A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy

NCT ID: NCT00774345

Last Updated: 2021-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 317 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-27
• Study Completion Date: 2020-10-27

Brief Summary

The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug.

Detailed Description

This is a phase 3, randomized (computer assigned by chance to treatment arm), study being completed an multiple sites to compare the safety and efficacy (how well a drug works) of lenalidomide maintenance therapy to placebo (dummy capsule that contains no lenalidomide or active substances) maintenance therapy.

Patients are assigned by a computer with a 50/50 chance to receive placebo or lenalidomide study treatment. Study drug will be taken once each day until the patient discontinues the study. Patients will remain on study drug until progression of disease.

Patients will visit their study doctor every 28 days until disease progression to complete safety and efficacy assessments. Quality of life assessments will be completed every other month. If a patient who discontinue study drug prior to disease progression (i.e. due to an adverse reaction to the study drug), they will continue to visit the study doctor each month to complete the efficacy assessments up to progression of disease. Safety assessments may include laboratory blood tests, ECG tests and questions about any medical conditions or side effects experienced during the study. Efficacy assessments may include laboratory blood tests and focused physical exams.

Computed tomography (CT) scans along with blood tests and bone marrow samples will be collected to confirm if a patient has improvement of response while on study.

After disease progression, patients will be contacted every 12 weeks for survival information, next CLL treatments and quality of life questions.

Subjects currently on lenalidomide treatment will discontinue lenalidomide treatment immediately and complete the Treatment Discontinuation assessment. The subjects will then transition to the survival follow-up period.

Conditions

B-cell Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: 1

Lenalidomide po qd on days 1-28 of a 28 day cycle

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

Lenalidomide capsules given orally on days 1-28 of a 28 day cycle

Placebo Comparator: 2

Placebo capsules given orally on days 1-28 of a 28 day cycle

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsules given orally on days 1 - 28 of a 28 day cycle

Interventions

Lenalidomide

Lenalidomide capsules given orally on days 1-28 of a 28 day cycle

Intervention Type: DRUG

Placebo

Placebo capsules given orally on days 1 - 28 of a 28 day cycle

Intervention Type: DRUG

Other Intervention Names

Revlimid

Eligibility Criteria

Inclusion Criteria

1. Must understand and voluntarily sign an informed consent form.

2. Must be greater than or equal to 18 years at the time of signing the informed consent form.

3. Must be able to adhere to the study visit schedule and other protocol requirements.

4. Must have a documented diagnosis of B-cell CLL (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia [Hallek, 2008]).

5. Must have been treated with one of the following in first and/or second line:

• a purine analog-containing regimen
• a bendamustine-containing regimen
• an anti-CD20 antibody-containing regimen
• a chlorambucil-containing regimen
• an alemtuzumab-containing regimen (for those subjects with a 17p deletion)

6. Must have achieved a minimum response of partial response (PR, nPR, CRi, CR, and MRD-negative CR) (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia [Hallek, 2008]) following completion of second-line induction therapy prior to randomization (documentation of response status must be available). Second-line induction therapy must be documented to have been of sufficient duration.

7. Must have completed last cycle of second-line induction no less than 8 weeks (56 days) and no greater than 20 weeks (140 days) prior to randomization.

8. Must have an ECOG performance status score of less than or equal to 2.

9. Females of childbearing potential (FCBP)† must:

• Have two negative medically supervised pregnancy tests prior to starting of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices complete and continued sexual abstinence.
• Either commit to continued abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.

10. Male subjects must:

• Commit to continued abstinence from heterosexual contact or agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
• Agree to not donate semen during study drug therapy and for a period after end of study drug therapy.

11. All subjects must:

• Have an understanding that the study drug could have a potential teratogenic risk.
• Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. • Agree not to share study medication with another person.
• All subjects must be counseled about pregnancy precautions and risks of fetal exposure.

Exclusion Criteria

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

2. Active infections requiring systemic antibiotics.

3. Systemic infection that has not resolved > 2 months prior to initiating lenalidomide treatment in spite of adequate anti-infective therapy

4. Autologous or allogeneic bone marrow transplant as second-line therapy.

5. Pregnant or lactating females.

6. Systemic treatment for B-cell CLL in the interval between completing the last cycle of second-line induction therapy and randomization.

