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 currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00774345
First received: October 16, 2008
Last updated: August 14, 2015
Last verified: August 2015
  Purpose

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


Estimated Enrollment: 320
Study Start Date: January 2009
Estimated Study Completion Date: August 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.

  Eligibility

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

Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic - Arizona Completed
Phoenix, Arizona, United States, 85054
United States, California
Pacific Coast Hematology Oncology Completed
Fountain Valley, California, United States, 92708
Kaiser Permanente Medical Group Recruiting
San Diego, California, United States, 92120
Sharp Memorial Hospital Completed
San Diego, California, United States, 92123
Stanford University Stanford Recruiting
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Hospital Completed
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Center Completed
Denver, Colorado, United States, 80218-1210
United States, Connecticut
Cancer Center of Central Connecticut Recruiting
Southington, Connecticut, United States, 06489
United States, Florida
Boca Raton Community Hospital Recruiting
Boca Raton, Florida, United States, 33486
Pasco Hernando Oncology Associates, PA Completed
Brooksville, Florida, United States, 34613
Memorial Hospital Completed
Hollywood, Florida, United States, 33021
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Florida Hospital Cancer Institute Waterman Completed
Tavares, Florida, United States, 32778
Florida Cancer Specialist Completed
Tavares, Florida, United States, 32778
United States, Georgia
Augusta Oncology Associates, P.C. Completed
Augusta, Georgia, United States, 30901
Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute Completed
Marietta, Georgia, United States, 30060
United States, Illinois
Northwestern University, Division of Hematology/Oncology, Dept. of Medicine Completed
Chicago, Illinois, United States, 60611
Rush University Medical Center Completed
Chicago, Illinois, United States, 60612
Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426-3558
Edward Hines Jr VA Hospital Recruiting
Hines, Illinois, United States, 60141
North Chicago VA Medical Center Completed
North Chicago, Illinois, United States, 60064
Hematology Oncology Assoc. of IL/Orchard Research LLC Completed
Skokie, Illinois, United States, 60076
United States, Indiana
Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services Completed
New Albany, Indiana, United States, 47150
United States, Iowa
McFarland Clinic Completed
Ames, Iowa, United States, 50010
Siouxland Hematology-Oncology Associates, LLP Completed
Sioux City, Iowa, United States, 51101-1733
United States, Louisiana
Ochsner Medical Institutions Recruiting
New Oleans, Louisiana, United States, 70121
United States, Massachusetts
Clinical Unit for Research Trials in Skin (CURTIS) Massachusetts General Hospital Completed
Boston, Massachusetts, United States, 02114
United States, Nevada
Nevada Cancer Research Foundation Completed
Las Vegas, Nevada, United States, 89106
United States, New Jersey
The Cancer Center, Hackensack University Medical Center Completed
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute Completed
Buffalo, New York, United States, 14263
Winthrop University Hospital Completed
Mineola, New York, United States, 11501
Biomedical Research Alliance of New York, LLC Completed
New Hyde Park, New York, United States, 11042
SUNY Upstate Medical University Medicine Oncology Recruiting
Syracuse, New York, United States, 13215
Westchester County Medical Center Completed
Valhalla, New York, United States, 10595
United States, North Carolina
Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center Completed
