Phase
Condition
Lymphoma
Treatment
Lenalidomide
Placebo
Rituximab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 studyrelated 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 orchemoimmunotherapy and have received at least 2 previous doses of rituximab.
- Documented relapsed, refractory or progressive disease after treatment with systemictherapy and must not be rituximab-refractory.
- Investigator considers rituximab monotherapy appropriate.
- Bi-dimensionally measurable disease on cross sectional imaging by X-ray computedtomography (CT) or magnetic resonance imaging (MRI).
- Need of treatment for relapsed, progressed or refractory disease as assessed by theinvestigator.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Adequate bone marrow function.
- Willingness to follow study visit schedule, pregnancy precautions and other protocolrequirements.
Exclusion
Exclusion Criteria:
- Histology other than follicular or marginal zone lymphoma or clinical evidence oftransformation or Grade 3b follicular lymphoma.
- Subjects taking corticosteroids during the last week prior to study treatment, unlessadministered 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 weeksuse of radioimmunotherapy within 6 months.
- Known seropositive for or active viral infection with hepatitis B virus (HBV) or/andhuman immunodeficiency virus (HIV).
- Known hepatitis C virus (HCV) positive with chronic HCV or active viral infection withHCV 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, unlessthe 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 takeprophylaxis for it.
- Uncontrolled intercurrent illness.
- Any significant medical condition, laboratory abnormality, or psychiatric illness thatwould 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 toparticipate in the study or that confounds the ability to interpret data from thestudy.
Study Design
Study Description
Connect with a study center
AZ St-Jan Brugge Oostende AV
Brugge, 8000
BelgiumSite Not Available
Local Institution - 371
Gent, 9000
BelgiumSite Not Available
UZ Gent
Gent, 9000
BelgiumSite Not Available
AZ Groeninge
Kortrijk, 8500
BelgiumSite Not Available
CHU Mont -Godinne
Yvoir, 5530
BelgiumSite Not Available
Associacao Educudora Sao Carlos AESC Hospital Giovanni Battista HGB Hospital Mae de Deus Center
Porto Alegre, Rio Grande Do Sul 90740-340
BrazilSite Not Available
Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento
Porto Alegre, Rio Grande Do Sul 90035-001
BrazilSite Not Available
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90035-903
BrazilSite Not Available
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande Do Sul 90610-000
BrazilSite Not Available
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo 14784-400
BrazilSite Not Available
Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú
Jau/SP, São Paulo 17210-080
BrazilSite Not Available
Hospital Sírio Libanês
Brasilia, 28031
BrazilSite Not Available
Oncotek - Clinica de Tratamento e Pesquisa Oncológica
Brasília, 70390-055
BrazilSite Not Available
Hospital Amaral Carvalho
Jaú, 17210 120
BrazilSite Not Available
Pro Onco Centro de Tratamento Oncológico
Londrina, 86050-190
BrazilSite Not Available
MS INCA HC I Hospital do Cancer I
Rio De Janeiro, 20231-130
BrazilSite Not Available
INCA - Instituto Nacional de Câncer José Alencar Gomes da Silva
Rio de Janeiro (RJ), 20231-050
BrazilSite Not Available
Fundacao Antonio Prudente - Hospital AC Camargo
Sao Paulo, 01509-900
BrazilSite Not Available
Fundação Antonio Prudente - AC Camargo Câncer center
São Paulo, 01509-900
BrazilSite Not Available
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01321-001
BrazilSite Not Available
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, 01308 050
BrazilSite Not Available
Hospital Sirio Libanes
São Paulo - SP, 01308 050
BrazilSite Not Available
307 Hospital of PLA
Beijing, 100071
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing, 100730
ChinaSite Not Available
Peking University People's Hospital
Beijing, 100044
ChinaSite Not Available
Beijing Cancer Hospital
Beijing, PR, 100142
ChinaSite Not Available
The Third Xiangya hospital of central south university
Changsha, 410013
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, 610041
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu Sichuan, 610041
ChinaSite Not Available
Fujian Medical University Union Hospital
Fujian, 350001
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou, 350001
ChinaSite Not Available
Guangdong General Hospital
Guangzhou, 510080
ChinaSite Not Available