7. Participation in any clinical study or having taken any investigational therapy for a disease other than CLL within 28 days prior to initiating maintenance therapy.

8. Known presence of alcohol and/or drug abuse.

9. Central nervous system involvement as documented by spinal fluid cytology or imaging. Subjects who have signs or symptoms suggestive of leukemic meningitis or a history of leukemic meningitis must have a lumbar puncture procedure performed within two weeks prior to randomization.

10. Prior history of malignancies, other than CLL, unless the subject has been free of the disease for ≥5 years. Exceptions include the following:

• Basal cell carcinoma of the skin
• Squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix
• Carcinoma in situ of the breast
• Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)

11. History of renal failure requiring dialysis.

12. Known Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), and/or active Hepatitis C Virus (HCV) infection.

13. Prior therapy with lenalidomide.

14. Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be enrolled upon correction of electrolyte abnormalities).

15. Any of the following laboratory abnormalities:

• Calculated (method of Cockroft-Gault) creatinine clearance <60 mL/min.
• Absolute neutrophil count (ANC) <1,000/μL (1.0 X 109/L)
• Platelet count <50,000/μL (50 X 109/L)
• Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN)
• Serum total bilirubin >2.0 mg/dL (with the exception of Gilbert's Syndrome)

16. Grade 4 rash due to prior thalidomide treatment

17. Uncontrolled hyperthyroidism or hypothyroidism

18. Venous thromboembolism within one year

19. Greater than or equal to Grade-2 neuropathy

20. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

21. Disease transformation (active) (ie, Richter's Syndrome, prolymphocytic leukemia)

22. Known allergy to allopurinol for subjects assessed with PR following their second-line induction therapy.

23. Prisoners.

24. More than 2 prior lines of CLL therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Delarue, MD

Role: STUDY_DIRECTOR

Celgene Corporation

Locations

Mayo Clinic - Arizona

Phoenix, Arizona, United States

Pacific Coast Hematology Oncology

Fountain Valley, California, United States

Kaiser Permanente Medical Group

San Diego, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Stanford University Stanford

Stanford, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Cancer Center of Central Connecticut

Plainville, Connecticut, United States

Boca Raton Community Hospital

Boca Raton, Florida, United States

Pasco Hernando Oncology Associates, PA

Brooksville, Florida, United States

Memorial Hospital

Hollywood, Florida, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Florida Cancer Specialist

Tavares, Florida, United States

Florida Hospital Cancer Institute Waterman

Tavares, Florida, United States

Augusta Oncology Associates, P.C.

Augusta, Georgia, United States

Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute

Marietta, Georgia, United States

Northwestern University, Division of Hematology Oncology, Dept. of Medicine

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Edward Hines Jr VA Hospital

Hines, Illinois, United States

North Chicago VA Medical Center

North Chicago, Illinois, United States

Hematology Oncology Assoc. of IL Orchard Research LLC

Skokie, Illinois, United States

Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services

New Albany, Indiana, United States

McFarland Clinic

Ames, Iowa, United States

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Ochsner Medical Institutions

New Orleans, Louisiana, United States

Clinical Unit for Research Trials in Skin CURTIS Massachusetts General Hospital

Boston, Massachusetts, United States

Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

The Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Winthrop University Hospital

Mineola, New York, United States

Biomedical Research Alliance of New York, LLC

New Hyde Park, New York, United States

SUNY Upstate Medical University Medicine Oncology

Syracuse, New York, United States

Westchester County Medical Center

Valhalla, New York, United States

Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

The Christ Hospital

Cincinnati, Ohio, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Hematology Oncology Consultants, Inc.

Columbus, Ohio, United States

Gabrail Cancer Center Research

Dover, Ohio, United States

Trilogy Cancer Care

Wooster, Ohio, United States

Kaiser Permanente Northwest Oncology Hematology

Portland, Oregon, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

Gettysburg Cancer Center

Gettysburg, Pennsylvania, United States

Drexel University, College of Medicine, Clinical Research Group

Philadelphia, Pennsylvania, United States

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Abington Hematology Oncology Associates Inc

Willow Grove, Pennsylvania, United States

Charleston Hematology Oncology P.A.

