Non Hodgkin Lymphoma Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years at the time of signing the informed consent document.
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1, 2 or 3a; CD20+ by flow cytometry or histochemistry).
Previously treated with at least one prior systemic chemotherapy, immunotherapy or chemoimmunotherapy and have received at least 2 previous doses of rituximab.
Documented relapsed, refractory or progressive disease after treatment with systemic therapy and must not be rituximab-refractory.
Investigator considers rituximab monotherapy appropriate.
Bi-dimensionally measurable disease on cross sectional imaging by X-ray computed tomography (CT) or magnetic resonance imaging (MRI).
Need of treatment for relapsed, progressed or refractory disease as assessed by the investigator.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Adequate bone marrow function.
Willingness to follow study visit schedule, pregnancy precautions and other protocol requirements.

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 prior to study treatment, 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) or/and human immunodeficiency virus (HIV).
Known hepatitis C virus (HCV) positive with chronic HCV or active viral infection with HCV hepatitis requiring anti-viral medication (at time of randomization).
Life expectancy < 6 months.
Known sensitivity or allergy to murine products.
Prior history of malignancies, other than follicular or marginal zone lymphoma, unless the subject has been free of the disease for ≥ 5 years.
Prior use of lenalidomide.
Known allergy to thalidomide.
Neuropathy > Grade 1.
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.
Uncontrolled intercurrent illness.
Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document.
Pregnant or lactating females.
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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

358

Study ID:

NCT01938001

Recruitment Status:

Completed

Sponsor:

Celgene

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There are 139 Locations for this study

