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

Last updated: January 26, 2023
Sponsor: Celgene
Overall Status: Completed

Phase

3

Condition

Lymphoma

Treatment

Lenalidomide

Placebo

Rituximab

Clinical Study ID

NCT01938001
CC-5013-NHL-007
  • Ages > 18
  • All Genders

Study 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.

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

Total Participants: 358
Treatment Group(s): 3
Primary Treatment: Lenalidomide
Phase: 3
Study Start date:
November 21, 2013
Estimated Completion Date:
January 26, 2022

Study 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.

Connect with a study center

  • AZ St-Jan Brugge Oostende AV

    Brugge, 8000
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    Site Not Available

  • Local Institution - 371

    Gent, 9000
    Belgium

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  • UZ Gent

    Gent, 9000
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  • AZ Groeninge

    Kortrijk, 8500
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  • CHU Mont -Godinne

    Yvoir, 5530
    Belgium

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  • Associacao Educudora Sao Carlos AESC Hospital Giovanni Battista HGB Hospital Mae de Deus Center

    Porto Alegre, Rio Grande Do Sul 90740-340
    Brazil

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  • Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento

    Porto Alegre, Rio Grande Do Sul 90035-001
    Brazil

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  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Site Not Available

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Site Not Available

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, São Paulo 14784-400
    Brazil

    Site Not Available

  • Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú

    Jau/SP, São Paulo 17210-080
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    Site Not Available

  • Hospital Sírio Libanês

    Brasilia, 28031
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  • Oncotek - Clinica de Tratamento e Pesquisa Oncológica

    Brasília, 70390-055
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  • Hospital Amaral Carvalho

    Jaú, 17210 120
    Brazil

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  • Pro Onco Centro de Tratamento Oncológico

    Londrina, 86050-190
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  • MS INCA HC I Hospital do Cancer I

    Rio De Janeiro, 20231-130
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  • INCA - Instituto Nacional de Câncer José Alencar Gomes da Silva

    Rio de Janeiro (RJ), 20231-050
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  • Fundacao Antonio Prudente - Hospital AC Camargo

    Sao Paulo, 01509-900
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  • Fundação Antonio Prudente - AC Camargo Câncer center

    São Paulo, 01509-900
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    São Paulo, 01321-001
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    São Paulo, 01308 050
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  • Hospital Sirio Libanes

    São Paulo - SP, 01308 050
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    Beijing, 100071
    China

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  • Peking Union Medical College Hospital

    Beijing, 100730
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    Beijing, 100044
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    Beijing, PR, 100142
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    Changsha, 410013
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    Chengdu, 610041
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    Chengdu Sichuan, 610041
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    Fujian, 350001
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    Fuzhou, 350001
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    Guangzhou, 510080
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    Guangzhou, 510060
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    Hangzhou, 310003
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    Hangzhou City, 310006
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    Jiangsu, 210029
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    Nanjing, 210029
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  • Cancer Hospital, Fudan University

    Shanghai, 200032
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  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai,
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  • Xijing Hospital

    Shanxi, 710032
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  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006
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    Tianjin, 300020
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    Tianjin, 300060
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    Tianjn, 300041
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  • Xijing Hospital

    Xi'an, 710032
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  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52
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    Prague 2, 12808
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  • Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 100 34 Praha 10
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  • Interni hematoonkologicka klinika

    Brno, 625 00
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  • Fakultni nemocnice Hradec Kralove, IV.interni hematologicka klinika

    Hradec Kralove, 500 05
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  • Fakultni Nemocnice Ostrava, Klinika hematoonkologie,

    Ostrava, 70852
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    Prague 10, 100 34
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    Praha, 128 08
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  • Vseobecna Fakultni Nemocnice v Praze

    Praha, 128 08
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  • CHU d'Angers

    Angers, 49033
    France

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  • Centre Hospitalier Universitaire d'Avicennes

    Bobigny Cedex, 93009
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  • Hôpital A Morvan

    Brest, 29609
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    Brest Cedex, 29609
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    Paris, 75010
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    Perpignan, 66046
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    Poitiers, 86021
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  • Centre Hospitalier de Valence

    Valence, 26953
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  • Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum

    Berlin, 13353
    Germany

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    Berlin, 12203
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  • Krankenhaus Nordwest

    Frankfurt, 60488
    Germany

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    Frankfurt a.M., 60488
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  • Onkologische Schwerpunktpraxis Leer - Emden

    Leer, 26789
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    Mönchengladbach, 41063
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  • Schwarzwald Baar Klinikum

