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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)

Primary Purpose

B-Cell Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenalidomide
Chlorambucil
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-Cell Chronic Lymphocytic Leukemia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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]

Sites / Locations

  • California Cancer Associates for Research and Excellence cCARE
  • Innovative Clinical Research Institute
  • The Hospital of Central Connecticut
  • Cancer Center of Central Connecticut
  • University Hematology Oncology Inc.
  • North Chicago VA Medical Center
  • Medical Consultants, PC
  • Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services
  • Purchase Cancer Group
  • University of Minnesota
  • Saint Louis University Cancer Center
  • Nevada Cancer Research Foundation
  • Oncology and Hematology Associates, PA
  • The Cancer Center, Hackensack University Medical Center
  • Somerset Hematology-Oncology Associates
  • Roswell Park Cancer Center
  • New York Medical College
  • Gabrail Cancer Center Research
  • Drexel University, College of Medicine
  • Pottstown Memorial Medical Center
  • Berks Hematology-Oncology Associates
  • Geisinger Health System
  • Charleston Hematology Oncology P.A.
  • South Carolina Cancer Specialists
  • Central Texas Veterans Health Care System
  • Swedish Tumor Institute
  • Providence St. Mary Regional Cancer Center
  • Columbia St Marys Cancer Center
  • Princess Alexandra Hospital
  • IMVS
  • Western Hospital
  • Royal Melbourne Hospital
  • Flinders Medical Centre
  • St. Vincent Hospital
  • Nepean Hospital
  • Calvary Mater Hospital
  • Westmead Hospital Australia
  • Universitaetsklinik Innsbruck
  • Medical University of Vienna Internalmedicine 1, Hematology
  • Institut Jules Bordet
  • Hopital Erasme
  • Hopital de Jolimont
  • AZ Groeninge
  • UZ Leuven
  • CHU Mont -Godinne
  • Monte Tabor - Hospital Sao Rafael
  • BIOCANCER - Centro de Pesquisa e Tratamento do Câncer S/A
  • Hospital de Clínicas de Porto Alegre
  • Hospital Nossa Senhora da Conceicao
  • Fundacao Pio XII - Hospital de Cancer de Barretos
  • Hospital Universitario de Brasilia
  • Hospital Erasto Gaertner
  • Pro Onco Centro de Tratamento Oncologico
  • Hospital Israelita Albert Einstein
  • Instituto Estadual Arthur de Siqueira Cavalcanti - HEMORIO
  • Instituto Nacional de Cancer - INCA
  • Centro de Estudos e Pesquisas de Hematologia e Oncologia da Faculdade de Medicina do ABC
  • Instituto de Ensino e Pesquisa Sao Lucas
  • Fundação Antonio Prudente - AC Camargo Câncer center
  • MHAT Georgi Stranski PlevenHematology Clinic
  • University hospital Sveti Georgi Hematology Clinic
  • Military Medical Academy
  • National Specialized Hospital for Active Treatment of Hematology Diseases
  • University hospital Sveta Marina
  • Regional Health Authority B-Saint John Regional Hospital
  • General Hospital, Eastern Health
  • Hospital Charles LeMoyne
  • Sacre-Couer Hospital
  • Instituto Oncologico
  • Instituto Clinico Oncologico del Sur ICOS
  • Oncomedica S.A.
  • University Hospital Centre Split
  • General Hospital Sveti Duh
  • Klinicka bolnica Dubrava Klinika za unutarnje bolesti Odjel za Hematologiju
  • University Hospital Centre Zagreb
  • University Hospital2.Dep.Intern.Med. Hematology
  • Fakultni nemocnice Ostrava
  • Faculty Hospital Kralovske Vinohrady
  • Rigshospitalet University Hospital
  • Herlev University Hospital Dep of hematology
  • Roskilde University Hospital
  • Bergonie Institut
  • Polyclinique Bordeaux Nord Aquitaine
  • CHRU
  • CHU Dupuytren
  • Hopital de l'Archet 1
  • CHU Hautepierre
  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
  • Kaposi Mor Oktato Korhaz
  • Szegedi TudomanyegyetemII Belgyogyaszati Klinika
  • Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza
  • Petz Aladar Country Hospital
  • Ha'Emek Medical Center
  • Barzilai Medical Center
  • Soroka University Medical Center
  • Bnei Zion Medical Center
  • 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 Policlinico di Bari
  • Azienda Ospedaliera Universitaria Careggi
  • IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
  • Ospedale San Raffaele S.r.l.
  • Istituto Europeo di Oncologia - IEO
  • Azienda Ospedaliero Universitaria di Modena
  • Ospedale Cardarelli
  • Universita del Piemonte Orientale
  • AOU San Luigi Gonzaga
  • Universita degli Studi di Padova
  • Ospedale S. Chiara
  • Azienda Ospedaliera Ospedale San Carlo
  • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
  • Ospedale Umberto I
  • Maxima Medisch Centrum
  • Spaame Ziekenhuis
  • Isala Klinieken
  • Christchurch Hospital
  • North Shore University Hospital
  • Uniwersyteckie Centrum Kliniczne
  • Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
  • Specjalistyczny Szpital miejski im. Kopernika
  • Klinika Chorob wewnetrznych i Hematologii
  • Nowotworww Krwi i Transplantacji Szpiku
  • Hospitais da Universidade de Coimbra
  • 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
  • Regional Clinical Hospital 1
  • Russian Academy of Medical Sciences Institution
  • Moscow GUZ City Clinical Hospital
  • NUZ Central Clinical Hospital
  • GUZ Nizhegorodskaya Regional Clinical Hospital
  • MUZ City clinical hospital
  • St. Petersburg Research Institute of Hematology and Blood Transfusion
  • GUS Leningrad Regional Clinical Hospital
  • Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
  • Clinical Center Kragujevac
  • Clinical Center Nis
  • Narodny onkologicky ustav
  • Martinska Fakultna Nemocnica
  • University Witwatersrand Oncology
  • Pretoria Academic Hospital
  • Mary Potter Oncology Centre
  • Hospital Germans Trias I Pujol
  • Hospital Universitario Vall D hebron
  • Hospital Universitario de la Princesa
  • Hospital Ramon y Cajal
  • Hospital Universitario Puerta de Hierro-Majadahonda
  • Hospital General Universitario Morales Messeguer
  • Hospital Universitario de Salamanca
  • Hospital Donostia
  • Hospital Universitario Marques de Valdecilla
  • Hospital Universitario La Fe
  • Royal Bournemouth General Hospital
  • St. Bartholomew's and The Royal London Hospital
  • St George's Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 - Lenalidomide

2- Chlorambucil

Arm Description

1 - Lenalidomide

2- Chlorambucil

Outcomes

Primary Outcome Measures

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
Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off Date of 14 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.

Secondary Outcome Measures

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
Number of Participants With Adverse Events With a Later Cut-off Date 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
Percentage of Participants With the Best Overall Response Based on the International Workshop on Chronic Lymphocytic Leukemia (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
Percentage of Participants With a Best Overall Response Based on IWCLL Guidelines With a Later Cut-off Date 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
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) 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
Kaplan-Meier Estimate for Duration of Response With a Later Cut-off Date 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
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
Time to Response for a Later Cut-off Date 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
Kaplan Meier Estimate of Overall Survival
Overall Survival is defined as the time between randomization and death from any cause.
Kaplan Meier Estimate for Overall Survival at the Final Analysis
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.
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).
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.
Number of Participants and Types of Subsequent Anti-cancer Therapies Received Post Treatment
Subsequent anti-cancer therapies administered to participants following the discontinuation of study drug (either Lenalidomide or Chlorambucil)

Full Information

First Posted
May 28, 2009
Last Updated
June 14, 2019
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT00910910
Brief Title
Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)
Acronym
ORIGIN
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 13, 2009 (Actual)
Primary Completion Date
March 31, 2014 (Actual)
Study Completion Date
May 9, 2018 (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 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.
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.

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
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - Lenalidomide
Arm Type
Experimental
Arm Description
1 - Lenalidomide
Arm Title
2- Chlorambucil
Arm Type
Active Comparator
Arm Description
2- Chlorambucil
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Chlorambucil
Other Intervention Name(s)
Leukeran
Intervention Description
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).
Primary Outcome Measure Information:
Title
Kaplan-Meier Estimate of Progression Free Survival (PFS)
Description
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
Time Frame
From first dose of study drug to date of data cut-off of 18 Feb 2013; up to approximately 39 months
Title
Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off Date of 14 March 2014
Description
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.
Time Frame
From randomization to data cut off date of 31 March 2014; median follow up time for all participants was 12.6 months
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
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
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
Title
Number of Participants With Adverse Events With a Later Cut-off Date of 31 March 2014
Description
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
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
Title
Percentage of Participants With the Best Overall Response Based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines
Description
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
Time Frame
Up to data cut-off date of 18 Feb 2013; approximately 39 months
Title
Percentage of Participants With a Best Overall Response Based on IWCLL Guidelines With a Later Cut-off Date of 31 March 2014
Description
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
Time Frame
Up to data cut-off of 31 March 2014; approximately 53 months
Title
Kaplan-Meier Estimate for Duration of Response
Description
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
Time Frame
Up to data cut-off of 18 Feb 2013; up to approximately 39 months
Title
Kaplan-Meier Estimate for Duration of Response With a Later Cut-off Date of 31 March 2014
Description
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
Time Frame
Up to data cut-off of 31 March 2014; up to approximately 53 months
Title
Time to Response
Description
Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines
Time Frame
Up to data cut-off of 18 Feb 2013; up to approximately 39 months
Title
Time to Response for a Later Cut-off Date of 31 March 2014
Description
Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines
Time Frame
Up to data cut-off of 31 March 2014; up to approximately 53 months
Title
Kaplan Meier Estimate of Overall Survival
Description
Overall Survival is defined as the time between randomization and death from any cause.
Time Frame
Up to data cut off of 31 March 2014; median follow-up for all participants was 18.8 months
Title
Kaplan Meier Estimate for Overall Survival at the Final Analysis
Description
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.
Time Frame
Up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months
Title
Functional Assessment of Cancer Therapy-General to Create the FACT-Leukemia (FACT-Leu) Quality of Life Instrument
Description
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).
Time Frame
Day 1 and once every 8 weeks
Title
Euro Quality of Life Five Dimension (EQ-5D) Questionnaire
Description
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.
Time Frame
Day 1 and once every 8 weeks
Title
Number of Participants and Types of Subsequent Anti-cancer Therapies Received Post Treatment
Description
Subsequent anti-cancer therapies administered to participants following the discontinuation of study drug (either Lenalidomide or Chlorambucil)
Time Frame
Up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months
Other Pre-specified Outcome Measures:
Title
Number of Participants Deaths During the Treatment and Survival Follow-Up Phase
Description
The number of study participants deaths during the treatment and 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must sign an informed consent form. Age ≥ 65 years Must be able to adhere to the study visit schedule and other protocol requirements. Must have a documented diagnosis of B-cell CLL. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2. Must agree to follow pregnancy precautions as required by the protocol. Must agree to receive counseling related to teratogenic and other risks of lenalidomide. Must agree not to donate blood or semen as defined by the protocol Exclusion Criteria: Prior treatment for B-cell CLL. Any medical condition, that would prevent the subject from signing the informed consent form. Active infections requiring systemic antibiotics. Systemic infection that has not resolved > 2 months prior to initiating lenalidomide Pregnant or lactating females. Participation in any clinical study or having taken any investigational therapy within 28 days. Known presence of alcohol and/or drug abuse. Central nervous system (CNS) involvement. 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) History of renal failure requiring dialysis. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection. Prior therapy with lenalidomide. Evidence of TLS at screening Presence of specific hematology and/or chemistry abnormalities Uncontrolled hyperthyroidism or hypothyroidism Venous thromboembolism within one year ≥ Grade-2 neuropathy Uncontrolled autoimmune hemolytic anemia or thrombocytopenia Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Jones, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
California Cancer Associates for Research and Excellence cCARE
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
The Hospital of Central Connecticut
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Cancer Center of Central Connecticut
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
Facility Name
University Hematology Oncology Inc.
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
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
Medical Consultants, PC
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
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
Purchase Cancer Group
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455-0392
Country
United States
Facility Name
Saint Louis University Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Oncology and Hematology Associates, PA
City
Denville
State/Province
New Jersey
ZIP/Postal Code
07834
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
Somerset Hematology-Oncology Associates
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Roswell Park Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Drexel University, College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Pottstown Memorial Medical Center
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
Berks Hematology-Oncology Associates
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Geisinger Health System
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
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
South Carolina Cancer Specialists
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
Facility Name
Central Texas Veterans Health Care System
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
Facility Name
Swedish Tumor Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Providence St. Mary Regional Cancer Center
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Columbia St Marys Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
IMVS
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
ZIP/Postal Code
5042
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
Calvary Mater Hospital
City
Waratah
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital Australia
City
Westmead
ZIP/Postal Code
NSW2145
Country
Australia
Facility Name
Universitaetsklinik Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Medical University of Vienna Internalmedicine 1, Hematology
City
Vienna
ZIP/Postal Code
1190
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hopital Erasme
City
Brussels
ZIP/Postal Code
1070
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
Monte Tabor - Hospital Sao Rafael
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
BIOCANCER - Centro de Pesquisa e Tratamento do Câncer S/A
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-281
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital Universitario de Brasilia
City
Brasílía
ZIP/Postal Code
70840-050
Country
Brazil
Facility Name
Hospital Erasto Gaertner
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Pro Onco Centro de Tratamento Oncologico
City
Londrina
ZIP/Postal Code
86050-190
Country
Brazil
Facility Name
Hospital Israelita Albert Einstein
City
Morumbi
ZIP/Postal Code
05651-901
Country
Brazil
Facility Name
Instituto Estadual Arthur de Siqueira Cavalcanti - HEMORIO
City
Rio de Janeiro
ZIP/Postal Code
20211-030
Country
Brazil
Facility Name
Instituto Nacional de Cancer - INCA
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Centro de Estudos e Pesquisas de Hematologia e Oncologia da Faculdade de Medicina do ABC
City
Santo Andre
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Instituto de Ensino e Pesquisa Sao Lucas
City
São Paulo
ZIP/Postal Code
01236-030
Country
Brazil
Facility Name
Fundação Antonio Prudente - AC Camargo Câncer center
City
São Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
MHAT Georgi Stranski PlevenHematology Clinic
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
University hospital Sveti Georgi Hematology Clinic
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Military Medical Academy
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
National Specialized Hospital for Active Treatment of Hematology Diseases
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
University hospital Sveta Marina
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
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
Hospital Charles LeMoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V2H1
Country
Canada
Facility Name
Sacre-Couer Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Instituto Oncologico
City
Renaca
ZIP/Postal Code
2540364
Country
Chile
Facility Name
Instituto Clinico Oncologico del Sur ICOS
City
Temuco
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Oncomedica S.A.
City
Monteria
Country
Colombia
Facility Name
University Hospital Centre Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
General Hospital Sveti Duh
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicka bolnica Dubrava Klinika za unutarnje bolesti Odjel za Hematologiju
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital2.Dep.Intern.Med. Hematology
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Faculty Hospital Kralovske Vinohrady
City
Prague
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Rigshospitalet University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev University Hospital Dep of hematology
City
Harlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Roskilde University Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Bergonie Institut
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Facility Name
CHRU
City
Grenoble cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
CHU Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital de l'Archet 1
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
CHU Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Kaposi Mor Oktato Korhaz
City
Kaposvar
ZIP/Postal Code
7400
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
Petz Aladar Country Hospital
City
Vasvari Pal U. 2
ZIP/Postal Code
9023
Country
Hungary
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
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 Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale San Raffaele S.r.l.
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Europeo di Oncologia - IEO
City
Milan
ZIP/Postal Code
20141
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
Universita del Piemonte Orientale
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
AOU San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Universita degli Studi di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale S. Chiara
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale San Carlo
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Ospedale Umberto I
City
Torrette Di Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Maxima Medisch Centrum
City
Eindhoven
ZIP/Postal Code
5631
Country
Netherlands
Facility Name
Spaame Ziekenhuis
City
Hoofddorp
ZIP/Postal Code
2135
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
North Shore University 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
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika
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
Klinika Chorob wewnetrznych i Hematologii
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Nowotworww Krwi i Transplantacji Szpiku
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
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
Regional Clinical Hospital 1
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Russian Academy of Medical Sciences Institution
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Moscow GUZ City Clinical Hospital
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
NUZ Central Clinical Hospital
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
GUZ Nizhegorodskaya Regional Clinical Hospital
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
MUZ City clinical hospital
City
Novosibirsk
ZIP/Postal Code
630051
Country
Russian Federation
Facility Name
St. Petersburg Research Institute of Hematology and Blood Transfusion
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 Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Narodny onkologicky ustav
City
Bratislava
ZIP/Postal Code
83101
Country
Slovakia
Facility Name
Martinska Fakultna Nemocnica
City
Martin
ZIP/Postal Code
03659
Country
Slovakia
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
Hospital Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
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 Universitario Puerta de Hierro-Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
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 Universitario La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Royal Bournemouth General Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
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
St George's Healthcare NHS Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28140392
Citation
Chanan-Khan A, Egyed M, Robak T, Martinelli de Oliveira FA, Echeveste MA, Dolan S, Desjardins P, Blonski JZ, Mei J, Golany N, Zhang J, Gribben JG. Randomized phase 3 study of lenalidomide versus chlorambucil as first-line therapy for older patients with chronic lymphocytic leukemia (the ORIGIN trial). Leukemia. 2017 May;31(5):1240-1243. doi: 10.1038/leu.2017.47. Epub 2017 Jan 31. No abstract available.
Results Reference
result
Links:
URL
https://www.nature.com/articles/leu201747
Description
Related Info

Learn more about this trial

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

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