See Locations Near You

Mitchell Cancer Center, University of South Alabama
Mobile Alabama, 36604, United States
Arizona Center for Cancer Care
Glendale Arizona, 85306, United States
Southwest Cancer Care Medical Group
Escondido California, 92025, United States
Marin Oncology Associates
Greenbrae California, 94904, United States
Wilshire Oncology Medical Group, Inc
La Verne California, 91750, United States
North County Hematology Oncology (NCHO) - TRM, LLC.
Oceanside California, 92056, United States
Hematology-Oncology Medical Group of Orange County, Inc.
Orange California, 92868, United States
UC Davis Medical Center
Sacramento California, 95817, United States
Central Coast Medical Oncology Corporation
Santa Maria California, 93454, United States
Wellness Hematology Oncology
West Hills California, 92056, United States
Cancer Center of Central Connecticut
Southington Connecticut, 06489, United States
Florida Cancer Specialists North Region Sarah Cannon Research
Saint Petersburg Florida, 33705, United States
Illinois Cancer Care, P.C.
Peoria Illinois, 61615, United States
LRG Healthcare Oncology Clinic
Laconia Indiana, 03246, United States
Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
University of Louisville, J.G. Brown Cancer Center
Louisville Kentucky, 40202, United States
Providence Cancer Institute
Southfield Michigan, 48075, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Coborn Cancer Center at the St. Cloud Hospital
Saint Cloud Minnesota, 56303, United States
NH Oncology - Hematology, PA
Hooksett New Hampshire, 03106, United States
The Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Hematology-Oncology Associates of Northern NJ
Morristown New Jersey, 07962, United States
University of New Mexico
Albuquerque New Mexico, 87102, United States
Weill Cornell Medical College
New York New York, 10065, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States
Oncology Hematology Care Sarah Cannon Research
Cincinnati Ohio, 45242, United States
Local Institution - 028
Portland Oregon, 97213, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
St Francis Hospital
Greenville South Carolina, 29607, United States
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
Spartanburg South Carolina, 29303, United States
Sarah Cannon Research Inst
Nashville Tennessee, 37203, United States
Arlington Cancer Center
Arlington Texas, 76012, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Northwest Medical Specialties PLLC
Tacoma Washington, 98405, United States
AZ St-Jan Brugge Oostende AV
Brugge , 8000, Belgium
Local Institution - 371
Gent , 9000, Belgium
UZ Gent
Gent , 9000, Belgium
AZ Groeninge
Kortrijk , 8500, Belgium
CHU Mont -Godinne
Yvoir , 5530, Belgium
Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Associacao Educudora Sao Carlos AESC Hospital Giovanni Battista HGB Hospital Mae de Deus Center
Porto Alegre Rio Grande Do Sul, 90740, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos São Paulo, 14784, Brazil
Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú
Jau/SP São Paulo, 17210, Brazil
MS INCA HC I Hospital do Cancer I
Rio De Janeiro , 20231, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo , 01308, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo , 01321, Brazil
Fundação Antonio Prudente - AC Camargo Câncer center
São Paulo , 01509, Brazil
Beijing Cancer Hospital
Beijing, PR , 10014, China
Peking University People's Hospital
Beijing , 10004, China
307 Hospital of PLA
Beijing , 10007, China
Peking Union Medical College Hospital
Beijing , 10073, China
The Third Xiangya hospital of central south university
Changsha , 41001, China
West China Hospital of Sichuan University
Chengdu , 61004, China
Fujian Medical University Union Hospital
Fuzhou , 35000, China
Sun Yat-sen University Cancer Center
Guangzhou , 51006, China
Guangdong General Hospital
Guangzhou , 51008, China
Local Institution - 600
Guangzhou , 51008, China
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou City , 31000, China
Local Institution - 604
Hangzhou City , 31000, China
Jiangsu Province Hospital The First Hospital affiliated with Nanjing Medical University
Nanjing , 21002, China
Cancer Hospital, Fudan University
Shanghai , 20003, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai , , China
The First Affiliated Hospital of Soochow University
Suzhou , 21500, China
Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin , 30002, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin , 30006, China
Xijing Hospital
Xi'an , 71003, China
Interni hematoonkologicka klinika
Brno , 625 0, Czechia
Fakultni nemocnice Hradec Kralove, IV.interni hematologicka klinika
Hradec Kralove , 500 0, Czechia
Fakultni Nemocnice Ostrava, Klinika hematoonkologie,
Ostrava , 70852, Czechia
Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika
Prague 10 , 100 3, Czechia
Local Institution - 534
Praha , 128 0, Czechia
Vseobecna Fakultni Nemocnice v Praze
Praha , 128 0, Czechia
CHU d'Angers
Angers , 49033, France
Centre Hospitalier Universitaire d'Avicennes
Bobigny Cedex , 93009, France
CHRU de Brest - Hopital Morvan
Brest Cedex , 29609, France
Hopital Saint-Louis
Paris , 75010, France
CH Perpignan - Hopital Saint-Jean
Perpignan , 66046, France
