Back to resultsA 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
Primary Purpose
B-cell Chronic Lymphocytic Leukemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenalidomide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Must understand and voluntarily sign an informed consent form.
- Must be greater than or equal to 18 years at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Must have a documented diagnosis of B-cell CLL (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia [Hallek, 2008]).
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)
- 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.
- 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.
- Must have an ECOG performance status score of less than or equal to 2.
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.
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.
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:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Active infections requiring systemic antibiotics.
- Systemic infection that has not resolved > 2 months prior to initiating lenalidomide treatment in spite of adequate anti-infective therapy
- Autologous or allogeneic bone marrow transplant as second-line therapy.
- Pregnant or lactating females.
- Systemic treatment for B-cell CLL in the interval between completing the last cycle of second-line induction therapy and randomization.
- 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.
- Known presence of alcohol and/or drug abuse.
- 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.
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)
- History of renal failure requiring dialysis.
- Known Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), and/or active Hepatitis C Virus (HCV) infection.
- Prior therapy with lenalidomide.
- Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be enrolled upon correction of electrolyte abnormalities).
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)
- Grade 4 rash due to prior thalidomide treatment
- Uncontrolled hyperthyroidism or hypothyroidism
- Venous thromboembolism within one year
- Greater than or equal to Grade-2 neuropathy
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Disease transformation (active) (ie, Richter's Syndrome, prolymphocytic leukemia)
- Known allergy to allopurinol for subjects assessed with PR following their second-line induction therapy.
- Prisoners.
- More than 2 prior lines of CLL therapy.
Sites / Locations
- Mayo Clinic - Arizona
- Pacific Coast Hematology Oncology
- Kaiser Permanente Medical Group
- Sharp Memorial Hospital
- Stanford University Stanford
- University of Colorado Hospital
- Rocky Mountain Cancer Center
- Cancer Center of Central Connecticut
- Boca Raton Community Hospital
- Pasco Hernando Oncology Associates, PA
- Memorial Hospital
- Mayo Clinic - Jacksonville
- Florida Cancer Specialist
- Florida Hospital Cancer Institute Waterman
- Augusta Oncology Associates, P.C.
- Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute
- Northwestern University, Division of Hematology Oncology, Dept. of Medicine
- Rush University Medical Center
- Ingalls Memorial Hospital
- Edward Hines Jr VA Hospital
- North Chicago VA Medical Center
- Hematology Oncology Assoc. of IL Orchard Research LLC
- Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services
- McFarland Clinic
- Siouxland Hematology-Oncology Associates, LLP
- Ochsner Medical Institutions
- Clinical Unit for Research Trials in Skin CURTIS Massachusetts General Hospital
- Nevada Cancer Research Foundation
- The Cancer Center, Hackensack University Medical Center
- Roswell Park Cancer Institute
- Winthrop University Hospital
- Biomedical Research Alliance of New York, LLC
- SUNY Upstate Medical University Medicine Oncology
- Westchester County Medical Center
- Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center
- Gabrail Cancer Center Research
- The Christ Hospital
- Oncology Hematology Care
- University Hospitals Cleveland Medical Center
- Cleveland Clinic
- Hematology Oncology Consultants, Inc.
- Gabrail Cancer Center Research
- Trilogy Cancer Care
- Kaiser Permanente Northwest Oncology Hematology
- Abington Memorial Hospital
- Gettysburg Cancer Center
- Drexel University, College of Medicine, Clinical Research Group
- Western Pennsylvania Hospital
- Abington Hematology Oncology Associates Inc
- Charleston Hematology Oncology P.A.
