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 2014 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00774345
First received: October 16, 2008
Last updated: August 7, 2014
Last verified: August 2014
  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 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: 400
Study Start Date: January 2009
Estimated Study Completion Date: August 2018
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 Terminated
Scottsdale, Arizona, United States, 85259
United States, California
Pacific Coast Hematology Terminated
Fountain Valley, California, United States, 92708
Sharp Memorial Hospital Terminated
San Diego, California, United States, 92123
Kaiser Permanente Medical Group Recruiting
San Diego, California, United States, 92120
Contact: , MD         
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305
Contact: , MD         
United States, Colorado
University of Colorado Terminated
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers Terminated
Denver, Colorado, United States, 80218
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 Recruiting
Brooksville, Florida, United States, 34613
Memorial Hospital Recruiting
Hollywood, Florida, United States, 33021
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Florida Hospital Cancer Institute Waterman Terminated
Tavares, Florida, United States
Lake County Oncology and Hematology Terminated
Tavares, Florida, United States, 32778
Lake County Oncology and Hematology Terminated
The Villages, Florida, United States, 32159
United States, Georgia
Augusta Oncology Associates Terminated
Augusta, Georgia, United States, 30901
Northwest Georgia Oncology Centers, PC Terminated
Marietta, Georgia, United States, 30060
United States, Illinois
Rush University Medical Center Terminated
Chicago, Illinois, United States, 60612
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Edward Hines Jr. VA Hospital Recruiting
Hines, Illinois, United States, 60141
North Chicago VA Medical Center Terminated
North Chicago, Illinois, United States, 60064
Hematology Oncology Assoc. of IL. Terminated
Skokie, Illinois, United States, 60076
United States, Indiana
Cancer Center Inc. Terminated
New Albany, Indiana, United States, 47150
Floyd Memorial Cancer Center of Indiana Terminated
New Albany, Indiana, United States
United States, Iowa
McFarland Clinic Terminated
Ames, Iowa, United States, 50010
Siouxland Hematology-Oncology Associates, LLP Terminated
Sioux City, Iowa, United States, 51101-1733
United States, Louisiana
Ochsner Medical Institutions Recruiting
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Massachusets General Hospital Terminated
Boston, Massachusetts, United States, 02114
United States, Nevada
Nevada Cancer Research Foundation Terminated
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Hackensack University Medical Center Terminated
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute Terminated
Buffalo, New York, United States, 14263
Winthrop University Hospital Oncology Terminated
Mineola, New York, United States, 11501
Long Island Jewish Medical Center Terminated
New Hyde Park, New York, United States, 11042
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13215
New York Medical College Terminated
Valhalla, New York, United States, 10595
United States, North Carolina
Wake Forest University Terminated
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
Oncology Hematology Care Terminated
Cincinnati, Ohio, United States, 45242
The Christ Hospital Terminated
Cincinnati, Ohio, United States, 45219
The Cleveland Clinic Foundation Terminated
Cleveland, Ohio, United States, 44195
Case Western Reserve University Hospitals of Cleveland Active, not recruiting
Cleveland, Ohio, United States, 44106
Hematology Oncology Consultants, Inc. Terminated
Columbus, Ohio, United States, 43235
Gabrail Cancer Center Terminated
Dover, Ohio, United States, 44622
Trilogy Cancer Care Terminated
Wooster, Ohio, United States, 44691
United States, Oregon
Kaiser Permanente Medical Group Terminated
Portland, Oregon, United States, 97227
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Gettysburg Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Drexel University College of Medicine Terminated
Philadelphia, Pennsylvania, United States, 19102
Western Pennsylvania Hospital Terminated
Pittsburgh, Pennsylvania, United States, 15224
Abington Hematology Oncology Associates Recruiting
