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Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial) (ORIGIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00910910
Recruitment Status : Completed
First Posted : June 1, 2009
Results First Posted : December 21, 2016
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.

Condition or disease Intervention/treatment Phase
B-Cell Chronic Lymphocytic Leukemia Drug: Lenalidomide Drug: Chlorambucil Phase 3

Detailed Description:
After notification from the US Food and Drug Administration (FDA) on 12 July 2013, Celgene agreed to discontinue the lenalidomide treatment for all patients due to an imbalance in the number of deaths in patients treated with lenalidomide versus patients treated with chlorambucil. No specific causality for this imbalance has been identified to date. Investigators were instructed to immediately discontinue all participants from experimental lenalidomide treatment and inform their patients accordingly. Participants on the Chlorambucil arm may continue up to 12 months (13 cycles) with the last participant completing in March 2014. All randomized participants will continue to be followed for overall survival and secondary primary malignancies.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Openlabel, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) Versus Chlorambucil as First-Line Therapy for Previously Untreated Elderly Patients With B-Cell Chronic Lymphocytic Leukemia (The Origin Trial)
Actual Study Start Date : October 13, 2009
Actual Primary Completion Date : March 31, 2014
Actual Study Completion Date : May 9, 2018


Arm Intervention/treatment
Experimental: 1 - Lenalidomide
1 - Lenalidomide
Drug: Lenalidomide

For patients with normal renal function (defined as CrCl ≥ 60 mL/min), 5 mg once daily on Days 1 through 28 of the first 28-day cycle, 10 mg once daily on Days 1 through 28 starting at the second cycle, 15 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first.

For patients with moderate renal impairment (defined as CrCl ≥ 30 to < 60 mL/min), 2.5 mg once daily on Days 1 through 28 of the first 28-day cycle, 5 mg once daily on Days 1 through 28 starting at the second cycle, 7.5 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first.

Other Name: Revlimid

Active Comparator: 2- Chlorambucil
2- Chlorambucil
Drug: Chlorambucil
Patients assigned to the chlorambucil arm will receive oral chlorambucil tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
Other Name: Leukeran




Primary Outcome Measures :
  1. Kaplan-Meier Estimate of Progression Free Survival (PFS) [ Time Frame: From first dose of study drug to date of data cut-off of 18 Feb 2013; up to approximately 39 months ]
    Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator's assessment or death due to any cause on study, whichever occurred first. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression

  2. Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off Date of 14 March 2014 [ Time Frame: From randomization to data cut off date of 31 March 2014; median follow up time for all participants was 12.6 months ]
    Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator's assessment or death due to any cause on study, whichever occurred first. Progressive disease included lymphadenopathy, an appearance of any new lesion such as enlarged lymph nodes (> 1.5 cm), splenomegaly, hepatomegaly or other organ infiltrates, an increase by 50% or more in greatest determined diameter of any previous site or an increase by 50% or more in the sum of the product of diameters of multiple nodes. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: From randomization up to data cut-off of 18 Feb 2013; Up to approximately 39 months; maximum duration of exposure for Lenalidomide was 1086 days and 406 days for Chlorambucil ]
    AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen 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 participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death

  2. Number of Participants With Adverse Events With a Later Cut-off Date of 31 March 2014 [ Time Frame: From randomization to the data cut-off date of 31 March 2014; Up to 53 months; maximum duration of exposure for Lenalidomide was 1140 days and 406 days for Chlorambucil ]
    AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen 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 participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death

  3. Percentage of Participants With the Best Overall Response Based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines [ Time Frame: Up to data cut-off date of 18 Feb 2013; approximately 39 months ]

    A best overall response rate is a CR, CRi, nPR or PR and is defined as:

    Complete Remission (CR):

    • No lymphadenopathy
    • No hepatomegaly or splenomegaly
    • Absence of constitutional symptoms
    • Polymorphonuclear leukocytes ≥ 1500/ul
    • No circulating clonal B-lymphocytes
    • Platelets > 100,000/ul
    • Hemoglobin > 11.0 g/dl
    • Normocellular <30% lymphocytes, no B-lymphoid nodules;

    Incomplete Clinical Response (CRi):

    • CR without bone marrow biopsy confirmation.

    Nodular Partial Response (nPR):

    • CR with the presence of residual clonal nodules.