    Villingen, 78052
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  • Klinkum der Stadt Villingen-Schwenningen GmbH

    Villingen-Schwenningen, 78052
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  • Soroka University Medical Center

    Beer Sheva, 84101
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  • Hadassah University Hospital

    Jerusalem, 91120
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  • Rabin Medical Center

    Petach Tikva, 49100
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  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
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  • Tel-Aviv Sourasky Medical Center

    Tel-Aviv, 64239
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    Aviano, 33081
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  • Centro di Riferimento Oncologico - IRCCS

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  • A.O.U. di Bologna Policlinico S.Orsola-Malpighi

    Bologna, 40138
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  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Nesima

    Catania, 95124
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  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

    Meldola, 47014
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  • Istituto Europeo di Oncologia - IEO

    Milano, 20141
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  • Ospedale Niguarda Ca Granda

    Milano, 20162
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  • IRCCS- Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione "G. Pascale"

    Napoli, 80131
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    Site Not Available

  • Az. Osp. Vincenzo Cervello

    Palermo, 90146
    Italy

    Site Not Available

  • Casa di Cura La Maddalena

    Palermo, 90146
    Italy

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  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43100
    Italy

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  • Ospedale di Ravenna

    Ravenna, 48121
    Italy

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  • Azienda Ospedaliera Bianchi-Melacrino-Morelli

    Reggio Calabria, 89100
    Italy

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  • Ospedale degli Infermi di Rimini

    Rimini, 47900
    Italy

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  • Azienda Ospedaliera S. Andrea - Università La Sapienza

    Roma, 00189
    Italy

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  • Local Institution - 340

    Roma, 00189
    Italy

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  • Local Institution - 708

    Nagasaki-shi, Nagasaki 852-8511
    Japan

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  • Local Institution - 709

    Minato-ku, Tokyo 105-8470
    Japan

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  • National Cancer Center Hospital

    Chuo-ku, 104-0045
    Japan

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  • Chugoku Central Hospital

    Hiroshima, 7200001
    Japan

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  • National Cancer Center Hospital East

    Kashiwa, 277-8577
    Japan

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  • Kobe City Medical Center General Hospital

    Kobe-city, 650-0047
    Japan

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  • Local Institution - 700

    Koto-ku, 1350063
    Japan

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  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research

    Koto-ku, 135-8550
    Japan

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  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto-city, 602-8566
    Japan

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  • Toranomon Hospital

    Minato-ku, 105-8470
    Japan

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  • The Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, 852-8511
    Japan

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  • Nagoya Medical Center,Division of Hematology/Oncology

    Nagoya, 460-0001
    Japan

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  • National University Corporation Tohoku University, Tohoku University Hospital

    Sendai-shi, 980-8574
    Japan

    Site Not Available

  • The cancer Institute Hospital of JFCR

    Tokyo, 135-8550
    Japan

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952
    Poland

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  • Malopolskie Centrum Medyczne

    Krakow, 30-510
    Poland

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  • Malopolskie Centrum Medyczne S.C.

    Kraków, 30-510
    Poland

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  • Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie

    Warszawa, 02-781
    Poland

    Site Not Available

  • Instytut Hematologii i Transfuzjologii w Warszawie

    Warszawa, 02-776
    Poland

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  • Local Institution - 513

    Warszawa, 02-781
    Poland

    Site Not Available

  • Local Institution - 514

    Warszawa, 02-776
    Poland

    Site Not Available

  • Instituto Portugues de Oncologia de Lisboa, Francisco Gentil

    Lisboa, 1099-023
    Portugal

    Site Not Available

  • Local Institution - 330

    Lisboa, 1099-023
    Portugal

    Site Not Available

  • Instituto Portugues de Oncologia do Porto, Francisco Gentil

    Porto, 4200-072
    Portugal

    Site Not Available

  • Local Institution - 331

    Porto, 4200-072
    Portugal

    Site Not Available

  • Hospital Auxilio Muto Centro de Cancer

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Krasnoyarsk Regional Clinical Hospital

    Krasnoyarsk, 660022
    Russian Federation

    Site Not Available

  • Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin

    Moscow, 125101
    Russian Federation

    Site Not Available

  • Russian Academy of Medical Sciences Institution

    Moscow, 115478
    Russian Federation

    Site Not Available

  • Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

    St Petersburg, 197341
    Russian Federation

    Site 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 Federation

    Site Not Available

  • St. Petersburg Pavlov State Medical University

    St.Petersburg, 197022
    Russian Federation

    Site Not Available

  • The Ministry of Health and Social Development of the Tula region state institution Health Tula regio

