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

Condition(s) targeted: B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Intervention: Lenalidomide (Drug); Chlorambucil (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Oliver Kong, MD, Study Director, Affiliation: Celgene Corporation

Overall contact:
Jorge Mouro, Phone: 908-673-2252, Email: origintrial@celgene.com

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.

Official title: A Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group Study Of The Efficacy & Safety Of Lenalidomide (Revlimid®) Vs. Chlorambucil As First-Line Therapy For Previously Untreated Elderly Patients With B-Cell Chronic Lymphocytic Leukemia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression Free Survival (PFS)

Secondary outcome:

Safety [type, frequency, and severity of adverse events (AEs)]

Response, including evaluation of minimal residual disease (MRD) by flow cytometry (Hallek, 2008)

Duration of response

Time to response

Overall survival (OS)

Health-Related Quality of Life (HRQL) by Functional Assessment of Cancer Therapy -Leukemia (FACT-Leu) and EQ-5D

Detailed description: CC-5013-CLL-008 is a Phase 3, multi-center, randomized, open-label, parallel-group study that will compare the efficacy and safety of oral lenalidomide to that of oral chlorambucil in elderly patients with previously untreated B-cell CLL. Eligible patients must not have received any treatment for their B-cell CLL, must be symptomatic, and must be ≥ 65 years of age.

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Must sign an informed consent form.

2. Age ≥ 65 years

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

4. Must have a documented diagnosis of B-cell CLL.

5. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.

6. Must agree to follow pregnancy precautions as required by the protocol.

7. Must agree to receive counseling related to teratogenic and other risks of lenalidomide.

8. Must agree not to donate blood or semen as defined by the protocol

Exclusion Criteria:

1. Prior treatment for B-cell CLL.

2. Any medical condition, that would prevent the subject from signing the informed consent form.

3. Active infections requiring systemic antibiotics.

4. Systemic infection that has not resolved > 2 months prior to initiating lenalidomide

5. Pregnant or lactating females.

6. Participation in any clinical study or having taken any investigational therapy within 28 days.

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

8. Central nervous system (CNS) involvement.

9. Prior history of malignancies, other than CLL, unless the subject has been free of the disease for ≥3 years. Exceptions include the following:

- Basal cell carcinoma of the skin

- Squamous cell carcinoma of the skin

- Carcinoma in situ of the cervix

- Carcinoma in situ of the breast

- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)

10. History of renal failure requiring dialysis.

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

12. Prior therapy with lenalidomide.

13. Evidence of TLS at screening

14. Presence of specific hematology and/or chemistry abnormalities

15. Uncontrolled hyperthyroidism or hypothyroidism

16. Venous thromboembolism within one year

17. ≥ Grade-2 neuropathy

18. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

19. Disease transformation [i. e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia]

Jorge Mouro, Phone: 908-673-2252, Email: origintrial@celgene.com

Flinders Medical Centre, Adelaide 5041, Australia; Recruiting

IMVS, Adelaide 5000, Australia; Recruiting

St. Vincent Hospital, Fitzroy 3065, Australia; Recruiting

Royal Melbourne Hospital, Melbourne 3050, Australia; Withdrawn

Innsbruck Medical University, Innsbruck 6020, Austria; Recruiting

Medical University of Vienna, Vienna 1190, Austria; Terminated

Institut Jules Bordet, Brussels 1000, Belgium; Recruiting

CHU Erasme Clinic of Hematology, Brussels 1070, Belgium; Recruiting

Hopital de Jolimont, Haine Saint Paul 7100, Belgium; Recruiting

AZ Groeninge Kortrijk, Kortrijk 8500, Belgium; Recruiting

UZ Leuven, Leuven 3000, Belgium; Terminated

Clinique Universitaire de Mont Godinne, Yvoir 5530, Belgium; Recruiting

Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos, Brazil; Recruiting

BIOCANCER - Centro de Pesquisa e Tratamento do Câncer S/A, Belo Horizonte, Brazil; Recruiting