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Oncology Hematology Care Completed
Cincinnati, Ohio, United States, 45242
The Christ Hospital Completed
Cincinnati, Ohio, United States, 45219
Case Western Reserve University Hospitals of Cleveland Active, not recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Completed
Cleveland, Ohio, United States, 44195
Hematology Oncology Consultants, Inc. Completed
Columbus, Ohio, United States, 43235
Gabrail Cancer Center Research Completed
Dover, Ohio, United States, 44622
Trilogy Cancer Care Completed
Wooster, Ohio, United States, 44691
United States, Oregon
Kaiser Permanente Northwest Oncology/Hematology Completed
Portland, Oregon, United States, 97227
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Gettysburg Cancer Center Completed
Gettysburg, Pennsylvania, United States, 17325
Drexel University, College of Medicine, Clinical Research Group Completed
Philadelphia, Pennsylvania, United States, 19102
Western Pennsylvania Hospital Completed
Pittsburgh, Pennsylvania, United States, 15224
Abington Hematology Oncology Associates Inc Completed
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Charleston Hematology/Oncology P.A. Completed
Charleston, South Carolina, United States, 29403
M. Francisco Gonzalez, MD, PA Completed
Sumter, South Carolina, United States, 29150
United States, Tennessee
Sarah Cannon Cancer Center Completed
Nashville, Tennessee, United States, 37203
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
United States, Washington
Swedish Cancer Institute Completed
Seattle, Washington, United States, 98104
Wenatchee Valley Hospital & Clinics Recruiting
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Gundersen Clinic/Lutheran Hospital Completed
La Crosse, Wisconsin, United States, 54601
Australia, New South Wales
Concord Hospital Recruiting
Concord, New South Wales, Australia, 2139
Australia, South Australia
IMVS Recruiting
Adelaide, South Australia, Australia, 5000 SA
Australia
Flinders Medical Centre Completed
Bedford Park, Australia, 5042
Royal Prince Alfred Hospital Recruiting
Camperdown, Australia, 2050
Peter MacCallum Cancer Centre Completed
East Melbourne, Australia, 3006
Frankston Hospital Recruiting
Farkston, Australia, 3199
St. Vincent Hospital Recruiting
Fitzroy, Australia, 3065
Nepean Hospital Recruiting
Kingswood, NSW, Australia, 2751
Clinical Trials Unit The St George Hospital Completed
Kogarah, Australia, 2217
Sir Charles Gairdner Hospital Recruiting
Nedlands, Australia, 6009
Haematology and Oncology Clinics of Australasia Completed
South Brisbane, Australia, QLD 4101
Royal North Shore HospitalDepartment of HematologyLevel 4 Recruiting
St. Leonards, Australia, 2065
The Queen Elizabeth Hospital Completed
Woodville, Australia, 5011
Austria
Universitaetsklinik Innsbruck Completed
Innsbruck, Austria, 6020
Hospital Bamherzige Schwestern Completed
Linz, Austria, 4010
Medical University of Vienna Internalmedicine 1, Hematology Completed
Vienna, Austria, 1190
Belgium
AZ Sint-Jan AV Brugge Completed
Brugge, Belgium, 8000
Institut Jules Bordet Completed
Brussels, Belgium, 1000
Cliniques Universitaires St Luc Completed
Bruxelles, Belgium, 1200
UZ Gent Hematology Recruiting
Gent, Belgium, 9000
Hopital de Jolimont Completed
Haine-Saint Paul, Belgium, 7100
AZ Groeninge Completed
Kortrijk, Belgium, 8500
UZ Leuven Completed
Leuven, Belgium, 3000
CHU Mont -Godinne Completed
Yvoir, Belgium, 5530
Canada, New Brunswick
Regional Health Authority B-Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
General Hospital, Eastern Health Completed
St John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
CDHA Centre for Clinical Research Completed
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Princess Margaret Hospital Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital du Sacre-Coeur de Montreal Recruiting