CHU de Poitiers
Poitiers , 86021, France
Centre Hospitalier de Valence
Valence , 26953, France
Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin
Berlin , 12203, Germany
Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum
Berlin , 13353, Germany
Krankenhaus Nordwest
Frankfurt , 60488, Germany
Onkologische Schwerpunktpraxis Leer - Emden
Leer , 26789, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach , 41063, Germany
Klinkum der Stadt Villingen-Schwenningen GmbH
Villingen-Schwenningen , 78052, Germany
Soroka University Medical Center
Beer Sheva , 84101, Israel
Hadassah University Hospital
Jerusalem , 91120, Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv , 64239, Israel
Centro di Riferimento Oncologico - IRCCS
Aviano (PN) , 33081, Italy
U.O.C. Ematologia
Barletta , 76121, Italy
A.O.U. di Bologna Policlinico S.Orsola-Malpighi
Bologna , 40138, Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Nesima
Catania , 95124, Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
Meldola , 47014, Italy
Istituto Europeo di Oncologia - IEO
Milano , 20141, Italy
Ospedale Niguarda Ca Granda
Milano , 20162, Italy
IRCCS- Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione "G. Pascale"
Napoli , 80131, Italy
Az. Osp. Vincenzo Cervello
Palermo , 90146, Italy
Casa di Cura La Maddalena
Palermo , 90146, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma , 43100, Italy
Ospedale di Ravenna
Ravenna , 48121, Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria , 89100, Italy
Ospedale degli Infermi di Rimini
Rimini , 47900, Italy
Azienda Ospedaliera S. Andrea - Università La Sapienza
Roma , 00189, Italy
Local Institution - 340
Roma , 00189, Italy
Local Institution - 708
Nagasaki-shi Nagasaki, 852-8, Japan
National Cancer Center Hospital
Chuo-ku , 104-0, Japan
Chugoku Central Hospital
Hiroshima , 72000, Japan
National Cancer Center Hospital East
Kashiwa , 277-8, Japan
Kobe City Medical Center General Hospital
Kobe-city , 650-0, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Koto-ku , 135-8, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto-city , 602-8, Japan
Toranomon Hospital
Minato-ku , 105-8, Japan
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki , 852-8, Japan
Nagoya Medical Center,Division of Hematology/Oncology
Nagoya , 460-0, Japan
National University Corporation Tohoku University, Tohoku University Hospital
Sendai-shi , 980-8, Japan
Malopolskie Centrum Medyczne S.C.
Kraków , 30-51, Poland
Instytut Hematologii i Transfuzjologii w Warszawie
Warszawa , 02-77, Poland
Local Institution - 514
Warszawa , 02-77, Poland
Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie
Warszawa , 02-78, Poland
Local Institution - 513
Warszawa , 02-78, Poland
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil
Lisboa , 1099-, Portugal
Local Institution - 330
Lisboa , 1099-, Portugal
Instituto Portugues de Oncologia do Porto, Francisco Gentil
Porto , 4200-, Portugal
Local Institution - 331
Porto , 4200-, Portugal
Hospital Auxilio Muto Centro de Cancer
San Juan , 00918, Puerto Rico
Krasnoyarsk Regional Clinical Hospital
Krasnoyarsk , 66002, Russian Federation
Russian Academy of Medical Sciences Institution
Moscow , 11547, Russian Federation
Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin
Moscow , 12510, Russian Federation
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
St Petersburg , 19734, Russian Federation
St. Petersburg Pavlov State Medical University
St.Petersburg , 19702, Russian Federation
The Ministry of Health and Social Development of the Tula region state institution Health Tula regio
Tula , 30005, Russian Federation
Hospital de la Santa Creu i Sant Pau
Barcelona , 08041, Spain
Hospital Universitario Reina Sofia
Córdoba , 14004, Spain
Local Institution - 314
Córdoba , 14004, Spain
Hospital Universitario Infanta Leonor
Madrid , 28031, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Costa del Sol
Marbella , 29603, Spain
Local Institution - 315
Marbella , 29603, Spain
Hospital Morales Meseguer
Murcia , 30008, Spain
Local Institution - 318
Murcia , 30008, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Local Institution - 311
Salamanca , 37007, Spain
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain
Cukurova University Medical Faculty Balcali Hospital
Adana , 01330, Turkey
Hacettepe Universitesi
Ankara , 06100, Turkey
Pamukkale University Medical Faculty
Denizli , 20070, Turkey
Gaziantep University
Gaziantep , 27310, Turkey
Marmara University
Istanbul , 34840, Turkey
Dokuz Eylul University Izmir
Izmir , 35340, Turkey
19 Mayis Medical Faculty - Samsun
Samsun , 55139, Turkey
Kocaeli Derince Training and Research Hospital
Umuttepe Kocaeli , 41380, Turkey
Eastbourne District General Hospital
Eastbourne , BN21 , United Kingdom
Royal Liverpool University Hospital, Prescot Street
Liverpool , L7 8X, United Kingdom
Barts Cancer Institute, Queen Mary University of London, Charterhouse Square
London , EC1M , United Kingdom
Southend University Hospital NHS Foundation Trust, Prittlewell Chase
Westcliff on Sea , SS0 0, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

358

Study ID:

NCT01938001

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

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