    Partial Response (PR) requires:

    • ≥ 50% decrease in peripheral blood lymphocyte count
    • ≥ 50% reduction in lymphadenopathy
    • ≥ 50% reduction in size of liver and/or spleen
    • 1 or more of the following:
    • Polymorphonuclear leukocytes ≥ 1500/ul
    • Platelets >100,000/ul

  4. Percentage of Participants With a Best Overall Response Based on IWCLL Guidelines With a Later Cut-off Date of 31 March 2014 [ Time Frame: Up to data cut-off of 31 March 2014; approximately 53 months ]

    A best overall response rate is a CR, CRi, nPR or PR and is defined as:

    Complete Remission (CR):

    • No lymphadenopathy
    • No hepatomegaly or splenomegaly
    • Absence of constitutional symptoms
    • Polymorphonuclear leukocytes ≥ 1500/ul
    • No circulating clonal B-lymphocytes
    • Platelets > 100,000/ul
    • Hemoglobin > 11.0 g/dl
    • Normocellular <30% lymphocytes, no B-lymphoid nodules;

    Incomplete Clinical Response (CRi):

    • CR without bone marrow biopsy confirmation.

    Nodular Partial Response:

    • CR with the presence of residual clonal nodules.

    Partial Response requires:

    • ≥ 50% decrease in peripheral blood lymphocyte count
    • ≥ 50% reduction in lymphadenopathy
    • ≥ 50% reduction in size of liver and/or spleen
    • 1 or more of the following:
    • Polymorphonuclear leukocytes ≥ 1500/ul
    • Platelets >100,000/ul

  5. Kaplan-Meier Estimate for Duration of Response [ Time Frame: Up to data cut-off of 18 Feb 2013; up to approximately 39 months ]
    Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) participants who had not progressed at the time of analysis; 2) participants who had withdrawn consent or were lost to follow-up prior to documentation of progression

  6. Kaplan-Meier Estimate for Duration of Response With a Later Cut-off Date of 31 March 2014 [ Time Frame: Up to data cut-off of 31 March 2014; up to approximately 53 months ]
    Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) patients who had not progressed at the time of analysis; 2) patients who had withdrawn consent or were lost to follow-up prior to documentation of progression

  7. Time to Response [ Time Frame: Up to data cut-off of 18 Feb 2013; up to approximately 39 months ]
    Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines

  8. Time to Response for a Later Cut-off Date of 31 March 2014 [ Time Frame: Up to data cut-off of 31 March 2014; up to approximately 53 months ]
    Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines

  9. Kaplan Meier Estimate of Overall Survival [ Time Frame: Up to data cut off of 31 March 2014; median follow-up for all participants was 18.8 months ]
    Overall Survival is defined as the time between randomization and death from any cause.

  10. Kaplan Meier Estimate for Overall Survival at the Final Analysis [ Time Frame: Up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months ]
    Overall Survival is defined as the time between randomization and death from any cause. Overall survival was censored at the last date that the subject was known to be alive for participants who were alive as of the data cutoff date and for participants who were lost to follow-up before death was documented.

  11. Functional Assessment of Cancer Therapy-General to Create the FACT-Leukemia (FACT-Leu) Quality of Life Instrument [ Time Frame: Day 1 and once every 8 weeks ]
    The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease. The FACT-Leu is described as including 27 items that assess 17 physical symptoms (fevers, bleeding, general pain, stomach pain, chills, night sweats, bruising, lymph node swelling, weakness, tiredness, weight loss, appetite, shortness of breath, functional ability, diarrhea, concentration, and mouth sores) and 10 emotional/social concerns (frustration with activity limitation, discouraged by illness, future planning, uncertainty, worry about illness, emotional lability, isolation, infertility concern, family worry, and worry about infections).

  12. Euro Quality of Life Five Dimension (EQ-5D) Questionnaire [ Time Frame: Day 1 and once every 8 weeks ]
    The standardized extended version of EQ-5D was designed for the collection of health state values using a visual analogue scale (VAS) rating scale - a vertical 20 cm visual analogue scale with the end points labeled best imaginable health state at the top and worst imaginable health state at the bottom having numeric values of 100 and 0 respectively. 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.