Montreal, Quebec, Canada, H4J 1C5
Hospital Maisonneuve - Rosemont Recruiting
Montreal, Quebec, Canada, H1T 2M4
McGill University Completed
Montreal, Quebec, Canada, H2W 1S6
Canada
Hopital De L'Enfant-Jesus Recruiting
Quebec, Canada, G1J 1Z4
Colombia
Oncomedica S.A. Completed
Monteria, Colombia
Czech Republic
Interni hematoonkologicka klinika Recruiting
Brno, Czech Republic, 625 00
Fakultni nemocnice Hradec Kralove Completed
Hradec Kralove, Czech Republic, 500 05
Poliklinika Agel Novy Jicin Recruiting
Novy Jicin, Czech Republic, 74101
Faculty Hospital Plzen Recruiting
Plzen, Czech Republic, 30460
General Faculty Hosital1.Internal Clinic Recruiting
Prague, Czech Republic, 12808
Faculty Hospital Kralovske Vinohrady Completed
Prague, Czech Republic, 100 00
Denmark
Rigshospitalet University Hospital Recruiting
Copenhagen, Denmark, 2100
Odense University Hospital Completed
Odense, Denmark, DK-5000
Vejle Hospital Completed
Vejle, Denmark, 7100
France
Hopital Aviecenne Completed
Bobigny Cedex, France, 93009
Bergonie Institut Completed
Bordeaux, France, 33076
CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire Completed
Clermont Ferrand, France, 63000
CHU Hopital Michallon Completed
Grenoble Cedex 09, France, 38043
Centre Hospitalier Lyon Sud Recruiting
Lyon, France, 69495
Cetre Hospitalier Hotel-Dieu Completed
Nantes cedex 01, France, 44093
Hopital de l'Archet 1 Recruiting
Nice, France, 06200
Hopital Petie- SalpetriereDepartment d'Hematologie Completed
Paris, France, Cedex 13
CHU La Miletrie Recruiting
Poitiers, France, 86021
CHU de Reims Completed
Reims cedex, France, 51092
CLCC H BecquerelHematology Recruiting
Rouen, France, 76038
Hopital Bretonneau Recruiting
Tours Cedex, France, 37044
Germany
Charité, Campus Benjamin Franklin, Medizinische Klinik III Completed
Berlin, Germany, 12203
Universitaetsklinikum EssenZentrum fuer Innere Medizin Recruiting
Essen, Germany, 45122
Innere Medizin Klinikum Frankfurt/Oder GmBH Completed
Frankfurt (Oder), Germany, 15236
Universitaetsklinikum FreiburgInnere Med.1, Haematologie Recruiting
Freiburg, Germany, 79106
Medizinische Hochschule Hannover Completed
Hannover, Germany, 30625
Praxis fuer Haematologie und Onkologie Koblenz Recruiting
Koblenz, Germany, 56068
Klinikum der Universität zu Köln Recruiting
Köln, Germany, 50937
Universitätsklinikum Leipzig Completed
Leipzig, Germany, 04103
Mannheimer Onkologie Praxis Recruiting
Mannheim, Germany, 68161
Städtisches Klinikum München GmbH Recruiting
München, Germany, 80804
TU München - Klinikum rechts der Isar Recruiting
München, Germany, 81675
Fachärzte für Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis Completed
Münster, Germany, 48149
University Hospital of Ulm Recruiting
Ulm, Germany, 89081
Hungary
Semmelweis Egyetem Recruiting
Budapest, Hungary, 1083
Debreceni Egyetem Orvos- és Egészségtudományi Centrum Active, not recruiting
Debrecen, Hungary, 4032
Petz Aladar Country Hospital Recruiting
Gyor, Hungary, 9024
Kaposi Mor Oktato Korhaz Recruiting
Kaposvar, Hungary, 7400
Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar Recruiting
Pecs, Hungary, 7624
Szegedi TudomanyegyetemII Belgyogyaszati Klinika Recruiting
Szeged, Hungary, 6720
Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza Completed
Tatabanya, Hungary
Ireland
St James's Hospital Recruiting
Dublin, Ireland, 8
Midwestern Regional Hospital Recruiting
Limerick, Ireland
Israel
Ha'Emek Medical Center Recruiting
Afula, Israel, 18101
Barzilai Medical Center Completed
Ashkelon, Israel, 78278
Soroka University Medical Center Completed
Beer Sheva, Israel, 84101
Bnei Zion Medical Center Recruiting
Haifa, Israel, 31048
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Meir Medical Center Recruiting
Kfar-Saba, Israel, 44281
Western Galilee Hospital Active, not recruiting
Naharia, Israel, 22100
Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Tel Aviv Sourasky Medical Center Department of Hematology Completed