- M. Francisco Gonzalez, MD, PA
- Sarah Cannon Cancer Center
- UT Southwestern Medical Center
- Swedish Cancer Institute
- Wenatchee Valley Hospital and Clinics
- Gundersen Clinic Lutheran Hospital
- Concord Hospital
- Haematology and Oncology Clinics of Australasia
- IMVS
- Flinders Medical Centre
- Royal Prince Alfred Hospital
- Peter MacCallum Cancer Centre
- Frankston Hospital
- St. Vincent Hospital
- Nepean Hospital
- Clinical Trials Unit The St George Hospital
- Sir Charles Gairdner Hospital
- Royal North Shore HospitalDepartment of HematologyLevel 4
- The Queen Elizabeth Hospital
- Universitaetsklinik Innsbruck
- Hospital Bamherzige Schwestern
- Medical University of Vienna Internalmedicine 1, Hematology
- AZ Sint-Jan AV Brugge
- Institut Jules Bordet
- Cliniques Universitaires St Luc
- UZ Gent Hematology
- Hopital de Jolimont
- AZ Groeninge
- UZ Leuven
- CHU Mont -Godinne
- Regional Health Authority B-Saint John Regional Hospital
- General Hospital, Eastern Health
- CDHA Centre for Clinical Research
- Princess Margaret Hospital
- CIUSSS de l'Est-de-l'Ile-de-Montreal
- McGill University
- Hopital du Sacre-Coeur de Montreal
- Hopital De L'Enfant-Jesus
- Oncomedica S.A.
- Interni hematoonkologicka klinika
- Fakultni nemocnice Hradec Kralove
- Poliklinika Agel Novy Jicin
- Faculty Hospital Plzen
- Faculty Hospital Kralovske Vinohrady
- General Faculty Hosital1.Internal Clinic
- Rigshospitalet University Hospital
- Odense University Hospital
- Vejle Hospital
- Hopital Aviecenne
- Bergonie Institut
- CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire
- CHU Hopital Michallon
- Centre Hospitalier Lyon Sud
- Cetre Hospitalier Hotel-Dieu
- Hopital de l'Archet 1
- Hopital Petie- SalpetriereDepartment d'Hematologie
- CHU La Miletrie
- CHU de Reims
- CLCC H BecquerelHematology
- Hopital Bretonneau
- Charite, Campus Benjamin Franklin, Medizinische Klinik III
- Universitaetsklinikum EssenZentrum fuer Innere Medizin
- Innere Medizin Klinikum Frankfurt Oder GmBH
- Universitaetsklinikum FreiburgInnere Med.1, Haematologie
- Medizinische Hochschule Hannover
- Praxis fuer Haematologie und Onkologie Koblenz
- Klinikum der Universitat zu Koln
- Universitatsklinikum Leipzig
- Mannheimer Onkologie Praxis
- Stadtisches Klinikum Munchen GmbH
- TU München - Klinikum rechts der Isar
- Facharzte fur Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis
- University Hospital of Ulm
- Semmelweis Egyetem
- Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
- Petz Aladar Country Hospital
- Kaposi Mor Oktato Korhaz
- Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar
- Szegedi TudomanyegyetemII Belgyogyaszati Klinika
- Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza
- St James's Hospital
- Midwestern Regional Hospital
- Ha'Emek Medical Center
- Barzilai Medical Center
- Soroka University Medical Center
- Bnei Zion Medical Center
- Rambam Health Care Campus
- Shaare Zedek Medical Center
- Meir Medical Center
- Western Galilee Hospital
- Rabin Medical Center
- Kaplan Medical Center
- Tel Aviv Sourasky Medical Center Department of Hematology
- Sheba Medical Center
- Azienda Ospedaliera Poloclinico di Bari
- Istituto dei Tumori Giovanni Paolo II di Bari
- AO Spedali Civili di Brescia
- Azienda Ospedaliera Vittorio Emanuele-Ferrarotto
- A.O. Pugliese Ciaccio
- Azienda Ospedaliera Annunziala
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
- Azienda Ospedaliera Universitaria Careggi
- Azienda Ospedaliero Universitaria OORR Foggia
- Azienda Ospedaliera San Martino
- Fondazione Centro San Raffaele del Monte Tabor
- Istituto Oncologico Europeo
- IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
- Azienda Ospedaliero Universitaria di Modena
- Ospedale Cardarelli
- Policlinico Universitario Federico II
- Universita del Piemonte Orientale
- Universita degli Studi di Padova
- Azienda Ospedaliera Ospedale San Carlo
- Ospedale Sant'Eugenio
- Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
- Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
- Osp. S.Giovanni Battista Le Molinette
- Ospedale Umberto I
- Ospedale San Bortolo di Vicenza
- Instituto Biomedico de Investigacion AC
- VU University Medical Center
- Christchurch Hospital
- Middlemore Clinical Trials
- North Shore Hospital
- Uniwersyteckie Centrum Kliniczne
- Malopolskie Centrum Medyczne S.C.
- Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
- Specjalistyczny Szpital miejski im. Kopernika
- Centralny Szpital Kliniczny MON
- Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
- Hospitais da Universidade de Coimbra
- Hospital de Dia de Hematologia
- Instituto Portugues Oncologia do Porto Francisco Gentil EPE
- Institutul Clinic Fundeni
- Spitalul Clinic Coltea
- Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi
- Spitalul Clinic Judetean de Urgenta Sibiu
- Spitalul Clinic Municipal de Urgenta Timisoara
- Archangelsk Regional Clinical Hospital
- City Hospital 8
- State Healthcare Institution Sverdlovsk regional clinical hospital 1
- GMU Republic clinical hospital
- Krasnoyarsk Regional Clinical Hospital
- Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl
- State Budgetary Institution of the City of Moscow
- NUZ Central Clinical Hospital
- Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
- MUZ City Clinical Hospital 2
- Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so
- Saratov State Medical University
- FGU Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency
- GUS Leningrad Regional Clinical Hospital
- Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies
- St. Petersburg Pavlov State Medical Univ
- GUZ Volgograd Regional Clinical Oncology
- Groote Schuur Hospital
- University Witwatersrand Oncology
- Pretoria Academic Hospital
- Mary Potter Oncology Centre
- Wilgers Oncology CentreWilgrers Hospital
- Hospital Germans Trias I Pujol
- Hospital del Mar
- Hospital Universitario Vall D hebron
- Hospital Universitario de la Princesa
- Hospital Ramon y Cajal
- Hospital 12 de Octubre
- Hospital La Paz
- Hospital Universitario Puerta de Hierro-Majadahonda
- Virgen de la Victoria Hospital Malaga
- Hospital General Universitario Morales Messeguer
- Hospital Universitario de Salamanca
- Hospital Donostia
- Hospital Universitario Marques de Valdecilla
- Hospital Clinico Universitario
- Skane University Hospital
- Stockholm South Hospital
- Karolinska University
- Royal Bournemouth General Hospital
- Addenbrookes Hospital
- Gartnavel General Hospital
- John Radcliffe Hospital
- Saint James University Hospital
- Royal Liverpool University Hospital
- St. Bartholomew's and The Royal London Hospital
- Guy's and St. Thomas' Hospital
- King's College Hospital
- St George's Healthcare NHS Trust
- Christie Hospital NHS Foundation Trust
- Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
- Singleton Hospital, Southwest Wales Cancer Inst
- Sandwell Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental: 1
Placebo Comparator: 2
Arm Description
Lenalidomide po qd on days 1-28 of a 28 day cycle
Placebo capsules given orally on days 1-28 of a 28 day cycle
Outcomes
Primary Outcome Measures
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death from any cause. OS will be censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Secondary Outcome Measures
Progression Free Survival 2 (PFS2)
Progression Free Survival (PFS2) assessed by investigator is defined as the time from randomization to the second objective disease progression, or death from any cause, whichever occurs first.
Number of Participants With Adverse Events (AEs)
Number of participants with adverse events (AEs) that measure type, frequency and severity of AEs graded by National Cancer Institute Common Terminology Criteria (NCI CTCAE V 3.0) including any grade adverse events (AEs), Grade 3-4 AEs, AEs related to study drug, grade 3-4 AEs related to study drug.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00774345
Brief Title
A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second-Line Therapy (The Continuum Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 27, 2009 (Actual)
Primary Completion Date
October 27, 2020 (Actual)
Study Completion Date
October 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug.
Detailed Description
This is a phase 3, randomized (computer assigned by chance to treatment arm), study being completed an multiple sites to compare the safety and efficacy (how well a drug works) of lenalidomide maintenance therapy to placebo (dummy capsule that contains no lenalidomide or active substances) maintenance therapy.
Patients are assigned by a computer with a 50/50 chance to receive placebo or lenalidomide study treatment. Study drug will be taken once each day until the patient discontinues the study. Patients will remain on study drug until progression of disease.
Patients will visit their study doctor every 28 days until disease progression to complete safety and efficacy assessments. Quality of life assessments will be completed every other month. If a patient who discontinue study drug prior to disease progression (i.e. due to an adverse reaction to the study drug), they will continue to visit the study doctor each month to complete the efficacy assessments up to progression of disease. Safety assessments may include laboratory blood tests, ECG tests and questions about any medical conditions or side effects experienced during the study. Efficacy assessments may include laboratory blood tests and focused physical exams.