  13. Number of Participants and Types of Subsequent Anti-cancer Therapies Received Post Treatment [ Time Frame: Up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months ]
    Subsequent anti-cancer therapies administered to participants following the discontinuation of study drug (either Lenalidomide or Chlorambucil)


Other Outcome Measures:
  1. Number of Participants Deaths During the Treatment and Survival Follow-Up Phase [ Time Frame: From the first dose of study drug up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months ]
    The number of study participants deaths during the treatment and follow-up phase



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must sign an informed consent form.
  2. Age ≥ 65 years
  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.
  5. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
  6. Must agree to follow pregnancy precautions as required by the protocol.
  7. Must agree to receive counseling related to teratogenic and other risks of lenalidomide.
  8. Must agree not to donate blood or semen as defined by the protocol

Exclusion Criteria:

  1. Prior treatment for B-cell CLL.
  2. Any medical condition, that would prevent the subject from signing the informed consent form.
  3. Active infections requiring systemic antibiotics.
  4. Systemic infection that has not resolved > 2 months prior to initiating lenalidomide
  5. Pregnant or lactating females.
  6. Participation in any clinical study or having taken any investigational therapy within 28 days.
  7. Known presence of alcohol and/or drug abuse.
  8. Central nervous system (CNS) involvement.
  9. Prior history of malignancies, other than CLL, unless the subject has been free of the disease for ≥3 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)
  10. History of renal failure requiring dialysis.
  11. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection.
  12. Prior therapy with lenalidomide.
  13. Evidence of TLS at screening
  14. Presence of specific hematology and/or chemistry abnormalities
  15. Uncontrolled hyperthyroidism or hypothyroidism
  16. Venous thromboembolism within one year
  17. ≥ Grade-2 neuropathy
  18. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  19. Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910910