Hospital Universitario de Brasilia, Brasílía, Brazil; Recruiting

Hospital Erasto Gaertner, Curitiba, Brazil; Recruiting

Pro Onco Centro de Tratamento Oncológico, Londrina, Brazil; Recruiting

Hospital Israelita Albert Einstein, Morumbi, Brazil; Recruiting

Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil; Recruiting

Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Recruiting

Instituto Nacional Del Cancer, Rio de Janeiro, Brazil; Recruiting

Instituto Estadual Arthur de Siqueira Cavalcanti - HEMORIO, Rio de Janeiro, Brazil; Recruiting

Monte Tabor Hospital Sao Rafael, Salvador, Brazil; Recruiting

Centro de Estudos e Pesquisas de Hematologia e Oncologia da, Santo Andre, Brazil; Recruiting

Fundacao Antonio Prudente - Hospital do Cancer AC Camargo, Sao Paulo, Brazil; Recruiting

Instituto de Ensino e Pesquisa São Lucas, Sao Paulo, Brazil; Recruiting

Clinic of Hematology, Pleven 5800, Bulgaria; Recruiting

Clinic of Hematology, Plovdiv 4002, Bulgaria; Recruiting

Military Medical Academy Clinic of Hematology and Oncology, Sofia 1606, Bulgaria; Recruiting

National Specialized Hospital for Active Treatment of Hematology Diseases, Sofia 1756, Bulgaria; Withdrawn

UMHAT Clinic of Hematology, Varna 9010, Bulgaria; Recruiting

Instituto Oncologico Anabaena 336 Vina del Mar V Region, Renaca 2540364, Chile; Recruiting

Instituto Clinico Oncologico del Sur (ICOS) Lago Puyehue 01745 Temuco IX Region de La Araucania, Temuco 4810469, Chile; Recruiting

University Hospital Dubrava, Zagreb 10000, Croatia; Recruiting

Faculty Hospital Hradec Kralove, Hradec Kralove 50005, Czech Republic; Recruiting

Fakultni nemocnice Ostrava, Ostrava 70852, Czech Republic; Terminated

Ustavni lekarna Fakultni nemocnice Kralovske Vinoh, Praha 10034, Czech Republic; Recruiting

Rigshospitalet University Hospital, Copenhagen 2100, Denmark; Recruiting

Copenhagen University Hospital at Herlev, Herlev 2730, Denmark; Recruiting

Bergoniè Institute, Bordeaux 33300, France; Terminated

Polyclinique Bordeaux Nord Aquitaine, Bordeaux 33300, France; Terminated

Hopital A Michalon, Grenoble 38043, France; Terminated

CHU Dupuytren, Limoges 87042, France; Terminated

Hopital de l'Archet, Nice 06200, France; Terminated

CHU Hautepierre, Strasbourg 67200, France; Terminated

Debreceni Egyetem Orvos - es Egeszsegtudomanyi Cent, Debrecen 4032, Hungary; Recruiting

Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszati Osztaly Haematologia, Gyor 9024, Hungary; Recruiting

Kaposi Mor Oktato Korhaz, Kaposvar 7400, Hungary; Recruiting

Szegedi TudomanyegyetemII Belgyogyaszati Klinika, Szeged 6720, Hungary; Recruiting

Szent Borbala Korhaz, Tatabanya 2800, Hungary; Recruiting

Haemek Medical Center, Afula 18101, Israel; Recruiting

Barzilai Medical Center, Ashkelon 78278, Israel; Recruiting

Soroka Medical Center, Beer-Sheva 84101, Israel; Terminated

Shaare Zedek Medical Center, Jerusalem POB 3235 91031, Israel; Recruiting

Meir Medical Center, Kfar-Saba 44281, Israel; Recruiting

Belinson Hospital, Petah Tikva 49100, Israel; Recruiting

Kaplan Medical Center, Rehovot 76100, Israel; Terminated

Tel Aviv Sourasky Medical Center Hematology Clinic, Tel-Aviv 64239, Israel; Recruiting

Sheba Medical Center, Tel-Hashomer 52621, Israel; Terminated

Ospedali Riuniti Umberto I Lancisi Torrette di Ancona, Ancona 60020, Italy; Recruiting

Azienda Ospedaliera Policlinico di Bari, Bari 70124, Italy; Recruiting

Azienda Ospedaliera Universitaria Careggi, Firenze 50139, Italy; Recruiting

IRCSS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena, Milan 20122, Italy; Terminated