Local Institution - 600
Guangzhou, 510080
ChinaSite Not Available
Sun Yat-sen University Cancer Center
Guangzhou, 510060
ChinaSite Not Available
"The First Affiliated Hospital of Medical School of Zhejiang University/ First Hospital of Zhejiang Province
Hangzhou, 310003
ChinaSite Not Available
Local Institution - 604
Hangzhou City, 310006
ChinaSite Not Available
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou City, 310003
ChinaSite Not Available
Jiangsu Province Hospital/ The First Hospital affiliated with Nanjing Medical University
Jiangsu, 210029
ChinaSite Not Available
Jiangsu Province Hospital The First Hospital affiliated with Nanjing Medical University
Nanjing, 210029
ChinaSite Not Available
Cancer Hospital, Fudan University
Shanghai, 200032
ChinaSite Not Available
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai,
ChinaSite Not Available
Xijing Hospital
Shanxi, 710032
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou, 215006
ChinaSite Not Available
Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, 300020
ChinaSite Not Available
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
ChinaSite Not Available
Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
Tianjn, 300041
ChinaSite Not Available
Xijing Hospital
Xi'an, 710032
ChinaSite Not Available
Fakultni nemocnice Ostrava
Ostrava-Poruba, 708 52
Czech RepublicSite Not Available
Medical Clinical Charles University Hospital
Prague 2, 12808
Czech RepublicSite Not Available
Fakultni nemocnice Kralovske Vinohrady
Praha 10, 100 34 Praha 10
Czech RepublicSite Not Available
Interni hematoonkologicka klinika
Brno, 625 00
CzechiaSite Not Available
Fakultni nemocnice Hradec Kralove, IV.interni hematologicka klinika
Hradec Kralove, 500 05
CzechiaSite Not Available
Fakultni Nemocnice Ostrava, Klinika hematoonkologie,
Ostrava, 70852
CzechiaSite Not Available
Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika
Prague 10, 100 34
CzechiaSite Not Available
Local Institution - 534
Praha, 128 08
CzechiaSite Not Available
Vseobecna Fakultni Nemocnice v Praze
Praha, 128 08
CzechiaSite Not Available
CHU d'Angers
Angers, 49033
FranceSite Not Available
Centre Hospitalier Universitaire d'Avicennes
Bobigny Cedex, 93009
FranceSite Not Available
Hôpital A Morvan
Brest, 29609
FranceSite Not Available
CHRU de Brest - Hopital Morvan
Brest Cedex, 29609
FranceSite Not Available
Hopital Saint-Louis
Paris, 75010
FranceSite Not Available
CH Perpignan - Hopital Saint-Jean
Perpignan, 66046
FranceSite Not Available
CHU de Poitiers
Poitiers, 86021
FranceSite Not Available
Centre Hospitalier de Valence
Valence, 26953
FranceSite Not Available
Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum
Berlin, 13353
GermanySite Not Available
Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin
Berlin, 12203
GermanySite Not Available
Krankenhaus Nordwest
Frankfurt, 60488
GermanySite Not Available
Krankenhaus Nordwest
Frankfurt a.M., 60488
GermanySite Not Available
Onkologische Schwerpunktpraxis Leer - Emden
Leer, 26789
GermanySite Not Available
Kliniken Maria Hilf GmbH
Mönchengladbach, 41063
GermanySite Not Available
Schwarzwald Baar Klinikum
Villingen, 78052
GermanySite Not Available
Klinkum der Stadt Villingen-Schwenningen GmbH
Villingen-Schwenningen, 78052
GermanySite Not Available
Soroka University Medical Center
Beer Sheva, 84101
IsraelSite Not Available
Hadassah University Hospital
Jerusalem, 91120
IsraelSite Not Available
Rabin Medical Center
Petach Tikva, 49100
IsraelSite Not Available
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
IsraelSite Not Available
Tel-Aviv Sourasky Medical Center
Tel-Aviv, 64239
IsraelSite Not Available
Centro di Riferimento Oncologico - Aviano
Aviano, 33081
ItalySite Not Available
Centro di Riferimento Oncologico - IRCCS
Aviano (PN), 33081
ItalySite Not Available
U.O.C. Ematologia
Barletta, 76121
ItalySite Not Available
A.O.U. di Bologna Policlinico S.Orsola-Malpighi
Bologna, 40138
ItalySite Not Available
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Nesima
Catania, 95124
ItalySite Not Available
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
Meldola, 47014
ItalySite Not Available
Istituto Europeo di Oncologia - IEO
Milano, 20141
ItalySite Not Available
Ospedale Niguarda Ca Granda
Milano, 20162
ItalySite Not Available
IRCCS- Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione "G. Pascale"
Napoli, 80131
ItalySite Not Available
Az. Osp. Vincenzo Cervello
Palermo, 90146
ItalySite Not Available
Casa di Cura La Maddalena
Palermo, 90146
ItalySite Not Available