Tel Aviv, Israel, 64239
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Italy
Azienda Ospedaliera Poloclinico di Bari Recruiting
Bari, Italy, 70124
Istituto dei Tumori Giovanni Paolo II di Bari Recruiting
Bari, Italy, 70124
AO Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
Azienda Ospedaliera Vittorio Emanuele-Ferrarotto Recruiting
Catania, Italy, 95124
A.O. Pugliese Ciaccio Completed
Catanzaro, Italy, 88100
Azienda Ospedaliera Annunziala Completed
Cosenza, Italy, 87100
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi Completed
Ferrara, Italy, 44100
Azienda Ospedaliera Universitaria Careggi Recruiting
Florence, Italy, 50139
Azienda Ospedaliero Universitaria OORR Foggia Recruiting
Foggia, Italy, 71100
Azienda Ospedaliera San Martino Recruiting
Genova, Italy, 16132
IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Completed
Milan, Italy, 20122
Istituto Oncologico Europeo Recruiting
Milano, Italy, 20141
Fondazione Centro San Raffaele del Monte Tabor Completed
Milano, Italy, 20132
Azienda Ospedaliero Universitaria di Modena Recruiting
Modena, Italy, 41100
Ospedale Cardarelli Completed
Naples, Italy, 80131
Policlinico Universitario Federico II Completed
Naples, Italy, 80131
Universita del Piemonte Orientale Completed
Novara, Italy, 28100
Università degli Studi di Padova Recruiting
Padova, Italy, 35128
Azienda Ospedaliera Ospedale San Carlo Recruiting
Potenza, Italy, 85100
Azienda Policlinico Umberto I, Università "La Sapienza" di Roma Recruiting
Rome, Italy, 00161
Ospedale Sant'Eugenio Completed
Rome, Italy, 00144
Azienda Ospedaliera Universitaria Senese Policlinico "Le Scotte" Completed
Siena, Italy, 53100
Osp. S.Giovanni Battista Le Molinette Recruiting
Torino, Italy, 10126
Ospedale Umberto I Recruiting
Torrette di Ancona, Italy, 60020
Ospedale San Bortolo di Vicenza Completed
Vicenza, Italy, 36100
Mexico
Instituto Biomedico de Investigacion AC Completed
Aguascalientes, Mexico, 20127
Netherlands
VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081 HV
New Zealand
Christchurch Hospital Recruiting
Christchurch, New Zealand
Middlemore Clinical Trials Recruiting
Manukau, New Zealand, 1640
North Shore Hospital Recruiting
Takapuna, New Zealand, 1309
Poland
Uniwersyteckie Centrum Kliniczne Recruiting
Gdansk, Poland, 80-952
Malopolskie Centrum Medyczne S.C. Recruiting
Kraków, Poland, 30-510
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Recruiting
Lodz, Poland, 93-510
Specjalistyczny Szpital miejski im. Kopernika Completed
Torun, Poland, 87-100
Centralny Szpital Kliniczny MON Completed
Warszawa, Poland, 04-141
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu Completed
Wroclaw, Poland, 50-367
Portugal
Hospitais da Universidade de Coimbra Recruiting
Coimbra, Portugal, 3000 - 075
Hospital de Dia de Hematologia Completed
Lisbon, Portugal, 1649-035
Instituto Portugues Oncologia do Porto Francisco Gentil EPE Recruiting
Oporto, Portugal, 4200-072
Romania
Institutul Clinic Fundeni Recruiting
Bucharest, Romania, 022328
Spitalul Clinic Coltea Recruiting
Bucharest, Romania, 030171
Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi Completed
Iasi, Romania, 700111
Spitalul Clinic Judetean de Urgenta Sibiu Completed
Sibiu, Romania, 550245
Spitalul Clinic Municipal de Urgenta Timisoara Completed
Timisoara, Romania, 300079
Russian Federation
Archangelsk Regional Clinical Hospital Recruiting
Arkhangelsk, Russian Federation, 163045
City Hospital 8 Recruiting
Barnaul, Russian Federation, 659010
State Healthcare Institution "Sverdlovsk regional clinical hospital #1" Recruiting
Ekaterinburg, Russian Federation, 620102
GMU Republic clinical hospital Completed
Kazan, Russian Federation, 420012
Krasnoyarsk Regional Clinical Hospital Recruiting
Krasnoyarsk, Russian Federation, 660022
Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl Recruiting