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Locations
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United States, California
California Cancer Associates for Research and Excellence cCARE
Escondido, California, United States, 92025
Innovative Clinical Research Institute
Whittier, California, United States, 90603
United States, Connecticut
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
Cancer Center of Central Connecticut
Southington, Connecticut, United States, 06489
United States, Illinois
University Hematology Oncology Inc.
Centralia, Illinois, United States, 62801
North Chicago VA Medical Center
North Chicago, Illinois, United States, 60064
United States, Indiana
Medical Consultants, PC
Muncie, Indiana, United States, 47303
Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services
New Albany, Indiana, United States, 47150
United States, Kentucky
Purchase Cancer Group
Paducah, Kentucky, United States, 42001
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455-0392
United States, Missouri
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Oncology and Hematology Associates, PA
Denville, New Jersey, United States, 07834
The Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Somerset Hematology-Oncology Associates
Somerville, New Jersey, United States, 08876
United States, New York
Roswell Park Cancer Center
Buffalo, New York, United States, 14263
New York Medical College
Valhalla, New York, United States, 10595
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
United States, Pennsylvania
Drexel University, College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, United States, 19464
Berks Hematology-Oncology Associates
West Reading, Pennsylvania, United States, 19611
Geisinger Health System
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
Charleston Hematology Oncology P.A.
Charleston, South Carolina, United States, 29403
South Carolina Cancer Specialists
Hilton Head Island, South Carolina, United States, 29926
United States, Texas
Central Texas Veterans Health Care System
Temple, Texas, United States, 76504
United States, Washington
Swedish Tumor Institute
Seattle, Washington, United States, 98104
Providence St. Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
United States, Wisconsin
Columbia St Marys Cancer Center
Milwaukee, Wisconsin, United States, 53211
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
IMVS
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Western Hospital
Footscray, Victoria, Australia, 3011
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Australia
Flinders Medical Centre
Bedford Park, Australia, 5042
St. Vincent Hospital
Fitzroy, Australia, 3065
Nepean Hospital
Kingswood, NSW, Australia, 2751
Calvary Mater Hospital
Waratah, Australia, 2298
Westmead Hospital Australia
Westmead, Australia, NSW2145
Austria
Universitaetsklinik Innsbruck
Innsbruck, Austria, 6020
Medical University of Vienna Internalmedicine 1, Hematology
Vienna, Austria, 1190
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Hopital Erasme
Brussels, Belgium, 1070
Hopital de Jolimont
Haine-Saint Paul, Belgium, 7100
AZ Groeninge
Kortrijk, Belgium, 8500
UZ Leuven
Leuven, Belgium, 3000
CHU Mont -Godinne
Yvoir, Belgium, 5530
Brazil
Monte Tabor - Hospital Sao Rafael
Salvador, Bahia, Brazil, 41253-190
BIOCANCER - Centro de Pesquisa e Tratamento do Câncer S/A
Belo Horizonte, Minas Gerais, Brazil, 30150-281
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil, 14784-400
Hospital Universitario de Brasilia
Brasílía, Brazil, 70840-050
Hospital Erasto Gaertner
Curitiba, Brazil, 81520-060
Pro Onco Centro de Tratamento Oncologico
Londrina, Brazil, 86050-190
Hospital Israelita Albert Einstein
Morumbi, Brazil, 05651-901
Instituto Estadual Arthur de Siqueira Cavalcanti - HEMORIO
Rio de Janeiro, Brazil, 20211-030
Instituto Nacional de Cancer - INCA
Rio de Janeiro, Brazil, 20230-130
Centro de Estudos e Pesquisas de Hematologia e Oncologia da Faculdade de Medicina do ABC
Santo Andre, Brazil, 09060-650
Instituto de Ensino e Pesquisa Sao Lucas
São Paulo, Brazil, 01236-030
Fundação Antonio Prudente - AC Camargo Câncer center
São Paulo, Brazil, 01509-900
Bulgaria
MHAT Georgi Stranski PlevenHematology Clinic
Pleven, Bulgaria, 5800
University hospital Sveti Georgi Hematology Clinic
Plovdiv, Bulgaria, 4002
Military Medical Academy
Sofia, Bulgaria, 1606
National Specialized Hospital for Active Treatment of Hematology Diseases
Sofia, Bulgaria, 1756
University hospital Sveta Marina
Varna, Bulgaria, 9010
Canada, New Brunswick
Regional Health Authority B-Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
General Hospital, Eastern Health
St John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Quebec
Hospital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V2H1
Sacre-Couer Hospital
Montreal, Quebec, Canada, H4J 1C5
Chile
Instituto Oncologico
Renaca, Chile, 2540364
Instituto Clinico Oncologico del Sur ICOS
Temuco, Chile, 4810469
Colombia
Oncomedica S.A.
Monteria, Colombia
Croatia
University Hospital Centre Split
Split, Croatia, 21000
General Hospital Sveti Duh
Zagreb, Croatia, 10000
Klinicka bolnica Dubrava Klinika za unutarnje bolesti Odjel za Hematologiju
Zagreb, Croatia, 10000
University Hospital Centre Zagreb
Zagreb, Croatia, 10000
Czechia
University Hospital2.Dep.Intern.Med. Hematology
Hradec Kralove, Czechia, 500 05
Fakultni nemocnice Ostrava
Ostrava, Czechia, 70852
Faculty Hospital Kralovske Vinohrady
Prague, Czechia, 100 00
Denmark
Rigshospitalet University Hospital
Copenhagen, Denmark, 2100
Herlev University Hospital Dep of hematology
Harlev, Denmark, 2730
Roskilde University Hospital
Roskilde, Denmark, 4000