IEO- Istituto Europeo di Oncologia, Milan 20141, Italy; Recruiting

Fondazione San Raffaele del Monte Tabor, Milano 20132, Italy; Recruiting

Ospedale Cardarelli, Naples 80131, Italy; Recruiting

Azienda Ospedaliero Universitaria Maggiore della Carità Di Novara, Novara 28100, Italy; Recruiting

AOU S.Luigi Gonzaga, Orbassano (Torino) 10043, Italy; Recruiting

Azienda Ospedaliero Universitaria di Padova, Padova 35128, Italy; Recruiting

Azienda Ospedaliero Universitaria Pisana - Università degli Studi di Pisa - Ospedale Santa Chiara, Pisa 56126, Italy; Recruiting

Ematologia Azienda Ospedaliera Ospedale San Carlo, Potenza 85100, Italy; Recruiting

AOU Senese - Policlinico S. Maria alle Scotte, Siena 53100, Italy; Recruiting

Christchurch Hospital, Christchurch 8011, New Zealand; Recruiting

Universyteckie Centrum Kliniczn, Gdansk 80-952, Poland; Recruiting

Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Lodz 93-510, Poland; Recruiting

Apteka Szpitalna Specjalistyczny Spital Miejski i, Torun 87-100, Poland; Terminated

Apteka Instytucji WIM, Warsawa 04-141, Poland; Recruiting

Klinika Chorob wewnetrznych i Hematologii, Warsawa 00-909, Poland; Terminated

Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku, Wroclaw 50-367, Poland; Terminated

Hospitais da Universidade de Coimbra E.P.E., Coimbra 3000-075, Portugal; Recruiting

Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E., Oporto 4200-072, Portugal; Recruiting

Spitalul Clinic Coltea, Bucharest 030171, Romania; Recruiting

Institutul Clinic Fundeni, Bucharest 022328, Romania; Recruiting

Spitalul Clinic Judetean de Urgenta "Sf Spiridon", Iasi 700111, Romania; Recruiting

Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu 550245, Romania; Terminated

Spitalul Clinic Municipal de Urgenta Timisoara, Timisoara 300079, Romania; Terminated

Arkhangelsk Regional Clinical Hospital, Arkhangelsk 163045, Russian Federation; Recruiting

City Hospital, Barnaul 659010, Russian Federation; Recruiting

Regional Clinical Hospital, Ekaterinburg 620102, Russian Federation; Recruiting

GU Russian Oncological Research Center, Moscow 115447, Russian Federation; Recruiting

NUZ Central Clinical Hospital, Moscow 129128, Russian Federation; Withdrawn

GUZ Moscow City Clinical Hospital n.a.S.P. Botkin of Department of Moscow, Moscow 125284, Russian Federation; Recruiting

GUV Nizhegorodskaya Regional Clinical Hospital, Nizhniy Novgorod 603126, Russian Federation; Recruiting

MUZ Clinical Hospital, Novosibirsk 630051, Russian Federation; Terminated

FGU Russian Scientific Research Institute of Hematology and Transfusiology, St. Petersburg 191024, Russian Federation; Recruiting

GUS Leningrad Regional Clinical Hospital, St. Petersburg 194291, Russian Federation; Recruiting

Federal State Institution Federal Centre of Heath, St. Petersburg 197341, Russian Federation; Recruiting

Clinical Center Kragujevac, Kragujevac 34000, Serbia; Recruiting

Clinical Center Nis, Nis 18000, Serbia; Recruiting

Narodny Onkologicky Ustav, Bratislava 83101, Slovakia; Recruiting

Martinska Fakultna Nemocnica Clinic of Hematology and Transusiology, Martin 03659, Slovakia; Recruiting

University of Witwatersrand - Department of Medical Oncology, Johannesburg 2193, South Africa; Recruiting

Mary Potter Oncology Centre, Pretoria 0181, South Africa; Recruiting

Hospital Germans Trias i Pujol, Barcelona 08916, Spain; Recruiting

Hospital Universitario Vall d'Hebron, Barcelona 08035, Spain; Recruiting

Hospital Universitario Ramon y Cajal, Madrid 28034, Spain; Terminated

Hospital Universitario la Princesa, Hematologia Planta 6, Madrid 28006, Spain; Recruiting