Moscow, Russian Federation, 115447
Moscow GUZ City Clinical Hospital Recruiting
Moscow, Russian Federation, 125284
NUZ Central Clinical Hospital Completed
Moscow, Russian Federation, 129128
Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko Recruiting
Nizhniy Novgorod, Russian Federation, 603126
MUZ City Clinical Hospital #2 Completed
Novosibirsk, Russian Federation, 630051
Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so Recruiting
Obninsk, Russian Federation, 249036
Saratov State Medical University Recruiting
Saratov, Russian Federation, 410012
Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies Recruiting
St. Petersburg, Russian Federation, 197341
FGU "Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency Recruiting
St. Petersburg, Russian Federation, 191024
GUS Leningrad Regional Clinical Hospital Recruiting
St. Petersburg, Russian Federation, 194291
St. Petersburg Pavlov State Medical Univ Recruiting
St.Petersburg, Russian Federation, 197022
GUZ Volgograd Regional Clinical Oncology Completed
Volgograd, Russian Federation, 400138
South Africa
Groote Schuur Hospital Completed
Cape Town, South Africa
University Witwatersrand Oncology Completed
Parktown, South Africa, 2193
Mary Potter Oncology Centre Completed
Pretoria, South Africa
Pretoria Academic Hospital Completed
Pretoria, South Africa, 0002
Wilgers Oncology CentreWilgrers Hospital Completed
Pretoria, South Africa
Spain
Hospital Germans Trias I Pujol Completed
Badalona, Spain, 08916
Hospital del Mar Completed
Barcelona, Spain, 08003
Hospital Universitario Vall D hebron Recruiting
Barcelona, Spain, 08035
Hospital Donostia Recruiting
Donostia, Spain, 20014
Hospital 12 de Octubre Completed
Madrid, Spain, 28041
Hospital La Paz Completed
Madrid, Spain, 28046
Hospital Ramon y Cajal Recruiting
Madrid, Spain, 28034
Hospital Universitario de la Princessa Recruiting
Madrid, Spain, 28006
Hospital Universitario Puerta de Hierro-Majadahonda Completed
Majadahonda, Spain, 28222
Virgen de la Victoria Hospital Malaga Completed
Malaga, Spain, 29010
Hospital General Universitario Morales Messeguer Recruiting
Murcia, Spain, 30008
Hospital Universitario de Salamanca Completed
Salamanca, Spain, 37007
Hospital Universitario Marques de Valdecilla Completed
Santander, Spain, 39008
Hospital Clinico Universitario Completed
Valencia, Spain, 46010
Sweden
Skane University Hospital Recruiting
Lund, Sweden, 221 85
Karolinska University Recruiting
Stockholm, Sweden, 14186
Stockholm South Hospital Completed
Stockholm, Sweden, 11883
United Kingdom
Royal Bournemouth General Hospital Recruiting
Bournemouth, United Kingdom, BH7 7DW
Addenbrookes Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Gartnavel General Hospital Completed
Glasgow Scotland, United Kingdom, G12 0YN
John Radcliffe Hospital Recruiting
Headington, United Kingdom, OX3 9DU
St. James University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom, L78XP
Guy's and St. Thomas' Hospital Completed
London, United Kingdom, SE1 9RT
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
St George's Healthcare NHS Trust Recruiting
London, United Kingdom, SW17 0QT
St. Bartholomew's and The Royal London Hospital Completed
London, United Kingdom, EC1A 7BE
Christie Hospital NHS Foundation Trust Completed
Manchester, United Kingdom, M20 4BX
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust Completed
Sheffield, United Kingdom, S10 2JF
Singleton Hospital, Southwest Wales Cancer Inst Recruiting
Swansea, United Kingdom, SA28QA
Sandwell Hospital Recruiting
West Bromwich, United Kingdom, B71 4HJ
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Oliver Kong, 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: August 14, 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
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
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 August 26, 2015