    Tula, 300053
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    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

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  • Hospital Universitario Reina Sofia

    Cordoba, 14004
    Spain

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  • Hospital Universitario Reina Sofia

    Córdoba, 14004
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  • Local Institution - 314

    Córdoba, 14004
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    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
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  • Hospital Universitario Infanta Leonor

    Madrid, 28031
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  • Hospital Costa del Sol

    Marbella, 29603
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  • Local Institution - 315

    Marbella, 29603
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  • Hospital Morales Meseguer

    Murcia, 30008
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  • Local Institution - 318

    Murcia, 30008
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  • Hospital Universitario de Salamanca

    Salamanca, 37007
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  • Local Institution - 311

    Salamanca, 37007
    Spain

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  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

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  • Cukurova University Medical Faculty Balcali Hospital

    Adana, 01330
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    Site Not Available

  • Hacettepe Universitesi

    Ankara, 06100
    Turkey

    Site Not Available

  • Pamukkale University Medical Faculty

    Denizli, 20070
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  • Gaziantep University

    Gaziantep, 27310
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  • Marmara University

    Istanbul, 34840
    Turkey

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  • Dokuz Eylul University Izmir

    Izmir, 35340
    Turkey

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  • 19 Mayis Medical Faculty - Samsun

    Samsun, 55139
    Turkey

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  • Kocaeli Derince Training and Research Hospital

    Umuttepe Kocaeli, 41380
    Turkey

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  • Dorset County Hopsital, Dorchester

    Dorchester, DT1 2JY
    United Kingdom

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  • Conquest and Eastbourne Hospitals

    East Sussex, TN37 7RD
    United Kingdom

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  • Eastbourne District General Hospital

    Eastbourne, BN21 2UD
    United Kingdom

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  • Royal Liverpool University Hospital, Prescot Street

    Liverpool, L7 8XP
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  • Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

    London, EC1M 6BQ
    United Kingdom

    Site Not Available

  • Southend University Hospital NHS Foundation Trust, Prittlewell Chase

    Westcliff on Sea, SS0 0RY
    United Kingdom

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  • Mitchell Cancer Center, University of South Alabama

    Mobile, Alabama 36604
    United States

    Site Not Available

  • Arizona Center for Cancer Care

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Southwest Cancer Care Medical Group

    Escondido, California 92025
    United States

    Site Not Available

  • Marin Oncology Associates

    Greenbrae, California 94904-2007
    United States

    Site Not Available

  • Wilshire Oncology Medical Group, Inc

    La Verne, California 91750
    United States

    Site Not Available

  • North County Hematology Oncology (NCHO) - TRM, LLC.

    Oceanside, California 92056
    United States

    Site Not Available

  • Hematology-Oncology Medical Group of Orange County, Inc.

    Orange, California 92868
    United States

    Site Not Available

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Central Coast Medical Oncology Corporation

    Santa Maria, California 93454
    United States

    Site Not Available

  • Wellness Hematology Oncology

    West Hills, California 92056
    United States

    Site Not Available

  • Cancer Center of Central Connecticut

    Southington, Connecticut 06489
    United States

    Site Not Available

  • Florida Cancer Specialists North Region Sarah Cannon Research

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • Illinois Cancer Care, P.C.

    Peoria, Illinois 61615
    United States

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  • LRG Healthcare Oncology Clinic

    Laconia, Indiana 03246
    United States

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  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana 46628
    United States

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  • Iowa Oncology Research Association

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • University of Louisville, J.G. Brown Cancer Center

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Providence Cancer Institute

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Coborn Cancer Center at the St. Cloud Hospital

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • Coborn Cancer Center

    St. Cloud, Minnesota 56303
    United States

    Site Not Available

  • New Hampshire Oncology-Hematology P.A

    Concord, New Hampshire 03301
    United States

    Site Not Available

  • NH Oncology - Hematology, PA

    Hooksett, New Hampshire 03106
    United States

    Site Not Available

  • The Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Hematology-Oncology Associates of Northern NJ

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • University of New Mexico

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10065
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Wake Forest University Health Services

    Winston Salem, North Carolina 27157
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Oncology Hematology Care Sarah Cannon Research

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Local Institution - 028

    Portland, Oregon 97213
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • St Francis Hospital

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Sarah Cannon Research Inst

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Arlington Cancer Center

    Arlington, Texas 76012
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Northwest Medical Specialties PLLC

    Tacoma, Washington 98405
    United States

    Site Not Available

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