Computed tomography (CT) scans along with blood tests and bone marrow samples will be collected to confirm if a patient has improvement of response while on study.
After disease progression, patients will be contacted every 12 weeks for survival information, next CLL treatments and quality of life questions.
Subjects currently on lenalidomide treatment will discontinue lenalidomide treatment immediately and complete the Treatment Discontinuation assessment. The subjects will then transition to the survival follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Chronic Lymphocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
317 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: 1
Arm Type
Experimental
Arm Description
Lenalidomide po qd on days 1-28 of a 28 day cycle
Arm Title
Placebo Comparator: 2
Arm Type
Placebo Comparator
Arm Description
Placebo capsules given orally on days 1-28 of a 28 day cycle
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
Lenalidomide capsules given orally on days 1-28 of a 28 day cycle
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules given orally on days 1 - 28 of a 28 day cycle
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall Survival (OS) is defined as the time from randomization to death from any cause. OS will be censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Time Frame
Up to approximately 11 years
Secondary Outcome Measure Information:
Title
Progression Free Survival 2 (PFS2)
Description
Progression Free Survival (PFS2) assessed by investigator is defined as the time from randomization to the second objective disease progression, or death from any cause, whichever occurs first.
Time Frame
Up to 6 years
Title
Number of Participants With Adverse Events (AEs)
Description
Number of participants with adverse events (AEs) that measure type, frequency and severity of AEs graded by National Cancer Institute Common Terminology Criteria (NCI CTCAE V 3.0) including any grade adverse events (AEs), Grade 3-4 AEs, AEs related to study drug, grade 3-4 AEs related to study drug.
Time Frame
From first dose to 30 days post last dose (up to 9 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must understand and voluntarily sign an informed consent form.
Must be greater than or equal to 18 years at the time of signing the informed consent form.
Must be able to adhere to the study visit schedule and other protocol requirements.
Must have a documented diagnosis of B-cell CLL (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia [Hallek, 2008]).
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)
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.
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.
Must have an ECOG performance status score of less than or equal to 2.
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.
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.
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:
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
Active infections requiring systemic antibiotics.
Systemic infection that has not resolved > 2 months prior to initiating lenalidomide treatment in spite of adequate anti-infective therapy
Autologous or allogeneic bone marrow transplant as second-line therapy.
Pregnant or lactating females.
Systemic treatment for B-cell CLL in the interval between completing the last cycle of second-line induction therapy and randomization.
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.
Known presence of alcohol and/or drug abuse.
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.
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)
History of renal failure requiring dialysis.
Known Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), and/or active Hepatitis C Virus (HCV) infection.
Prior therapy with lenalidomide.
Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be enrolled upon correction of electrolyte abnormalities).
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)
Grade 4 rash due to prior thalidomide treatment
Uncontrolled hyperthyroidism or hypothyroidism
Venous thromboembolism within one year
Greater than or equal to Grade-2 neuropathy
Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
Disease transformation (active) (ie, Richter's Syndrome, prolymphocytic leukemia)
Known allergy to allopurinol for subjects assessed with PR following their second-line induction therapy.
Prisoners.
