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Trial record 8 of 498 for:    LENALIDOMIDE AND every 28 days

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01938001
Recruitment Status : Active, not recruiting
First Posted : September 10, 2013
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief 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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: Rituximab Drug: Lenalidomide Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2013
Actual Primary Completion Date : June 22, 2018
Estimated Study Completion Date : December 28, 2021


Arm Intervention/treatment
Experimental: Rituximab and Lenalidomide
Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days, up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
Drug: Rituximab
Rituximab 375mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) on Day 1 of every 28 day cycle from Cycles 2 to 5
Other Name: Rituxan

Drug: Lenalidomide
Lenalidomide 20mg by mouth (PO) daily on Days 1 to 21 every 28 days up to 12 cycles
Other Name: CC-5013, Revlimid

Active Comparator: Rituximab and Placebo
Participants received riituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up, to 12 cycles.
Drug: Rituximab
Rituximab 375mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) on Day 1 of every 28 day cycle from Cycles 2 to 5
Other Name: Rituxan

Drug: Placebo
Placebo (identical matched capsule) PO daily on Days 1 to 21 every 28 days




Primary Outcome Measures :
  1. Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC) [ Time Frame: From randomization of study drug up to disease progression or death, which occurred first; up to the data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months). ]
    Progression-free survival (PFS) was defined as the time from date of randomization into the study to the first observation of documented disease progression or death due to any cause, whichever occurred first. PFS was based on the data from the IRC review using the modified 2007 International Working Group Response Criteria (IWGRC) using FDA censoring rules.


Secondary Outcome Measures :
  1. Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC [ Time Frame: From first dose of investigational product (IP) to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomiade arm and 11.04 months in the rituximab/placebo arm ]
    DCCR was defined as the percentage of participants with a best response of complete response (CR) that lasted no less than one year (≥ 48 weeks) during the study prior to administration of new anti-lymphoma therapy. A CR is defined as a complete disappearance of any disease-related symptoms and normalization of biochemical abnormalities.

  2. Kaplan-Meier Estimate of Overall Survival (OS) [ Time Frame: From the date of randomization to the cut-off date of 22 June 2018; The overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months) ]
    Overall survival was defined as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.

  3. Percentage of Participants With an Objective Response as Assessed by the IRC According to the 2007 IWGRC [ Time Frame: From date of first dose to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm ]
    Percentage of participants with an objective response is defined as having a response of at least a PR during the study without administration of new anti-lymphoma therapy. A complete response = a complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities; a partial response (PR) = 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD.

  4. Percentage of Participants With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC [ Time Frame: From date of first dose up to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm ]
    Percentage of participants with a best response of at CR during the study without administration of new anti-lymphoma therapy. A CR = Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.

  5. Kaplan-Meier Estimate of Duration of Objective Response as Assessed by the IRC According to the 2007 IWGRC [ Time Frame: From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months). ]
    Duration of response (DOR) was defined as the time from initial response (at least PR) until documented progressive disease (PD) or death. Participants who had not progressed at the time of analysis were censored at the last assessment date that the participant was known to be progression free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participants was known to be progression free.

  6. Kaplan-Meier Estimate of Duration of Complete Response (DOCR) as Assessed by the IRC According to the 2007 IWGRC [ Time Frame: From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months). ]
    DOCR was defined as the time from initial CR until documented PD or death. Participants who had not progressed at the time of analysis were censored at the last assessment date that the participant was known to be progression free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participants was known to be progression free.

  7. Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC [ Time Frame: From date of randomization to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months). ]
    Event-free survival (EFS) was defined as the time from date of randomization to date of first documented progression, relapse, institution of new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy) or death from any cause. Responding participants and those who were lost to follow up were censored at their last tumor assessment date.

  8. Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT) [ Time Frame: From randomization to data cut off of 22 Jun 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months). ]
    Time to next anti-lymphoma treatment (TTNLT) was defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy or immunotherapy). The time to the next anti-lymphoma treatment was of special interest to the study.

  9. Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From the first dose of study drug up to 28 days after the last dose of IP and those SAEs made known at any time; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm ]

    TEAEs include AEs that started or worsened between the date of the first dose and 28 days after the date of the last dose. A serious adverse event (SAE) is any:

    • Death;
    • Life-threatening event;
    • Any inpatient hospitalization or prolongation of existing hospitalization;
    • Persistent or significant disability or incapacity;
    • Congenital anomaly or birth defect;
    • Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.03) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938001


