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Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma, Non-Hodgkin

Intervention: Rituximab (Drug); Lenalidomide (Drug); Rituximab (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Celgene Corporation

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

Overall contact:
Emmanual Ryembault, MS Neuropsychopharmacology, Email: clinicaltrialdisclosure@celgene.com

Summary

This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.

Clinical Details

Official title: A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma.

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Progression free survival (PFS) for indolent lymphoma (Follicular lymphoma and Marginal zone lymphoma

Secondary outcome:

Overall response rate for indolent lymphoma (Follicular lymphoma and Marginal zone lymphoma)

Durable complete response rate for indolent lymphoma (Follicular lymphoma and Marginal zone lymphoma)

Overall survival for indolent lymphoma (Follicular lymphoma and Marginal zone lymphoma)

Duration of response for indolent lymphoma (Follicular lymphoma and Marginal Zone lymphoma)

Event Free Survival for indolent lymphoma (Follicular lymphoma and Marginal Zone lymphoma)

Time to next anti-lymphoma therapy (TTNLT) for indolent lymphoma (Follicular lymphoma and Marginal Zone lymphoma)

Safety in indolent lymphoma (Follicular lymphoma and Marginal Zone lymphoma)

Detailed description: Indolent lymphoma is a slow growing but incurable lymphoma which includes follicular lymphoma and marginal zone lymphoma. Follicular Lymphoma and Marginal zone lymphoma are cancers of the B lymphocyte, a type of white blood cell. Lenalidomide is an immunomodulatory drug (a drug that affects the immune system) which alters the body's immune system and it may also interfere with the development of tiny blood vessels involved in tumor growth. Therefore, lenalidomide may reduce or prevent the growth of cancer cells. Lenalidomide has also been shown to restore the immune cells' ability to attack and kill tumor cells, an ability that may be inhibited by follicular lymphoma and other lymphomas. The combination of rituximab and lenalidomide may eliminate the cancer while restoring the immune system's ability to attack tumor cells.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age ≥18 years

- Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1,

2 or 3a)

- Documented relapsed, refractory or progressive disease after treatment with

systemic therapy

- Rituximab naïve or rituximab sensitive

- Investigator considers rituximab monotherapy appropriate

- Bi-dimensionally measurable disease

- Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2

- Adequate bone marrow function

- Willingness to follow pregnancy precautions

Exclusion Criteria:

- Histology other than follicular or marginal zone lymphoma or clinical evidence of

transformation or Grade 3b follicular lymphoma

- Subjects taking corticosteroids during the last week, unless administered at a

dose equivalent to < 20 mg/day prednisone or prednisolone

- Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8

weeks use of radioimmunotherapy within 6 months

- Known seropositive for or active viral infection with hepatitis B virus (HBV),

hepatitis C virus (HCV), human immunodeficiency virus (HIV)

- Known sensitivity or allergy to murine products

- Presence or history of central nervous system involvement by lymphoma.

- Subjects who are at a risk for a thromboembolic event and are not willing to

take prophylaxis for it.

- Any condition that places the subject at unacceptable risk if he/she were to

participate in the study or that confounds the ability to interpret data from the study.

Locations and Contacts

Emmanual Ryembault, MS Neuropsychopharmacology, Email: clinicaltrialdisclosure@celgene.com

AZ St-Jan Brugge Oostende AV, Brugge 8000, Belgium; Recruiting

UZ Gent, Gent 9000, Belgium; Recruiting

AZ Groeninge, Kortrijk 8500, Belgium; Recruiting

CHU Mont -Godinne, Yvoir 5530, Belgium; Recruiting

MS INCA HC I Hospital do Câncer I, Rio De Janeiro 20231-130, Brazil; Recruiting

Fundação Antonio Prudente - AC Camargo Câncer center, São Paulo 01509-900, Brazil; Recruiting

Real e Benemérita Associaçao Portuguesa de Beneficência, São Paulo 01321-001, Brazil; Recruiting

Sociedade Beneficente de Senhoras Hospital Sirio Libanes, São Paulo 01308 050, Brazil; Recruiting

Beijing Cancer Hospital, Beijing, PR 100142, China; Recruiting

307 Hospital of PLA, Beijing 100071, China; Recruiting

Cancer Hospital Chinese Academy of Medical Sciences, Beijing 100021, China; Not yet recruiting

Peking Union Medical College Hospital, Beijing 100730, China; Recruiting

Peking University People's Hospital, Beijing 100044, China; Not yet recruiting

The Third Xiangya hospital of central south university, Changsha 410013, China; Recruiting

West China Hospital of Sichuan University, Chengdu 610041, China; Not yet recruiting