Azienda Ospedaliero-Universitaria di Parma
Parma, 43100
ItalySite Not Available
Ospedale di Ravenna
Ravenna, 48121
ItalySite Not Available
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria, 89100
ItalySite Not Available
Ospedale degli Infermi di Rimini
Rimini, 47900
ItalySite Not Available
Azienda Ospedaliera S. Andrea - Università La Sapienza
Roma, 00189
ItalySite Not Available
Local Institution - 340
Roma, 00189
ItalySite Not Available
Local Institution - 708
Nagasaki-shi, Nagasaki 852-8511
JapanSite Not Available
Local Institution - 709
Minato-ku, Tokyo 105-8470
JapanSite Not Available
National Cancer Center Hospital
Chuo-ku, 104-0045
JapanSite Not Available
Chugoku Central Hospital
Hiroshima, 7200001
JapanSite Not Available
National Cancer Center Hospital East
Kashiwa, 277-8577
JapanSite Not Available
Kobe City Medical Center General Hospital
Kobe-city, 650-0047
JapanSite Not Available
Local Institution - 700
Koto-ku, 1350063
JapanSite Not Available
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Koto-ku, 135-8550
JapanSite Not Available
University Hospital, Kyoto Prefectural University of Medicine
Kyoto-city, 602-8566
JapanSite Not Available
Toranomon Hospital
Minato-ku, 105-8470
JapanSite Not Available
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, 852-8511
JapanSite Not Available
Nagoya Medical Center,Division of Hematology/Oncology
Nagoya, 460-0001
JapanSite Not Available
National University Corporation Tohoku University, Tohoku University Hospital
Sendai-shi, 980-8574
JapanSite Not Available
The cancer Institute Hospital of JFCR
Tokyo, 135-8550
JapanSite Not Available
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
PolandSite Not Available
Malopolskie Centrum Medyczne
Krakow, 30-510
PolandSite Not Available
Malopolskie Centrum Medyczne S.C.
Kraków, 30-510
PolandSite Not Available
Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie
Warszawa, 02-781
PolandSite Not Available
Instytut Hematologii i Transfuzjologii w Warszawie
Warszawa, 02-776
PolandSite Not Available
Local Institution - 513
Warszawa, 02-781
PolandSite Not Available
Local Institution - 514
Warszawa, 02-776
PolandSite Not Available
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil
Lisboa, 1099-023
PortugalSite Not Available
Local Institution - 330
Lisboa, 1099-023
PortugalSite Not Available
Instituto Portugues de Oncologia do Porto, Francisco Gentil
Porto, 4200-072
PortugalSite Not Available
Local Institution - 331
Porto, 4200-072
PortugalSite Not Available
Hospital Auxilio Muto Centro de Cancer
San Juan, 00918
Puerto RicoSite Not Available
Krasnoyarsk Regional Clinical Hospital
Krasnoyarsk, 660022
Russian FederationSite Not Available
Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin
Moscow, 125101
Russian FederationSite Not Available
Russian Academy of Medical Sciences Institution
Moscow, 115478
Russian FederationSite Not Available
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
St Petersburg, 197341
Russian FederationSite Not Available
State Educational Institution of High Professional Education "Saint Petersburg State Medical University of RosZdrav named after academician I.I.
St. Petersburg, 197022
Russian FederationSite Not Available
St. Petersburg Pavlov State Medical University
St.Petersburg, 197022
Russian FederationSite Not Available
The Ministry of Health and Social Development of the Tula region state institution Health Tula regio
Tula, 300053
Russian FederationSite Not Available
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
SpainSite Not Available
Hospital Universitario Reina Sofia
Cordoba, 14004
SpainSite Not Available
Hospital Universitario Reina Sofia
Córdoba, 14004
SpainSite Not Available
Local Institution - 314
Córdoba, 14004
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
SpainSite Not Available
Hospital Universitario Infanta Leonor
Madrid, 28031
SpainSite Not Available
Hospital Costa del Sol
Marbella, 29603
SpainSite Not Available
Local Institution - 315
Marbella, 29603
SpainSite Not Available
Hospital Morales Meseguer
Murcia, 30008
SpainSite Not Available
Local Institution - 318
Murcia, 30008
SpainSite Not Available
Hospital Universitario de Salamanca
Salamanca, 37007
SpainSite Not Available
Local Institution - 311
Salamanca, 37007
SpainSite Not Available
Hospital Universitario Virgen Del Rocio
Sevilla, 41013
SpainSite Not Available
Cukurova University Medical Faculty Balcali Hospital
Adana, 01330
TurkeySite Not Available
Hacettepe Universitesi
Ankara, 06100
TurkeySite Not Available
Pamukkale University Medical Faculty
Denizli, 20070