Charleston, South Carolina, United States

M. Francisco Gonzalez, MD, PA

Sumter, South Carolina, United States

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, United States

Gundersen Clinic Lutheran Hospital

La Crosse, Wisconsin, United States

Concord Hospital

Concord, New South Wales, Australia

Haematology and Oncology Clinics of Australasia

South Brisbane, Queensland, Australia

IMVS

Adelaide, South Australia, Australia

Flinders Medical Centre

Bedford Park, , Australia

Royal Prince Alfred Hospital

Camperdown, , Australia

Peter MacCallum Cancer Centre

East Melbourne, , Australia

Frankston Hospital

Farkston, , Australia

St. Vincent Hospital

Fitzroy, , Australia

Nepean Hospital

Kingswood, NSW, , Australia

Clinical Trials Unit The St George Hospital

Kogarah, , Australia

Sir Charles Gairdner Hospital

Nedlands, , Australia

Royal North Shore HospitalDepartment of HematologyLevel 4

St Leonards, , Australia

The Queen Elizabeth Hospital

Woodville, , Australia

Universitaetsklinik Innsbruck

Innsbruck, , Austria

Hospital Bamherzige Schwestern

Linz, , Austria

Medical University of Vienna Internalmedicine 1, Hematology

Vienna, , Austria

AZ Sint-Jan AV Brugge

Bruges, , Belgium

Institut Jules Bordet

Brussels, , Belgium

Cliniques Universitaires St Luc

Brussels, , Belgium

UZ Gent Hematology

Ghent, , Belgium

Hopital de Jolimont

Haine-Saint-Paul, , Belgium

AZ Groeninge

Kortrijk, , Belgium

UZ Leuven

Leuven, , Belgium

CHU Mont -Godinne

Yvoir, , Belgium

Regional Health Authority B-Saint John Regional Hospital

Saint John, New Brunswick, Canada

General Hospital, Eastern Health

St. John's, Newfoundland and Labrador, Canada

CDHA Centre for Clinical Research

Halifax, Nova Scotia, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

McGill University

Montreal, Quebec, Canada

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

CIUSSS de l'Est-de-l'Ile-de-Montreal

Montreal/Quebec, Quebec, Canada

Hopital De L'Enfant-Jesus

Québec, , Canada

Oncomedica S.A.

Montería, , Colombia

Interni hematoonkologicka klinika

Brno, , Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Poliklinika Agel Novy Jicin

Nový Jičín, , Czechia

Faculty Hospital Plzen

Pilsen, , Czechia

Faculty Hospital Kralovske Vinohrady

Prague, , Czechia

General Faculty Hosital1.Internal Clinic

Prague, , Czechia

Rigshospitalet University Hospital

Copenhagen, , Denmark

Odense University Hospital

Odense, , Denmark

Vejle Hospital

Vejle, , Denmark

Hopital Aviecenne

Bobigny, , France

Bergonie Institut

Bordeaux, , France

CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire

Clermont-Ferrand, , France

CHU Hopital Michallon

Grenoble, , France

Centre Hospitalier Lyon Sud

Lyon, , France

Cetre Hospitalier Hotel-Dieu

Nantes, , France

Hopital de l'Archet 1

Nice, , France

Hopital Petie- SalpetriereDepartment d'Hematologie

Paris, , France

CHU La Miletrie

Poitiers, , France

CHU de Reims

Reims, , France

CLCC H BecquerelHematology

Rouen, , France

Hopital Bretonneau

Tours, , France

Charite, Campus Benjamin Franklin, Medizinische Klinik III

Berlin, , Germany

Klinikum der Universitat zu Koln

Cologne, , Germany

Universitaetsklinikum EssenZentrum fuer Innere Medizin

Essen, , Germany

Innere Medizin Klinikum Frankfurt Oder GmBH

Frankfurt (Oder), , Germany

Universitaetsklinikum FreiburgInnere Med.1, Haematologie

Freiburg im Breisgau, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Praxis fuer Haematologie und Onkologie Koblenz