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Charleston Hematology Oncology Associates Terminated
Charleston, South Carolina, United States, 29403
Liberty Hematology Oncology Active, not recruiting
Columbia, South Carolina, United States, 29203
United States, Tennessee
Sarah Cannon Cancer Center Terminated
Nashville, Tennessee, United States, 37203
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
United States, Washington
Swedish Tumor Institute-Medical Oncology Terminated
Seattle, Washington, United States, 98104
Wenatchee Valley Medical Center Recruiting
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Gundersen Lutheran Clinic, Ltd. Terminated
La Crosse, Wisconsin, United States, 54601
Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia, 2050
Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2751
Royal North Shore Hospital Recruiting
St. Leonards, New South Wales, Australia, 2065
Australia, Queensland
Haematology and Oncology Clinics of Australia Terminated
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
IMVS Recruiting
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre Terminated
Bedford Park, South Australia, Australia, 5042
The Queen Elizabeth Hospital Terminated
Woodville, South Australia, Australia, 5011
Australia
Concord Hospital Recruiting
Concord, Australia, 2139
Peter MacCallum Cancer Centre Terminated
East Melbourne, Australia, 3006
St. Vincent's Hospital Recruiting
Fitzroy, Australia, 3065
Frankston Hospital Recruiting
Frankston, Australia, 3199
The St. George Hospital Recruiting
Kogarah, Australia, 2217
Sir Charles Gairdner Hospital Recruiting
Nedlands, Australia, 6009
Austria
Universitaetsklinik Innsbruck Terminated
Innsbruck, Austria, 6020
Hospital Bamherzige Schwestern Terminated
Linz, Austria, 4010
Medical University of Vienna Terminated
Vienna, Austria, 1190
Belgium
AZ St-Jan Brugge AV Terminated
Brugge, Belgium, 8000
Institut Jules Bordet Terminated
Brussels, Belgium, 1000
Cliniques Universitaires St Luc Terminated
Bruxelles, Belgium, 1200
UZ Gent Recruiting
Gent, Belgium, 9000
Hopital de Jolimont Terminated
Haine-Saint Paul, Belgium, 7100
AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
AZ Groeninge Terminated
Leuven, Belgium, 3000
CHU Mont -Godinne Terminated
Yvoir, Belgium, 5530
Canada, New Brunswick
Atlantic Health Sciences Corporation, Saint John Regional Hospital Recruiting
St. John, New Brunswick, Canada, E2L4L2
Canada, Newfoundland and Labrador
Health Sciences Center Terminated
St. Johns, Newfoundland and Labrador, Canada, A1B3V6
Canada, Nova Scotia
CDHA Centre for Clinical Research Terminated
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Princess Margaret Hospital Active, not recruiting
Toronto, Ontario, Canada, M5G2M9
Canada, Quebec
Hôpital du Sacré-Coeur de Montréal Recruiting
Montreal, Quebec, Canada, H4J 1C5
Royal Victoria Hospital Terminated
Montreal, Quebec, Canada, H3A 1A1
Hopital Maisonneuve Rosemont Recruiting
Montreal, Quebec, Canada, H1T 2M4
Canada
Hopital de L'Enfant-Jesus Recruiting
Quebec, Canada, G1J 1Z4
Colombia
Oncomedica S.A. Terminated
Monteria, Córdoba, Colombia, 230002
Czech Republic
Lekarna fakultni nemocnice V Brne Recruiting
Brno, Czech Republic, 62500
University Hospital Terminated
Hradec Kralove, Czech Republic, 500 05
Oncology Centre J.G. Mendela Recruiting
Novy Jicin, Czech Republic, 74101
Faculty Hospital Plzen Recruiting
Plzen, Czech Republic, 30460
Faculty Hospital Kralovske Vinohrady Terminated
Prague, Czech Republic, 10034
General Faculty Hospital 1 - Internal Clinic Recruiting
Prague, Czech Republic, 12808
Denmark
Rigshospitalet University Hospital Recruiting
Copenhagen, Denmark, 2100
Odense University Hospital Recruiting
Odense, Denmark, DK-5000
Vejle Hospital Terminated
Vejle, Denmark, 7100
France
Hopital Aviecenne Terminated
Bobigny Cedex, France, 93009
Bergonie Institut Terminated
Bordeaux, France, 33076
CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire Terminated
Clermont Ferrand, France, 63000
CHRU Grenoble Service d'Hematologie Hopital A. Michalon Terminated
Grenoble, France, 38043
CHU Hotel Dieu Terminated
Nantes Cedex, France, 44093
Hopital de l'Archet 1 Recruiting
Nice, France, 06200
Pitiè-Salpetriere Hospital Terminated
Paris, France, 75651
CHU Lyon Sud Recruiting
Pierre Benite Cedex, France, 69495
CHU La Miletrie Recruiting
Poitiers, France, 86021
Hopital Robert Debre-CHU de Reims Terminated
Reims, France, 51092
CLCC H Becquerel Hematology Recruiting