Fujian Medical University Union Hospital, Fuzhou 350001, China; Recruiting

Guangdong General Hospital, Guangzhou 510080, China; Recruiting

Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Recruiting

The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou City 310003, China; Recruiting

Jiangsu Province Hospital/ The First Hospital affiliated with Nanjing Medical University, Nanjing 210029, China; Recruiting

Cancer Hospital, Fudan University, Shanghai 200032, China; Recruiting

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China; Not yet recruiting

The First Affiliated Hospital of Soochow University, Suzhou 215006, China; Recruiting

Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China; Recruiting

Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China; Recruiting

Xijing Hospital, Xi'an 710032, China; Recruiting

Interni hematoonkologicka klinika, Brno 625 00, Czech Republic; Recruiting

Fakultni nemocnice Hradec Kralove, IV.interni hematologicka klinika, Hradec Kralove 500 05, Czech Republic; Recruiting

Fakultni Nemocnice Ostrava, Klinika hematoonkologie,, Ostrava 70852, Czech Republic; Recruiting

Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika, Prague 10 100 34, Czech Republic; Recruiting

Medical Clinical Charles University Hospital, Prague 2 12808, Czech Republic; Recruiting

CHU d'Angers, Angers 49033, France; Recruiting

Centre Hospitalier Universitaire d'Avicennes, Bobigny Cedex 93009, France; Recruiting

Hôpital Augustin Morvan, Brest Cedex 29609, France; Recruiting

CH Perpignan - Hopital Saint-Jean, Perpignan 66046, France; Recruiting

CHU de Poitiers, Poitiers 86021, France; Completed

Centre Hospitalier de Valence, Valence 26953, France; Recruiting

Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum, Berlin 13353, Germany; Recruiting

Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin, Berlin 12203, Germany; Recruiting

Krankenhaus Nordwest, Frankfurt 60488, Germany; Recruiting

Onkologische Schwerpunktpraxis Leer - Emden, Leer 26789, Germany; Recruiting

Kliniken Maria Hilf GmbH, Mönchengladbach 41063, Germany; Recruiting

Klinkum der Stadt Villingen-Schwenningen GmbH, Villingen-Schwenningen 78052, Germany; Recruiting

Soroka University Medical Center, Beer Sheva 84101, Israel; Recruiting

Hadassah University Hospital, Jerusalem 91120, Israel; Recruiting

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

Centro di Riferimento Oncologico - IRCCS, Aviano (PN) 33081, Italy; Recruiting

A.O.U. di Bologna Policlinico S.Orsola-Malpighi, Bologna 40138, Italy; Recruiting

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.), Meldola 47014, Italy; Recruiting

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

IRCCS- Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione "G. Pascale", Napoli 80131, Italy; Recruiting

Azienda Ospedaliero-Universitaria di Parma, Parma 43100, Italy; Recruiting

Ospedale di Ravenna, Ravenna 48121, Italy; Recruiting

Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria 89100, Italy; Recruiting

Ospedale degli Infermi di Rimini, Rimini 47900, Italy; Recruiting

Azienda Ospedaliera S. Andrea - Università La Sapienza, Roma 00189, Italy; Recruiting

National Cancer Center Hospital, Chuo-ku 104-0045, Japan; Not yet recruiting

Chugoku Central Hospital, Hiroshima 7200001, Japan; Recruiting

National Cancer Center Hospital East, Kashiwa 277-8577, Japan; Recruiting

Kobe City Medical Center General Hospital, Kobe-city 650-0047, Japan; Recruiting

The Cancer Institute Hospital of Japanese Foundation For Cancer Research, Koto-ku 135-8550, Japan; Recruiting

University Hospital, Kyoto Prefectural University of Medicine, Kyoto-city 602-8566, Japan; Recruiting

Toranomon Hospital, Minato-ku 105-8470, Japan; Recruiting

The Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki 852-8511, Japan; Recruiting

Nagoya Medical Center,Division of Hematology/Oncology, Nagoya 460-0001, Japan; Recruiting

National University Corporation Tohoku University, Tohoku University Hospital, Sendai-shi 980-8574, Japan; Recruiting

Malopolskie Centrum Medyczne S.C., Kraków 30-510, Poland; Recruiting

Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie, Warszawa 02-781, Poland; Recruiting

Instytut Hematologii i Transfuzjologii w Warszawie, Warszawa 02-776, Poland; Recruiting

Instituto Português de Oncologia de Lisboa, Francisco Gentil, Lisboa 1099-023, Portugal; Recruiting

Instituto Português de Oncologia do Porto, Francisco Gentil, Porto 4200-072, Portugal; Recruiting

Krasnoyarsk Regional Clinical Hospital, Krasnoyarsk 660022, Russian Federation; Recruiting

Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin, Moscow 125101, Russian Federation; Recruiting

Russian Academy of Medical Sciences Institution, Moscow 115478, Russian Federation; Recruiting

Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov, St Petersburg 197341, Russian Federation; Recruiting

St. Petersburg Pavlov State Medical University, St.Petersburg 197022, Russian Federation; Recruiting

The Ministry of Health and Social Development of the Tula region state institution Health Tula regio, Tula 300053, Russian Federation; Recruiting

Hospital de la Santa Creu i Sant Pau, Barcelona 08041, Spain; Recruiting

Hospital Universitario Reina Sofia, Córdoba 14004, Spain; Recruiting

Hospital Universitario Fundacion Jimenez Diaz, Madrid 28040, Spain; Recruiting

Hospital Universitario Infanta Leonor, Madrid 28031, Spain; Recruiting

Hospital Costa del Sol, Marbella 29603, Spain; Recruiting

Hospital Morales Meseguer, Murcia 30008, Spain; Recruiting

Hospital Universitario de Salamanca, Salamanca 37007, Spain; Recruiting

Cukurova University Medical Faculty Balcali Hospital, Adana 01330, Turkey; Recruiting

Hacettepe Üniversitesi, Ankara 06100, Turkey; Recruiting

Pamukkale University Medical Faculty, Denizli 20070, Turkey; Recruiting

Gaziantep University, Gaziantep 27310, Turkey; Recruiting

Marmara University, Istanbul 34840, Turkey; Recruiting

Dokuz Eylul University (Izmir), Izmir 35340, Turkey; Recruiting

19 Mayis Medical Faculty - Samsun, Samsun 55139, Turkey; Recruiting

Kocaeli Universitesi Tip Fakultesi Ic Hastaliklari, Umuttepe Kocaeli 41380, Turkey; Recruiting

Eastbourne District General Hospital, Eastbourne BN21 2UD, United Kingdom; Completed

Royal Liverpool University Hospital, Prescot Street, Liverpool L7 8XP, United Kingdom; Completed

Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London EC1M 6BQ, United Kingdom; Completed

Southend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff on Sea SS0 0RY, United Kingdom; Completed

Arizona Center for Cancer Care, Glendale, Arizona 85306, United States; Completed

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

Marin Oncology Associates, Greenbrae, California 94904-2007, United States; Completed

Wilshire Oncology Medical Group, Inc, La Verne, California 91750, United States; Completed

North County Hematology Oncology (NCHO) - TRM, LLC., Oceanside, California 92056, United States; Completed

Hematology-Oncology Medical Group of Orange County, Inc., Orange, California 92868, United States; Completed

Central Coast Medical Oncology Corporation, Santa Maria, California 93454, United States; Completed

Wellness Hematology Oncology, West Hills, California 92056, United States; Completed

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

Illinois Cancer Care, P.C., Peoria, Illinois 61615, United States; Recruiting

LRG Healthcare Oncology Clinic, Laconia, Indiana 03246, United States; Recruiting

Iowa Oncology Research Association, Des Moines, Iowa 50309, United States; Recruiting

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting

Coborn Cancer Center at the St. Cloud Hospital, Saint Cloud, Minnesota 56303, United States; Recruiting

NH Oncology - Hematology, PA, Hooksett, New Hampshire 03106, United States; Recruiting

Hematology-Oncology Associates of Northern NJ, Morristown, New Jersey 07962, United States; Recruiting

Weill Cornell Medical College, New York, New York 10065, United States; Recruiting

SUNY Upstate Medical University, Syracuse, New York 13210, United States; Recruiting

Wake Forest Baptist Health, Winston-Salem, North Carolina 27157, United States; Recruiting

Providence Portland Medical Center, Portland, Oregon 97213, United States; Recruiting

Associacao Hospitalar Moinhos de Vento/ Hospital Moinhos de Vento, Porto Alegre, Rio Grande do Sul 90035-001, Brazil; Recruiting

Associaçao Educudora São Carlos AESC/Hospital Giovanni Battista HGB( Hospital Mae de Deus Center), Porto Alegre, Rio Grande do Sul 90740-340, Brazil; Recruiting

Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul 90035-903, Brazil; Recruiting

União Brasileira de Educação e Assistência/ Hospital São Lucas da PUCRS, Porto Alegre, Rio Grande do Sul 90610-000, Brazil; Recruiting

Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute, Spartanburg, South Carolina 29303, United States; Recruiting

Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos, São Paulo 14784-400, Brazil; Recruiting

Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú, Jau/SP, São Paulo 17210-080, Brazil; Recruiting

Additional Information

Starting date: November 2013
Last updated: May 6, 2015

Page last updated: August 23, 2015

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