TurkeySite Not Available
Gaziantep University
Gaziantep, 27310
TurkeySite Not Available
Marmara University
Istanbul, 34840
TurkeySite Not Available
Dokuz Eylul University Izmir
Izmir, 35340
TurkeySite Not Available
19 Mayis Medical Faculty - Samsun
Samsun, 55139
TurkeySite Not Available
Kocaeli Derince Training and Research Hospital
Umuttepe Kocaeli, 41380
TurkeySite Not Available
Dorset County Hopsital, Dorchester
Dorchester, DT1 2JY
United KingdomSite Not Available
Conquest and Eastbourne Hospitals
East Sussex, TN37 7RD
United KingdomSite Not Available
Eastbourne District General Hospital
Eastbourne, BN21 2UD
United KingdomSite Not Available
Royal Liverpool University Hospital, Prescot Street
Liverpool, L7 8XP
United KingdomSite Not Available
Barts Cancer Institute, Queen Mary University of London, Charterhouse Square
London, EC1M 6BQ
United KingdomSite Not Available
Southend University Hospital NHS Foundation Trust, Prittlewell Chase
Westcliff on Sea, SS0 0RY
United KingdomSite Not Available
Mitchell Cancer Center, University of South Alabama
Mobile, Alabama 36604
United StatesSite Not Available
Arizona Center for Cancer Care
Glendale, Arizona 85306
United StatesSite Not Available
Southwest Cancer Care Medical Group
Escondido, California 92025
United StatesSite Not Available
Marin Oncology Associates
Greenbrae, California 94904-2007
United StatesSite Not Available
Wilshire Oncology Medical Group, Inc
La Verne, California 91750
United StatesSite Not Available
North County Hematology Oncology (NCHO) - TRM, LLC.
Oceanside, California 92056
United StatesSite Not Available
Hematology-Oncology Medical Group of Orange County, Inc.
Orange, California 92868
United StatesSite Not Available
UC Davis Medical Center
Sacramento, California 95817
United StatesSite Not Available
Central Coast Medical Oncology Corporation
Santa Maria, California 93454
United StatesSite Not Available
Wellness Hematology Oncology
West Hills, California 92056
United StatesSite Not Available
Cancer Center of Central Connecticut
Southington, Connecticut 06489
United StatesSite Not Available
Florida Cancer Specialists North Region Sarah Cannon Research
Saint Petersburg, Florida 33705
United StatesSite Not Available
Illinois Cancer Care, P.C.
Peoria, Illinois 61615
United StatesSite Not Available
LRG Healthcare Oncology Clinic
Laconia, Indiana 03246
United StatesSite Not Available
Northern Indiana Cancer Research Consortium
South Bend, Indiana 46628
United StatesSite Not Available
Iowa Oncology Research Association
Des Moines, Iowa 50309
United StatesSite Not Available
University of Louisville, J.G. Brown Cancer Center
Louisville, Kentucky 40202
United StatesSite Not Available
Providence Cancer Institute
Southfield, Michigan 48075
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Coborn Cancer Center at the St. Cloud Hospital
Saint Cloud, Minnesota 56303
United StatesSite Not Available
Coborn Cancer Center
St. Cloud, Minnesota 56303
United StatesSite Not Available
New Hampshire Oncology-Hematology P.A
Concord, New Hampshire 03301
United StatesSite Not Available
NH Oncology - Hematology, PA
Hooksett, New Hampshire 03106
United StatesSite Not Available
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Hematology-Oncology Associates of Northern NJ
Morristown, New Jersey 07962
United StatesSite Not Available
University of New Mexico
Albuquerque, New Mexico 87102
United StatesSite Not Available
Weill Cornell Medical College
New York, New York 10065
United StatesSite Not Available
SUNY Upstate Medical University
Syracuse, New York 13210
United StatesSite Not Available
Wake Forest University Health Services
Winston Salem, North Carolina 27157
United StatesSite Not Available
Wake Forest Baptist Health
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Oncology Hematology Care Sarah Cannon Research
Cincinnati, Ohio 45242
United StatesSite Not Available
Local Institution - 028
Portland, Oregon 97213
United StatesSite Not Available
Providence Portland Medical Center
Portland, Oregon 97213
United StatesSite Not Available
St Francis Hospital
Greenville, South Carolina 29607
United StatesSite Not Available
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina 29303
United StatesSite Not Available
Sarah Cannon Research Inst
Nashville, Tennessee 37203
United StatesSite Not Available
Arlington Cancer Center
Arlington, Texas 76012
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Northwest Medical Specialties PLLC
Tacoma, Washington 98405
United StatesSite Not Available
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