Rouen, France, 76038
Hopital Bretonneau Recruiting
Tours Cedex, France, 37044
Germany
Charité, Campus Benjamin Franklin Terminated
Berlin, Germany, 12200
Universitaetsklinikum Essen Recruiting
Essen, Germany, 45122
Innere Medizin Klinikum Frankfurt/Oder GmBH Terminated
Frankfurt, Germany, 15236
University Hospital Freiburg Recruiting
Freiburg, Germany, 79106
Medizinische Hochschule Hannover Terminated
Hannover, Germany, 30625
Practice for Hematology and Oncology Recruiting
Koblenz, Germany, 56068
Universitatetsklinik Koeln Recruiting
Koeln, Germany, 50937
University Hospital Leipzig Hematology Department Terminated
Leipzig, Germany, 04103
Mannheimer Onkologie Praxis Recruiting
Mannheim, Germany, 68161
TU Muenchen - Klinikum rechts der Isar Recruiting
Muenchen, Germany, 81675
Practice for Hematology Terminated
Muenster, Germany, 48149
Stadtisches Klinikum Recruiting
Munich, Germany, 80804
University Hospital Ulm Recruiting
Ulm, Germany, 89081
Hungary
Semmelweis Egyetem Recruiting
Budapest, Hungary, 1083
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Recruiting
Debrecen, Hungary, 4032
Petz Aladar Country Hospital Recruiting
Gyor, Hungary, 9024
Kaposi Mor Oktato Korhaz Recruiting
Kaposvar, Hungary, 7400
Pecsi Tudomanyegyetem Recruiting
Pecs, Hungary, 7624
Szegedi Tudomanyegyetem II Belgyogyaszati Klinika Recruiting
Szeged, Hungary, 6720
Szent Borbala Korhaz Terminated
Tatabanya, Hungary, 2800
Ireland
St James's Hospital Recruiting
Dublin, Ireland
Midwestern Regional Hospital Recruiting
Limerick, Ireland
Israel
Haemek Medical Center Recruiting
Afula, Israel, 18101
Barzilay Medical Center Terminated
Ashkelon, Israel, 78278
Soroka University Terminated
Beer Sheva, Israel
Bnei Zion Medical Center Recruiting
Haifa, Israel, 31048
Rambam Health Center Recruiting
Haifa, Israel, 31096
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Meir Medical Center Recruiting
Kfar-Saba, Israel, 44281
Western Galilee Hospital Recruiting
Naharia, Israel, 22100
Rabin Medical Center- Beilinson Campus Recruiting
Petach-Tikva, Israel, 49100
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Tel Aviv Sourasky Medical Center Terminated
Tel-Aviv, Israel, 64239
Italy
Azienda Ospedaliera Poloclinico di Bari Recruiting
Bari, Italy, 70124
Instuto dei Tumori Giovanni Paolo II 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 Terminated
Catanzaro, Italy, 88100
Azienda Ospedaliera Annunziala Terminated
Cosenza, Italy, 87100
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi Terminated
Ferrara, Italy, 44100
Azienda Ospedaliera Universitaria Careggi Recruiting
Florence, Italy, 50139
Azienda Ospedaliera San Martino Recruiting
Genova, Italy, 16132
IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Terminated
Milan, Italy, 20122
Dipartimento di Oncologia, Fondazione San Raffaele del Monte Tabor I.R.C.C.S Terminated
Milan, Italy, 20132
IEO- Istituto Europeo di Oncologia Recruiting
Milan, Italy, 20141
Azienda Ospedaliero Universitaria di Modena Recruiting
Modena, Italy, 41100
Ospedale Cardarelli Terminated
Naples, Italy, 80131
Azienda Ospedaliera Universitaria Federico II Terminated
Naples, Italy, 80131
Universita del Piemonte Orientale Terminated
Novara, Italy, 28100
Università degli Studi di Padova Recruiting
Padova, Italy, 35128
Azienda Ospedaliera Ospedale San Carlo Recruiting
Potenza, Italy, 85100
Ospedale Sant'Eugenio Terminated
Rome, Italy, 00144
Universita degli Studi di Roma La Sapienza Recruiting
Rome, Italy, 00161
Azienda Ospedaliera Universitaria Senese Policlinico "Le Scotte" Terminated
Siena, Italy, 53100
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I Recruiting
Torrette di Ancona, Italy, 60020
AOU S Giovanni Battista Recruiting
Turin, Italy, 10126
Ospedale San Bortolo Terminated
Vicenza, Italy, 36100
Netherlands
VU Medical Centre Recruiting
Amsterdam, Netherlands, 1081 HV
New Zealand
Middlemore Hospital Recruiting
Manukau, Auckland, New Zealand
North Shore Hospital Recruiting
Takapuna, Aukland, New Zealand
Christchurch Hospital Recruiting
Christchurch, New Zealand
Poland
Apteka Szpitalna - Uniwersyrteckie Centrum Kliniczne Recruiting
Gdansk, Poland, 80-952
Wojewodzki Szpital Specjalistyczny im. M. Kopernika Recruiting
Lodz, Poland, 93-510
Specjalistyczny Szpital miejski im. Kopernika Recruiting
Torun, Poland, 87-100
Centralny Szpital Kliniczny MON Terminated
Warsawa, Poland, 04-141
S.P. Szpital Kliniczny Nr1 Terminated
Wroclaw, Poland, 50-367
Portugal
Hospitais da Universidade de Coimbra Recruiting