France
Bergonie Institut
Bordeaux, France, 33076
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
CHRU
Grenoble cedex 09, France, 38043
CHU Dupuytren
Limoges, France, 87042
Hopital de l'Archet 1
Nice, France, 06200
CHU Hautepierre
Strasbourg, France, 67098
Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, Hungary, 4032
Kaposi Mor Oktato Korhaz
Kaposvar, Hungary, 7400
Szegedi TudomanyegyetemII Belgyogyaszati Klinika
Szeged, Hungary, 6720
Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza
Tatabanya, Hungary
Petz Aladar Country Hospital
Vasvari Pal U. 2, Hungary, 9023
Israel
Ha'Emek Medical Center
Afula, Israel, 18101
Barzilai Medical Center
Ashkelon, Israel, 78278
Soroka University Medical Center
Beer Sheva, Israel, 84101
Bnei Zion Medical Center
Haifa, Israel, 31048
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Meir Medical Center
Kfar-Saba, Israel, 44281
Western Galilee Hospital
Naharia, Israel, 22100
Rabin Medical Center
Petach Tikva, Israel, 49100
Kaplan Medical Center
Rehovot, Israel, 76100
Tel Aviv Sourasky Medical Center Department of Hematology
Tel Aviv, Israel, 64239
Sheba Medical Center
Tel Hashomer, Israel, 52621
Italy
Azienda Ospedaliera Policlinico di Bari
Bari, Italy, 70124
Azienda Ospedaliera Universitaria Careggi
Firenze, Italy, 50134
IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Milan, Italy, 20122
Ospedale San Raffaele S.r.l.
Milan, Italy, 20132
Istituto Europeo di Oncologia - IEO
Milan, Italy, 20141
Azienda Ospedaliero Universitaria di Modena
Modena, Italy, 41100
Ospedale Cardarelli
Naples, Italy, 80131
Universita del Piemonte Orientale
Novara, Italy, 28100
AOU San Luigi Gonzaga
Orbassano, Italy, 10043
Universita degli Studi di Padova
Padova, Italy, 35128
Ospedale S. Chiara
Pisa, Italy, 56126
Azienda Ospedaliera Ospedale San Carlo
Potenza, Italy, 85100
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, Italy, 53100
Ospedale Umberto I
Torrette Di Ancona, Italy, 60020
Netherlands
Maxima Medisch Centrum
Eindhoven, Netherlands, 5631
Spaame Ziekenhuis
Hoofddorp, Netherlands, 2135
Isala Klinieken
Zwolle, Netherlands, 8025 AB
New Zealand
Christchurch Hospital
Christchurch, New Zealand, 8011
North Shore University Hospital
Takapuna, New Zealand, 1309
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
Lodz, Poland, 93-510
Specjalistyczny Szpital miejski im. Kopernika
Torun, Poland, 87-100
Klinika Chorob wewnetrznych i Hematologii
Warszawa, Poland, 00-909
Nowotworww Krwi i Transplantacji Szpiku
Wroclaw, Poland, 50-367
Portugal
Hospitais da Universidade de Coimbra
Coimbra, Portugal, 3000-075
Instituto Portugues Oncologia do Porto Francisco Gentil EPE
Porto, Portugal, 4200-072
Romania
Institutul Clinic Fundeni
Bucharest, Romania, 022328
Spitalul Clinic Coltea
Bucharest, Romania, 030171
Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi
Iasi, Romania, 700111
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, Romania, 550245
Spitalul Clinic Municipal de Urgenta Timisoara
Timisoara, Romania, 300079
Russian Federation
Archangelsk Regional Clinical Hospital
Arkhangelsk, Russian Federation, 163045
City Hospital 8
Barnaul, Russian Federation, 659010
Regional Clinical Hospital 1
Ekaterinburg, Russian Federation, 620102
Russian Academy of Medical Sciences Institution
Moscow, Russian Federation, 115478
Moscow GUZ City Clinical Hospital
Moscow, Russian Federation, 125284
NUZ Central Clinical Hospital
Moscow, Russian Federation, 129128
GUZ Nizhegorodskaya Regional Clinical Hospital
Nizhniy Novgorod, Russian Federation, 603126
MUZ City clinical hospital
Novosibirsk, Russian Federation, 630051
St. Petersburg Research Institute of Hematology and Blood Transfusion
St. Petersburg, Russian Federation, 191024
GUS Leningrad Regional Clinical Hospital
St. Petersburg, Russian Federation, 194291
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
St. Petersburg, Russian Federation, 197341
Serbia
Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Clinical Center Nis
Nis, Serbia, 18000
Slovakia
Narodny onkologicky ustav
Bratislava, Slovakia, 83101
Martinska Fakultna Nemocnica
Martin, Slovakia, 03659
South Africa
University Witwatersrand Oncology
Parktown, South Africa, 2193
Pretoria Academic Hospital
Pretoria, South Africa, 0002
Mary Potter Oncology Centre
Pretoria, South Africa
Spain
Hospital Germans Trias I Pujol
Badalona, Spain, 08916
Hospital Universitario Vall D hebron
Barcelona, Spain, 08035
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Hospital Ramon y Cajal
Madrid, Spain, 28034
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Spain, 28222
Hospital General Universitario Morales Messeguer
Murcia, Spain, 30008
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Donostia
San Sebastian, Spain, 20014
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Hospital Universitario La Fe
Valencia, Spain, 46009
United Kingdom
Royal Bournemouth General Hospital
Bournemouth, United Kingdom, BH7 7DW
St. Bartholomew's and The Royal London Hospital
London, United Kingdom, EC1A 7BE
St George's Healthcare NHS Trust
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Jeffrey Jones, MD Celgene Corporation

Additional Information:
Publications of Results:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00910910     History of Changes
Other Study ID Numbers: CC-5013-CLL-008
2008-003079-32 ( EudraCT Number )
First Posted: June 1, 2009    Key Record Dates
Results First Posted: December 21, 2016
Last Update Posted: July 9, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Lenalidomide
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Chlorambucil
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action