN
John Radcliffe Hospital
Headington, United Kingdom, OX3 9DU
Saint James University Hospital
Leeds, United Kingdom, LS9 7TF
Royal Liverpool University Hospital
Liverpool, United Kingdom, L78XP
Guy's and St. Thomas' Hospital
London, United Kingdom, SE1 9RT
King's College Hospital
London, United Kingdom, SE5 9RS
St George's Healthcare NHS Trust
London, United Kingdom, SW17 0QT
St. Bartholomew's and The Royal London Hospital
London, United Kingdom, EC1A 7BE
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
Sheffield, United Kingdom, S10 2JF
Singleton Hospital, Southwest Wales Cancer Inst
Swansea, United Kingdom, SA28QA
Sandwell Hospital
West Bromwich, United Kingdom, B71 4HJ
Sponsors and Collaborators
Celgene Corporation
Study Director: Kenichi Takechita, MD Celgene Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00774345     History of Changes
Other Study ID Numbers: CC-5013-CLL-002
Study First Received: October 16, 2008
Last Updated: November 3, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ministry of Health
South Africa: Medicines Control Council
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2015