More than 2 prior lines of CLL therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Delarue, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic - Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Pacific Coast Hematology Oncology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Kaiser Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Stanford University Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1210
Country
United States
Facility Name
Cancer Center of Central Connecticut
City
Plainville
State/Province
Connecticut
ZIP/Postal Code
06062
Country
United States
Facility Name
Boca Raton Community Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Pasco Hernando Oncology Associates, PA
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Memorial Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Florida Cancer Specialist
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
Florida Hospital Cancer Institute Waterman
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
Augusta Oncology Associates, P.C.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern University, Division of Hematology Oncology, Dept. of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426-3558
Country
United States
Facility Name
Edward Hines Jr VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
North Chicago VA Medical Center
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Hematology Oncology Assoc. of IL Orchard Research LLC
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
McFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
Ochsner Medical Institutions
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Clinical Unit for Research Trials in Skin CURTIS Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
The Cancer Center, Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Biomedical Research Alliance of New York, LLC
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
SUNY Upstate Medical University Medicine Oncology
City
Syracuse
State/Province
New York
ZIP/Postal Code
13215
Country
United States
Facility Name
Westchester County Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hematology Oncology Consultants, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Dover
State/Province
Ohio
ZIP/Postal Code
44622
Country
United States
Facility Name
Trilogy Cancer Care
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Kaiser Permanente Northwest Oncology Hematology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Drexel University, College of Medicine, Clinical Research Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Abington Hematology Oncology Associates Inc
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Charleston Hematology Oncology P.A.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
M. Francisco Gonzalez, MD, PA
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Wenatchee Valley Hospital and Clinics
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Gundersen Clinic Lutheran Hospital
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Concord Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Haematology and Oncology Clinics of Australasia
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
IMVS
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000 SA
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
ZIP/Postal Code
3006
Country
Australia
Facility Name
Frankston Hospital
City
Farkston
ZIP/Postal Code
3199
Country
Australia
Facility Name
St. Vincent Hospital
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood, NSW
ZIP/Postal Code
2751
Country
Australia
Facility Name
Clinical Trials Unit The St George Hospital
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal North Shore HospitalDepartment of HematologyLevel 4
City
St. Leonards
ZIP/Postal Code
2065
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville
ZIP/Postal Code
5011
Country
Australia
Facility Name
Universitaetsklinik Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Hospital Bamherzige Schwestern
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Medical University of Vienna Internalmedicine 1, Hematology
City
Vienna
ZIP/Postal Code
1190
Country
Austria
Facility Name
AZ Sint-Jan AV Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitaires St Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Gent Hematology
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hopital de Jolimont
City
Haine-Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Mont -Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Regional Health Authority B-Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
General Hospital, Eastern Health
City
St John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
CDHA Centre for Clinical Research
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CIUSSS de l'Est-de-l'Ile-de-Montreal
City
Montreal/Quebec
State/Province
Quebec
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Hopital du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Hopital De L'Enfant-Jesus
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Oncomedica S.A.
City
Monteria
Country
Colombia
Facility Name
Interni hematoonkologicka klinika
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Poliklinika Agel Novy Jicin
City
Novy Jicin
ZIP/Postal Code
74101
Country
Czechia
Facility Name
Faculty Hospital Plzen
City
Plzen
ZIP/Postal Code
30460
Country
Czechia
Facility Name
Faculty Hospital Kralovske Vinohrady
City
Prague
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
General Faculty Hosital1.Internal Clinic
City
Prague
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Rigshospitalet University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Hopital Aviecenne
City
Bobigny Cedex
ZIP/Postal Code
93009
Country
France
Facility Name
Bergonie Institut
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CHU Hopital Michallon
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Lyon
ZIP/Postal Code
69495
Country
France
Facility Name
Cetre Hospitalier Hotel-Dieu
City
Nantes cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital de l'Archet 1
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hopital Petie- SalpetriereDepartment d'Hematologie
City
Paris
ZIP/Postal Code
Cedex 13
Country
France
Facility Name
CHU La Miletrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU de Reims
City
Reims cedex
ZIP/Postal Code
51092
Country
France
Facility Name
CLCC H BecquerelHematology
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Hopital Bretonneau
City
Tours Cedex
ZIP/Postal Code
37044
Country
France
Facility Name
Charite, Campus Benjamin Franklin, Medizinische Klinik III
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitaetsklinikum EssenZentrum fuer Innere Medizin
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Innere Medizin Klinikum Frankfurt Oder GmBH
City
Frankfurt (Oder)
ZIP/Postal Code
15236
Country
Germany
Facility Name
Universitaetsklinikum FreiburgInnere Med.1, Haematologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Praxis fuer Haematologie und Onkologie Koblenz
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Klinikum der Universitat zu Koln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Mannheimer Onkologie Praxis
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
Facility Name
Stadtisches Klinikum Munchen GmbH
City
München
ZIP/Postal Code
80804
Country
Germany
Facility Name
TU München - Klinikum rechts der Isar
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Facharzte fur Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
University Hospital of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Country Hospital
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Kaposi Mor Oktato Korhaz
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Szegedi TudomanyegyetemII Belgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza
City
Tatabanya
Country
Hungary
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Midwestern Regional Hospital
City
Limerick
Country
Ireland
Facility Name
Ha'Emek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Bnei Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Western Galilee Hospital
City
Naharia
ZIP/Postal Code
22100
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center Department of Hematology
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Azienda Ospedaliera Poloclinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Istituto dei Tumori Giovanni Paolo II di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
AO Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera Vittorio Emanuele-Ferrarotto
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
A.O. Pugliese Ciaccio
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Azienda Ospedaliera Annunziala
City
Cosenza
ZIP/Postal Code
87100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Florence
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria OORR Foggia
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Azienda Ospedaliera San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione Centro San Raffaele del Monte Tabor
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Oncologico Europeo
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Ospedale Cardarelli
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Policlinico Universitario Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Universita del Piemonte Orientale
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Universita degli Studi di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale San Carlo
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Ospedale Sant'Eugenio
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Osp. S.Giovanni Battista Le Molinette
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale Umberto I
City
Torrette Di Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Ospedale San Bortolo di Vicenza
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Instituto Biomedico de Investigacion AC
City
Aguascalientes
ZIP/Postal Code
20127
Country
Mexico
Facility Name
VU University Medical Center
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Middlemore Clinical Trials
City
Manukau
ZIP/Postal Code
1640
Country
New Zealand
Facility Name
North Shore Hospital
City
Takapuna
ZIP/Postal Code
1309
Country
New Zealand
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Malopolskie Centrum Medyczne S.C.