Coimbra, Portugal, 3000-075
Centro Hospitalar de Lisboa Terminated
Lisbon, Portugal, 1649-035
Instituto Portugues Oncologia do Porto Francisco Gentil EPE Recruiting
Oporto, Portugal, 4200-072
Romania
Institutul Clinic Fundeni Recruiting
Bucharest, Romania, 22328
Spitalul Clinic Coltea Recruiting
Bucharest, Romania, 30171
Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi Terminated
Iasi, Romania, 700111
Spitalul Clinic Judetean de Urgenta Sibiu Terminated
Sibiu, Romania, 550245
Spitalul Clinic Municipal De Urgenta Timisoara - Clinica Hematologie Terminated
Timisoara, Romania, 300079
Russian Federation
Archangelsk Regional Clinical Hospital Recruiting
Archangelsk, Russian Federation, 163045
Municipal Healthcare Institution City Hospital Recruiting
Barnaul, Russian Federation, 659010
Regional Clinical Hospital 1 Recruiting
Ekaterinburg, Russian Federation, 620102
GMU Republic Clinical Hospital Terminated
Kazan, Russian Federation, 420012
NUZ Central Clinical Hospital Terminated
Moscow, Russian Federation, 129128
GU Russian Oncological Research Center Recruiting
Moscow, Russian Federation, 115447
GUZ Moscow City Clinical Hospital n.a.S.P. Botkin Recruiting
Moscow, Russian Federation, 125284
State Healthcare Institution Nizhegorodskaya Regi Recruiting
Nizhniy Novgorod, Russian Federation, 603126
MUZ City clinical hospital Terminated
Novosibirsk, Russian Federation, 630051
Federal State Medical Radiological Research Center Recruiting
Obinsk, Russian Federation, 249036
Institute of Hematology and Transfusiology of Federal Agency On high-tech medical care of FGU Russian Scientific Research Recruiting
St. Petersburg, Russian Federation, 191024
GUZ Leningradskaya Regional Clinical Hospital Recruiting
St. Petersburg, Russian Federation, 194291
Federal State Institution Recruiting
St.Petersburg, Russian Federation, 197341
State Healthcare Institution - Volgograd Regional Terminated
Volgograd, Russian Federation, 400138
South Africa
University of Witwatersrand Terminated
Johannesburg, Gauteng, South Africa, 2193
Pretoria Academic Hospital-University of Pretoria Terminated
Pretoria, South Africa, 1
Wilgers Oncology Centre Terminated
Pretoria, South Africa
Mary Potter Oncology Centre Terminated
Pretoria, South Africa, 181
Spain
Hospital Germans Trias I Pujol Terminated
Badalona, Spain, 8918
Hospital del Mar Terminated
Barcelona, Spain, 8005
Hospital Universitario Calla D hebron Recruiting
Barcelona, Spain, 8035
Hospital Donostia Recruiting
Donostia, Spain, 20014
Hospital 12 de Octubre Terminated
Madrid, Spain, 28041
Hospital Universitario de la Princesa Recruiting
Madrid, Spain, 28006
Hospital Universitario la Paz Terminated
Madrid, Spain, 28046
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Hospital Universitario Puerta de Hierro-Majadahonda Terminated
Majadahonda, Spain, 28220
Virgen de la Victoria Hospital Malaga Terminated
Malaga, Spain, 29010
Hospital Morales Meseguer Recruiting
Murcia, Spain, 3008
Hospital Clinico de Salamanca Terminated
Salamanca, Spain, 37007
Hospital Universitario Marques de Valdecilla Terminated
Santander, Spain, 39008
Hospital Clinico Universitario Terminated
Valencia, Spain, 46010
Sweden
Kliniska provingar Recruiting
Lund, Sweden, 22185
Karolinska University Recruiting
Stockholm, Sweden, 14186
Stockholm South Hospital Terminated
Stockholm, Sweden, 11883
United Kingdom
Royal Bournemouth General Hospital Recruiting
Bournemouth, United Kingdom, BH7 7DW
Addenbrookes Hospital Recruiting
Cambridge, United Kingdom, CB20QQ
West of Scotland Cancer Center, Gartnavel General Hospital Terminated
Glasgow, United Kingdom, G12 0YN
John Radcliffe Hospital Recruiting
Headington, United Kingdom, OX39DU
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 Terminated
London, United Kingdom, SE1 9RT
Bartholomew's and The Royal Terminated
London, United Kingdom, EC1A 7BE
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
St George's Healthcare NHS Trust Recruiting
London, United Kingdom, SW170QT
Christie Hospital NHS Foundation Trust Terminated
Manchester, United Kingdom, M20 4BX
Royal Hallamshire Hospital Recruiting
Sheffield, United Kingdom, S10 2JF
Singleton Hospital Recruiting
Swansea, United Kingdom, SA28QA
Sandwell Hospital Recruiting
West Bromwich, United Kingdom, B714HJ
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 7, 2014
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, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 16, 2014