Koblenz, , Germany

Universitatsklinikum Leipzig

Leipzig, , Germany

Mannheimer Onkologie Praxis

Mannheim, , Germany

Stadtisches Klinikum Munchen GmbH

München, , Germany

TU München - Klinikum rechts der Isar

München, , Germany

Facharzte fur Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis

Münster, , Germany

University Hospital of Ulm

Ulm, , Germany

Semmelweis Egyetem

Budapest, , Hungary

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

Debrecen, , Hungary

Petz Aladar Country Hospital

Győr, , Hungary

Kaposi Mor Oktato Korhaz

Kaposvár, , Hungary

Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar

Pécs, , Hungary

Szegedi TudomanyegyetemII Belgyogyaszati Klinika

Szeged, , Hungary

Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza

Tatabánya, , Hungary

St James's Hospital

Dublin, , Ireland

Midwestern Regional Hospital

Limerick, , Ireland

Ha'Emek Medical Center

Afula, , Israel

Barzilai Medical Center

Ashkelon, , Israel

Soroka University Medical Center

Beersheba, , Israel

Bnei Zion Medical Center

Haifa, , Israel

Rambam Health Care Campus

Haifa, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Western Galilee Hospital

Nahariya, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Kaplan Medical Center

Rehovot, , Israel

Tel Aviv Sourasky Medical Center Department of Hematology

Tel Aviv, , Israel

Sheba Medical Center

Tel Litwinsky, , Israel

Azienda Ospedaliera Poloclinico di Bari

Bari, , Italy

Istituto dei Tumori Giovanni Paolo II di Bari

Bari, , Italy

AO Spedali Civili di Brescia

Brescia, , Italy

Azienda Ospedaliera Vittorio Emanuele-Ferrarotto

Catania, , Italy

A.O. Pugliese Ciaccio

Catanzaro, , Italy

Azienda Ospedaliera Annunziala

Cosenza, , Italy

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

Ferrara, , Italy

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Azienda Ospedaliero Universitaria OORR Foggia

Foggia, , Italy

Azienda Ospedaliera San Martino

Genova, , Italy

IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

Milan, , Italy

Fondazione Centro San Raffaele del Monte Tabor

Milan, , Italy

Istituto Oncologico Europeo

Milan, , Italy

Azienda Ospedaliero Universitaria di Modena

Modena, , Italy

Ospedale Cardarelli

Naples, , Italy

Policlinico Universitario Federico II

Naples, , Italy

Universita del Piemonte Orientale

Novara, , Italy

Universita degli Studi di Padova

Padua, , Italy

Azienda Ospedaliera Ospedale San Carlo

Potenza, , Italy

Ospedale Sant'Eugenio

Rome, , Italy

Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

Rome, , Italy

Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

Siena, , Italy

Osp. S.Giovanni Battista Le Molinette

Torino, , Italy

Ospedale Umberto I

Torrette Di Ancona, , Italy

Ospedale San Bortolo di Vicenza

Vicenza, , Italy

Instituto Biomedico de Investigacion AC

Aguascalientes, , Mexico

VU University Medical Center

Amsterdam, , Netherlands

Christchurch Hospital

Christchurch, , New Zealand

Middlemore Clinical Trials

Manukau, , New Zealand

North Shore Hospital

Takapuna, , New Zealand

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Malopolskie Centrum Medyczne S.C.