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Specjalistyczny Szpital miejski im. Kopernika
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centralny Szpital Kliniczny MON
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Hospitais da Universidade de Coimbra
City
Coimbra
ZIP/Postal Code
3000 - 075
Country
Portugal
Facility Name
Hospital de Dia de Hematologia
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Instituto Portugues Oncologia do Porto Francisco Gentil EPE
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Institutul Clinic Fundeni
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Spitalul Clinic Coltea
City
Bucharest
ZIP/Postal Code
030171
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi
City
Iasi
ZIP/Postal Code
700111
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sibiu
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Spitalul Clinic Municipal de Urgenta Timisoara
City
Timisoara
ZIP/Postal Code
300079
Country
Romania
Facility Name
Archangelsk Regional Clinical Hospital
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
City Hospital 8
City
Barnaul
ZIP/Postal Code
659010
Country
Russian Federation
Facility Name
State Healthcare Institution Sverdlovsk regional clinical hospital 1
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
GMU Republic clinical hospital
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Clinical Hospital
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl
City
Moscow
ZIP/Postal Code
115447
Country
Russian Federation
Facility Name
State Budgetary Institution of the City of Moscow
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
NUZ Central Clinical Hospital
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
MUZ City Clinical Hospital 2
City
Novosibirsk
ZIP/Postal Code
630051
Country
Russian Federation
Facility Name
Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Saratov State Medical University
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
FGU Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency
City
St. Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
GUS Leningrad Regional Clinical Hospital
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
St. Petersburg Pavlov State Medical Univ
City
St.Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
GUZ Volgograd Regional Clinical Oncology
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Groote Schuur Hospital
City
Cape Town
Country
South Africa
Facility Name
University Witwatersrand Oncology
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pretoria Academic Hospital
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Mary Potter Oncology Centre
City
Pretoria
Country
South Africa
Facility Name
Wilgers Oncology CentreWilgrers Hospital
City
Pretoria
Country
South Africa
Facility Name
Hospital Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario Vall D hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro-Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Virgen de la Victoria Hospital Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital General Universitario Morales Messeguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Donostia
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Clinico Universitario
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Skane University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Stockholm South Hospital
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
Karolinska University
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Royal Bournemouth General Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Gartnavel General Hospital
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Headington
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Saint James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L78XP
Country
United Kingdom
Facility Name
St. Bartholomew's and The Royal London Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Guy's and St. Thomas' Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
St George's Healthcare NHS Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Christie Hospital NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Singleton Hospital, Southwest Wales Cancer Inst
City
Swansea
ZIP/Postal Code
SA28QA
Country
United Kingdom
Facility Name
Sandwell Hospital
City
West Bromwich
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28958469
Citation
Chanan-Khan AA, Zaritskey A, Egyed M, Vokurka S, Semochkin S, Schuh A, Kassis J, Simpson D, Zhang J, Purse B, Foa R. Lenalidomide maintenance therapy in previously treated chronic lymphocytic leukaemia (CONTINUUM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2017 Nov;4(11):e534-e543. doi: 10.1016/S2352-3026(17)30168-0. Epub 2017 Sep 25.
Results Reference
derived
Learn more about this trial
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
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