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Locations
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United States, Alabama
Mitchell Cancer Center, University of South Alabama
Mobile, Alabama, United States, 36604
United States, Arizona
Arizona Center for Cancer Care
Glendale, Arizona, United States, 85306
United States, California
Southwest Cancer Care Medical Group
Escondido, California, United States, 92025
Marin Oncology Associates
Greenbrae, California, United States, 94904-2007
Wilshire Oncology Medical Group, Inc
La Verne, California, United States, 91750
North County Hematology Oncology (NCHO) - TRM, LLC.
Oceanside, California, United States, 92056
Hematology-Oncology Medical Group of Orange County, Inc.
Orange, California, United States, 92868
UC Davis Medical Center
Sacramento, California, United States, 95817
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
Wellness Hematology Oncology
West Hills, California, United States, 92056
United States, Connecticut
Cancer Center of Central Connecticut
Southington, Connecticut, United States, 06489
United States, Florida
Florida Cancer Specialists North Region Sarah Cannon Research
Saint Petersburg, Florida, United States, 33705
United States, Illinois
Illinois Cancer Care, P.C.
Peoria, Illinois, United States, 61615
United States, Indiana
LRG Healthcare Oncology Clinic
Laconia, Indiana, United States, 03246
United States, Iowa
Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
United States, Kentucky
University of Louisville, J.G. Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Michigan
Providence Cancer Institute
Southfield, Michigan, United States, 48075
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Coborn Cancer Center at the St. Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
United States, New Hampshire
NH Oncology - Hematology, PA
Hooksett, New Hampshire, United States, 03106
United States, New Jersey
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Hematology-Oncology Associates of Northern NJ
Morristown, New Jersey, United States, 07962
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87102
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Oncology Hematology Care Sarah Cannon Research
Cincinnati, Ohio, United States, 45242
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, South Carolina
St Francis Hospital
Greenville, South Carolina, United States, 29607
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Sarah Cannon Research Inst
Nashville, Tennessee, United States, 37203
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Northwest Medical Specialties PLLC
Tacoma, Washington, United States, 98405
Belgium
AZ St-Jan Brugge Oostende AV
Brugge, Belgium, 8000
UZ Gent
Gent, Belgium, 9000
AZ Groeninge
Kortrijk, Belgium, 8500
CHU Mont -Godinne
Yvoir, Belgium, 5530
Brazil
Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Associacao Educudora Sao Carlos AESC Hospital Giovanni Battista HGB Hospital Mae de Deus Center
Porto Alegre, Rio Grande Do Sul, Brazil, 90740-340
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil, 14784-400
Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú
Jau/SP, São Paulo, Brazil, 17210-080
MS INCA HC I Hospital do Cancer I
Rio De Janeiro, Brazil, 20231-130
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, Brazil, 01308 050
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, Brazil, 01321-001
Fundação Antonio Prudente - AC Camargo Câncer center
São Paulo, Brazil, 01509-900
China
Beijing Cancer Hospital
Beijing, PR, China, 100142
Peking University People's Hospital
Beijing, China, 100044
307 Hospital of PLA
Beijing, China, 100071
Peking Union Medical College Hospital
Beijing, China, 100730
The Third Xiangya hospital of central south university
Changsha, China, 410013
West China Hospital of Sichuan University
Chengdu, China, 610041
Fujian Medical University Union Hospital
Fuzhou, China, 350001
Sun Yat-sen University Cancer Center
Guangzhou, China, 510060
Guangdong General Hospital
Guangzhou, China, 510080
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou City, China, 310003
Jiangsu Province Hospital The First Hospital affiliated with Nanjing Medical University
Nanjing, China, 210029
Cancer Hospital, Fudan University
Shanghai, China, 200032
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
The First Affiliated Hospital of Soochow University
Suzhou, China, 215006
Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, China, 300020
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China, 300060
Xijing Hospital
Xi'an, China, 710032
Czechia
Interni hematoonkologicka klinika
Brno, Czechia, 625 00
Fakultni nemocnice Hradec Kralove, IV.interni hematologicka klinika
Hradec Kralove, Czechia, 500 05
Fakultni Nemocnice Ostrava, Klinika hematoonkologie,
Ostrava, Czechia, 70852
Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika
Prague 10, Czechia, 100 34
Vseobecna Fakultni Nemocnice v Praze
Praha, Czechia, 128 08
France
CHU d'Angers
Angers, France, 49033
Centre Hospitalier Universitaire d'Avicennes
Bobigny Cedex, France, 93009
CHRU de Brest - Hopital Morvan
Brest Cedex, France, 29609
Hopital Saint-Louis
Paris, France, 75010
CH Perpignan - Hopital Saint-Jean
Perpignan, France, 66046
CHU de Poitiers
Poitiers, France, 86021