Krakow, , Poland

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

Lodz, , Poland

Specjalistyczny Szpital miejski im. Kopernika

Torun, , Poland

Centralny Szpital Kliniczny MON

Warsaw, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

Wroclaw, , Poland

Hospitais da Universidade de Coimbra

Coimbra, , Portugal

Hospital de Dia de Hematologia

Lisbon, , Portugal

Instituto Portugues Oncologia do Porto Francisco Gentil EPE

Porto, , Portugal

Institutul Clinic Fundeni

Bucharest, , Romania

Spitalul Clinic Coltea

Bucharest, , Romania

Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi

Iași, , Romania

Spitalul Clinic Judetean de Urgenta Sibiu

Sibiu, , Romania

Spitalul Clinic Municipal de Urgenta Timisoara

Timișoara, , Romania

Archangelsk Regional Clinical Hospital

Arkhangelsk, , Russia

City Hospital 8

Barnaul, , Russia

GMU Republic clinical hospital

Kazan', , Russia

Krasnoyarsk Regional Clinical Hospital

Krasnoyarsk, , Russia

Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl

Moscow, , Russia

State Budgetary Institution of the City of Moscow

Moscow, , Russia

NUZ Central Clinical Hospital

Moscow, , Russia

Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko

Nizhny Novgorod, , Russia

MUZ City Clinical Hospital 2

Novosibirsk, , Russia

Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so

Obninsk, , Russia

FGU Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency

Saint Petersburg, , Russia

GUS Leningrad Regional Clinical Hospital

Saint Petersburg, , Russia

St. Petersburg Pavlov State Medical Univ

Saint Petersburg, , Russia

Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies

Saint Petersburg, , Russia

Saratov State Medical University

Saratov, , Russia

GUZ Volgograd Regional Clinical Oncology

Volgograd, , Russia

State Healthcare Institution Sverdlovsk regional clinical hospital 1

Yekaterinburg, , Russia

Groote Schuur Hospital

Cape Town, , South Africa

University Witwatersrand Oncology

Parktown, , South Africa

Pretoria Academic Hospital

Pretoria, , South Africa

Mary Potter Oncology Centre

Pretoria, , South Africa

Wilgers Oncology CentreWilgrers Hospital

Pretoria, , South Africa

Hospital Germans Trias I Pujol

Badalona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitario Vall D hebron

Barcelona, , Spain

Hospital Donostia

Donostia / San Sebastian, , Spain

Hospital Universitario de la Princesa

Madrid, , Spain

Hospital Ramon y Cajal

Madrid, , Spain

Hospital 12 de Octubre

Madrid, , Spain

Hospital La Paz

Madrid, , Spain

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, , Spain

Virgen de la Victoria Hospital Malaga

Málaga, , Spain

Hospital General Universitario Morales Messeguer

Murcia, , Spain

Hospital Universitario de Salamanca

Salamanca, , Spain

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Hospital Clinico Universitario

Valencia, , Spain

Skane University Hospital

Lund, , Sweden

Stockholm South Hospital

Stockholm, , Sweden

Karolinska University

Stockholm, , Sweden

Royal Bournemouth General Hospital

Bournemouth, , United Kingdom

Addenbrookes Hospital

Cambridge, , United Kingdom

Gartnavel General Hospital

Glasgow, , United Kingdom

John Radcliffe Hospital

Headington, , United Kingdom

Saint James University Hospital

Leeds, , United Kingdom

Royal Liverpool University Hospital

Liverpool, , United Kingdom

St. Bartholomew's and The Royal London Hospital

London, , United Kingdom

Guy's and St. Thomas' Hospital

London, , United Kingdom

King's College Hospital

London, , United Kingdom

St George's Healthcare NHS Trust

London, , United Kingdom

Christie Hospital NHS Foundation Trust

Manchester, , United Kingdom

Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

Sheffield, , United Kingdom

Singleton Hospital, Southwest Wales Cancer Inst

Swansea, , United Kingdom

Sandwell Hospital

West Bromwich, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; Colombia; Czechia; Denmark; France; Germany; Hungary; Ireland; Israel; Italy; Mexico; Netherlands; New Zealand; Poland; Portugal; Romania; Russia; South Africa; Spain; Sweden; United Kingdom

References

Chanan-Khan AA, Zaritskey A, Egyed M, Vokurka S, Semochkin S, Schuh A, Kassis J, Simpson D, Zhang J, Purse B, Foa R. Lenalidomide maintenance therapy in previously treated chronic lymphocytic leukaemia (CONTINUUM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2017 Nov;4(11):e534-e543. doi: 10.1016/S2352-3026(17)30168-0. Epub 2017 Sep 25.

Reference Type: DERIVED

PMID: 28958469 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CC-5013-CLL-002

Identifier Type: -

Identifier Source: org_study_id