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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00910910




Registration number
NCT00910910
Ethics application status
Date submitted
28/05/2009
Date registered
29/05/2009
Date last updated
14/12/2018

Titles & IDs
Public title
Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)
Scientific 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)
Secondary ID [1] 0 0
2008-003079-32
Secondary ID [2] 0 0
CC-5013-CLL-008
Universal Trial Number (UTN)
Trial acronym
ORIGIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-Cell Chronic Lymphocytic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Chlorambucil

Experimental: 1 - Lenalidomide - 1 - Lenalidomide

Active Comparator: 2- Chlorambucil - 2- Chlorambucil


Treatment: Drugs: 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.

Treatment: Drugs: 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).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off of 31 March 2014 - 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.
Timepoint [1] 0 0
Data cut-off of 31 March 2014; up to approximately 53 months
Primary outcome [2] 0 0
Kaplan-Meier Estimate of Progression Free Survival (PFS) - 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
Timepoint [2] 0 0
Data cut-off of 18 Feb 2013; up to approximately 39 months
Secondary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) - 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
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Number of Participants With Adverse Events (AEs) With a Later Cut-off of 31 March 2014 - 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
Timepoint [2] 0 0
From randomization to the data cut-off of 31 March 2014; Up to 53 months; maximum duration of exposure for Lenalidomide was 1140 days and 406 days for Chlorambucil
Secondary outcome [3] 0 0
Kaplan-Meier Estimate for Duration of Response With a Later Cut-off of 31 March 2014 - 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
Timepoint [3] 0 0
Up to data cut-off of 31 March 2014; up to approximately 53 months
Secondary outcome [4] 0 0
Time to Response for a Later Cut-off of 31 March 2014 - Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines
Timepoint [4] 0 0
Up to data cut-off of 31 March 2014; up to approximately 53 months
Secondary outcome [5] 0 0
Kaplan Meier Estimate for Overall Survival - Overall Survival is defined as the time between randomization and death from any cause..
Timepoint [5] 0 0
Up to data cut off of 18 Feb 2013; up to approximately 39 months;
Secondary outcome [6] 0 0
Kaplan Meier Estimate of Overall Survival for a Later Cut-off of 31 March 2014 - Overall Survival is defined as the time between randomization and death from any cause.
Timepoint [6] 0 0
Up to data cut off of 31 March 2014; up to approximately 53 months; median follow-up was 18.8 months
Secondary outcome [7] 0 0
Functional Assessment of Cancer Therapy-General to Create the FACT-Leukemia (FACT-Leu) Quality of Life Instrument - 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).
Timepoint [7] 0 0
Day 1 and once every 8 weeks
Secondary outcome [8] 0 0
Euro Quality of Life Five Dimension (EQ-5D) Questionnaire - 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.
Timepoint [8] 0 0
Day 1 and once every 8 weeks
Secondary outcome [9] 0 0
Percentage of Participants With the Best Overall Response Based on the International Workshop on Chronic Lymphocytic Leukemia Guidelines (IWCLL) Guidelines - 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
Timepoint [9] 0 0
Up to data cut-off of 18 Feb 2013; approximately 39 months
Secondary outcome [10] 0 0
Percentage of Participants With Overall Response Based on IWCLL Guidelines With a Later Cut-off of 31 March 2014 - 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
Timepoint [10] 0 0
Up to data cut-off of 31 March 2014; approximately 53 months
Secondary outcome [11] 0 0
Kaplan-Meier Estimate for Duration of Response - 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
Timepoint [11] 0 0
Up to data cut-off of 18 Feb 2013; up to approximately 39 months
Secondary outcome [12] 0 0
Time to Response - Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines
Timepoint [12] 0 0
Up to data cut-off of 18 Feb 2013; up to approximately 39 months
Secondary outcome [13] 0 0
Number of Participants With Subsequent Anti-cancer Therapies Received Post Treatment - Subsequent anti-cancer therapies administered to participants following the discontinuation of study drug (either Lenalidomide or Chlorambucil)
Timepoint [13] 0 0
Up to data cut-off of 31 March 2014; up to approximately 53 months

Eligibility
Key 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
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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]

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
IMVS - Adelaide
Recruitment hospital [3] 0 0
Western Hospital - Footscray
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
St. Vincent Hospital - Fitzroy
Recruitment hospital [7] 0 0
Nepean Hospital - Kingswood, NSW
Recruitment hospital [8] 0 0
Calvary Mater Hospital - Waratah
Recruitment hospital [9] 0 0
Westmead Hospital Australia - Westmead
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
3050 - Melbourne
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
2751 - Kingswood, NSW
Recruitment postcode(s) [8] 0 0
2298 - Waratah
Recruitment postcode(s) [9] 0 0
NSW2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Connecticut
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Illinois
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Indiana
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Kentucky
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Minnesota
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United States of America
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Missouri
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Nevada
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New Jersey
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United States of America
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New York
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Pennsylvania
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South Carolina
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Texas
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United States of America
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Washington
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United States of America
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Wisconsin
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Austria
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Innsbruck
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Haine-Saint Paul
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Yvoir
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Bahia
Country [25] 0 0
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Minas Gerais
Country [26] 0 0
Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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Brazil
State/province [28] 0 0
Brasílía
Country [29] 0 0
Brazil
State/province [29] 0 0
Curitiba
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Brazil
State/province [30] 0 0
Londrina
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Brazil
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Morumbi
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Brazil
State/province [32] 0 0
Rio de Janeiro
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Brazil
State/province [33] 0 0
Santo Andre
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Pleven
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Plovdiv
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Sofia
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Bulgaria
State/province [37] 0 0
Varna
Country [38] 0 0
Canada
State/province [38] 0 0
New Brunswick
Country [39] 0 0
Canada
State/province [39] 0 0
Newfoundland and Labrador
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
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Chile
State/province [41] 0 0
Renaca
Country [42] 0 0
Chile
State/province [42] 0 0
Temuco
Country [43] 0 0
Colombia
State/province [43] 0 0
Monteria
Country [44] 0 0
Croatia
State/province [44] 0 0
Split
Country [45] 0 0
Croatia
State/province [45] 0 0
Zagreb
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Czechia
State/province [46] 0 0
Hradec Kralove
Country [47] 0 0
Czechia
State/province [47] 0 0
Ostrava
Country [48] 0 0
Czechia
State/province [48] 0 0
Prague
Country [49] 0 0
Denmark
State/province [49] 0 0
Copenhagen
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Denmark
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Harlev
Country [51] 0 0
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Roskilde
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State/province [52] 0 0
Bordeaux
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France
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Grenoble cedex 09
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Limoges
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Nice
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Debrecen
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Kaposvar
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Szeged
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Tatabanya
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Hungary
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Vasvari Pal U. 2
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Israel
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Afula
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Israel
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Ashkelon
Country [64] 0 0
Israel
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Beer Sheva
Country [65] 0 0
Israel
State/province [65] 0 0
Haifa
Country [66] 0 0
Israel
State/province [66] 0 0
Jerusalem
Country [67] 0 0
Israel
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Kfar-Saba
Country [68] 0 0
Israel
State/province [68] 0 0
Naharia
Country [69] 0 0
Israel
State/province [69] 0 0
Petach Tikva
Country [70] 0 0
Israel
State/province [70] 0 0
Rehovot
Country [71] 0 0
Israel
State/province [71] 0 0
Tel Aviv
Country [72] 0 0
Israel
State/province [72] 0 0
Tel Hashomer
Country [73] 0 0
Italy
State/province [73] 0 0
Bari
Country [74] 0 0
Italy
State/province [74] 0 0
Firenze
Country [75] 0 0
Italy
State/province [75] 0 0
Milan
Country [76] 0 0
Italy
State/province [76] 0 0
Modena
Country [77] 0 0
Italy
State/province [77] 0 0
Naples
Country [78] 0 0
Italy
State/province [78] 0 0
Novara
Country [79] 0 0
Italy
State/province [79] 0 0
Orbassano
Country [80] 0 0
Italy
State/province [80] 0 0
Padova
Country [81] 0 0
Italy
State/province [81] 0 0
Pisa
Country [82] 0 0
Italy
State/province [82] 0 0
Potenza
Country [83] 0 0
Italy
State/province [83] 0 0
Siena
Country [84] 0 0
Italy
State/province [84] 0 0
Torrette Di Ancona
Country [85] 0 0
Netherlands
State/province [85] 0 0
Eindhoven
Country [86] 0 0
Netherlands
State/province [86] 0 0
Hoofddorp
Country [87] 0 0
Netherlands
State/province [87] 0 0
Zwolle
Country [88] 0 0
New Zealand
State/province [88] 0 0
Christchurch
Country [89] 0 0
New Zealand
State/province [89] 0 0
Takapuna
Country [90] 0 0
Poland
State/province [90] 0 0
Gdansk
Country [91] 0 0
Poland
State/province [91] 0 0
Lodz
Country [92] 0 0
Poland
State/province [92] 0 0
Torun
Country [93] 0 0
Poland
State/province [93] 0 0
Warszawa
Country [94] 0 0
Poland
State/province [94] 0 0
Wroclaw
Country [95] 0 0
Portugal
State/province [95] 0 0
Coimbra
Country [96] 0 0
Portugal
State/province [96] 0 0
Porto
Country [97] 0 0
Romania
State/province [97] 0 0
Bucharest
Country [98] 0 0
Romania
State/province [98] 0 0
Iasi
Country [99] 0 0
Romania
State/province [99] 0 0
Sibiu
Country [100] 0 0
Romania
State/province [100] 0 0
Timisoara
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Arkhangelsk
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Barnaul
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Russian Federation
State/province [103] 0 0
Ekaterinburg
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Russian Federation
State/province [104] 0 0
Moscow
Country [105] 0 0
Russian Federation
State/province [105] 0 0
Nizhniy Novgorod
Country [106] 0 0
Russian Federation
State/province [106] 0 0
Novosibirsk
Country [107] 0 0
Russian Federation
State/province [107] 0 0
St. Petersburg
Country [108] 0 0
Serbia
State/province [108] 0 0
Kragujevac
Country [109] 0 0
Serbia
State/province [109] 0 0
Nis
Country [110] 0 0
Slovakia
State/province [110] 0 0
Bratislava
Country [111] 0 0
Slovakia
State/province [111] 0 0
Martin
Country [112] 0 0
South Africa
State/province [112] 0 0
Parktown
Country [113] 0 0
South Africa
State/province [113] 0 0
Pretoria
Country [114] 0 0
Spain
State/province [114] 0 0
Badalona
Country [115] 0 0
Spain
State/province [115] 0 0
Barcelona
Country [116] 0 0
Spain
State/province [116] 0 0
Madrid
Country [117] 0 0
Spain
State/province [117] 0 0
Majadahonda
Country [118] 0 0
Spain
State/province [118] 0 0
Murcia
Country [119] 0 0
Spain
State/province [119] 0 0
Salamanca
Country [120] 0 0
Spain
State/province [120] 0 0
San Sebastian
Country [121] 0 0
Spain
State/province [121] 0 0
Santander
Country [122] 0 0
Spain
State/province [122] 0 0
Valencia
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Bournemouth
Country [124] 0 0
United Kingdom
State/province [124] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00910910
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Jeffrey Jones, MD
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Celgene Corporation
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Contact person for public queries
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Contact person for scientific queries

Summary results
Other publications