Hospital General Universitario Morales Meseguer, Murcia 30008, Spain; Recruiting

Hospital Donostia, Hematologia, Paseo del Beguiristain s/n Donostia (San Sebastian), Pais Vasco 20014, Spain; Recruiting

Hospital Clinico Universitario de Salamanca, Salamanca 37007, Spain; Terminated

Hospital Marquezs de Valdecilla, Santander 39008, Spain; Terminated

Hospital Universitario La Fe, Valencia 46009, Spain; Recruiting

Royal Bournemouth Hospital, Bournemouth BH7 7DW, United Kingdom; Recruiting

St. Bartholomew's and The Royal London Hospital, London EC1A7BE, United Kingdom; Recruiting

St. George's Healthcare NHS Trust, London SW170QT, United Kingdom; Recruiting

Southwest Cancer Care Medical Group, Escondido, California 92025, United States; Recruiting

The Hospital of Central Connecticut, New Britain, Connecticut 06050, United States; Recruiting

Cancer Center of Central Connecticut, Southington, Connecticut 06489, United States; Recruiting

Oncomedica S.A, Monteria, Cordoba, Colombia; Recruiting

Pretoria Academic & Steve Biko Hospitals, Pretoria, Gauteng 0002, South Africa; Recruiting

North Chicago VA Medical Center, North Chicago, Illinois 60064, United States; Recruiting

Medical Consultants, PC c/o Cancer Center @ BMH, Muncie, Indiana 47303, United States; Terminated

Floyd Memorial Cancer Care Center of Indiana, New Albany, Indiana 47150, United States; Terminated

Purchase Cancer Group, Paducah, Kentucky 42001, United States; Recruiting

Hospital Puerta de Hierro, Majadahonda, Madrid 28222, Spain; Terminated

Division of Hematology, Oncology and Transplantation University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting

Saint Louis University Cancer Center - Division of Hematology Oncology, Saint Louis, Missouri 63110, United States; Terminated

Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States; Recruiting

Atlantic Health Sciences Corporation Saint John Regional Hospital, Saint John, New Brunswick E2L- 4L2, Canada; Recruiting

Oncology & Hematology Specialists, PA, Denville, New Jersey 07834, United States; Terminated

The Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey 07601, United States; Withdrawn

Somerset Hematology Oncology Associates, Somerville, New Jersey 08876, United States; Recruiting

Nepean Cancer Care Centre, Kingswood, New South Wales 2751, Australia; Recruiting

Calvary Mater Hospital, Newcastle, New South Wales 2298, Australia; Recruiting

Westmead Hospital, Northmead, New South Wales 2152, Australia; Recruiting

Roswell Park Cancer Center, Buffalo, New York 14263, United States; Active, not recruiting

New York Medical College, Division of Oncology, Valhalla, New York 10595, United States; Recruiting

Health Sciences Center, St. Johns, Newfoundland and Labrador A1B3V6, Canada; Recruiting

Gabrail Cancer Center, Canton, Ohio 44718, United States; Recruiting

Drexel University College of Medicine, Philadelphia, Pennsylvania 19102, United States; Terminated

Pottstown Memorial Medical Center, Pottstown, Pennsylvania 19464, United States; Recruiting

Berks Hematology-Oncology Associates, West Reading, Pennsylvania 19611, United States; Recruiting

Hopital Charles LeMoyne, Greenfield Park, Quebec J4V 2H1, Canada; Recruiting

Hopital du Sacre-Coeur de Montreal, Montreal, Quebec H4J 1C5, Canada; Recruiting

Princess Alexandra Hospital, Woolloongabba, Queensland 4102, Australia; Recruiting

Charleston Hematology and Oncology, Charleston, South Carolina 29403, United States; Recruiting

South Carolina Cancer Specialists, Hilton Head Island, South Carolina 29926, United States; Recruiting

Central Texas Veterans Health Care System, Temple, Texas 76504, United States; Recruiting

The Western Hospital, Footscray, Victoria 3011, Australia; Recruiting

Swedish Tumor Institute-Medical Oncology, Seattle, Washington 98104, United States; Recruiting

Providence St. Mary Regional Cancer Center, Walla Walla, Washington 99362, United States; Recruiting

Columbia St. Mary's Cancer Center, Milwaukee, Wisconsin 53211, United States; Terminated

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Starting date: May 2009
Last updated: January 16, 2013