Centre Hospitalier de Valence
Valence, France, 26953
Germany
Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin
Berlin, Germany, 12203
Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum
Berlin, Germany, 13353
Krankenhaus Nordwest
Frankfurt, Germany, 60488
Onkologische Schwerpunktpraxis Leer - Emden
Leer, Germany, 26789
Kliniken Maria Hilf GmbH
Mönchengladbach, Germany, 41063
Klinkum der Stadt Villingen-Schwenningen GmbH
Villingen-Schwenningen, Germany, 78052
Israel
Soroka University Medical Center
Beer Sheva, Israel, 84101
Hadassah University Hospital
Jerusalem, Israel, 91120
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239
Italy
Centro di Riferimento Oncologico - IRCCS
Aviano (PN), Italy, 33081
U.O.C. Ematologia
Barletta, Italy, 76121
A.O.U. di Bologna Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Nesima
Catania, Italy, 95124
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
Meldola, Italy, 47014
Istituto Europeo di Oncologia - IEO
Milano, Italy, 20141
Ospedale Niguarda Ca Granda
Milano, Italy, 20162
IRCCS- Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione "G. Pascale"
Napoli, Italy, 80131
Az. Osp. Vincenzo Cervello
Palermo, Italy, 90146
Casa di Cura La Maddalena
Palermo, Italy, 90146
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy, 43100
Ospedale di Ravenna
Ravenna, Italy, 48121
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria, Italy, 89100
Ospedale degli Infermi di Rimini
Rimini, Italy, 47900
Azienda Ospedaliera S. Andrea - Università La Sapienza
Roma, Italy, 00189
Japan
National Cancer Center Hospital
Chuo-ku, Japan, 104-0045
Chugoku Central Hospital
Hiroshima, Japan, 7200001
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Kobe City Medical Center General Hospital
Kobe-city, Japan, 650-0047
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Koto-ku, Japan, 135-8550
University Hospital, Kyoto Prefectural University of Medicine
Kyoto-city, Japan, 602-8566
Toranomon Hospital
Minato-ku, Japan, 105-8470
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, Japan, 852-8511
Nagoya Medical Center,Division of Hematology/Oncology
Nagoya, Japan, 460-0001
National University Corporation Tohoku University, Tohoku University Hospital
Sendai-shi, Japan, 980-8574
Poland
Malopolskie Centrum Medyczne S.C.
Kraków, Poland, 30-510
Instytut Hematologii i Transfuzjologii w Warszawie
Warszawa, Poland, 02-776
Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie
Warszawa, Poland, 02-781
Portugal
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil
Lisboa, Portugal, 1099-023
Instituto Portugues de Oncologia do Porto, Francisco Gentil
Porto, Portugal, 4200-072
Puerto Rico
Hospital Auxilio Muto Centro de Cancer
San Juan, Puerto Rico, 00918
Russian Federation
Krasnoyarsk Regional Clinical Hospital
Krasnoyarsk, Russian Federation, 660022
Russian Academy of Medical Sciences Institution
Moscow, Russian Federation, 115478
Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin
Moscow, Russian Federation, 125101
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
St Petersburg, Russian Federation, 197341
St. Petersburg Pavlov State Medical University
St.Petersburg, Russian Federation, 197022
The Ministry of Health and Social Development of the Tula region state institution Health Tula regio
Tula, Russian Federation, 300053
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Hospital Costa del Sol
Marbella, Spain, 29603
Hospital Morales Meseguer
Murcia, Spain, 30008
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universitario Virgen Del Rocio
Sevilla, Spain, 41013
Turkey
Cukurova University Medical Faculty Balcali Hospital
Adana, Turkey, 01330
Hacettepe Universitesi
Ankara, Turkey, 06100
Pamukkale University Medical Faculty
Denizli, Turkey, 20070
Gaziantep University
Gaziantep, Turkey, 27310
Marmara University
Istanbul, Turkey, 34840
Dokuz Eylul University Izmir
Izmir, Turkey, 35340
19 Mayis Medical Faculty - Samsun
Samsun, Turkey, 55139
Kocaeli Derince Training and Research Hospital
Umuttepe Kocaeli, Turkey, 41380
United Kingdom
Eastbourne District General Hospital
Eastbourne, United Kingdom, BN21 2UD
Royal Liverpool University Hospital, Prescot Street
Liverpool, United Kingdom, L7 8XP
Barts Cancer Institute, Queen Mary University of London, Charterhouse Square
London, United Kingdom, EC1M 6BQ
Southend University Hospital NHS Foundation Trust, Prittlewell Chase
Westcliff on Sea, United Kingdom, SS0 0RY
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Stacey Kalambakas, MD Celgene
  Study Documents (Full-Text)

Documents provided by Celgene:
Statistical Analysis Plan  [PDF] June 21, 2018
Study Protocol  [PDF] December 13, 2018


Publications of Results:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01938001     History of Changes
Other Study ID Numbers: CC-5013-NHL-007
First Posted: September 10, 2013    Key Record Dates
Results First Posted: August 13, 2019
Last Update Posted: August 13, 2019
Last Verified: July 2019
Keywords provided by Celgene:
Non-Hodgkins Follicular lymphoma, Non-Hodgkins Marginal zone lymphoma, treatment for follicular lymphoma, treatment for Marginal zone lymphoma
Additional relevant MeSH terms:
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Lenalidomide
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors