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

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rituximab
Lenalidomide
Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Non-Hodgkins Follicular lymphoma, Non-Hodgkins Marginal zone lymphoma, treatment for follicular lymphoma, treatment for Marginal zone lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mitchell Cancer Center, University of South Alabama
  • Arizona Center for Cancer Care
  • Southwest Cancer Care Medical Group
  • Marin Oncology Associates
  • Wilshire Oncology Medical Group, Inc
  • North County Hematology Oncology (NCHO) - TRM, LLC.
  • Hematology-Oncology Medical Group of Orange County, Inc.
  • UC Davis Medical Center
  • Central Coast Medical Oncology Corporation
  • Wellness Hematology Oncology
  • Cancer Center of Central Connecticut
  • Florida Cancer Specialists North Region Sarah Cannon Research
  • Illinois Cancer Care, P.C.
  • LRG Healthcare Oncology Clinic
  • Iowa Oncology Research Association
  • University of Louisville, J.G. Brown Cancer Center
  • Providence Cancer Institute
  • Mayo Clinic
  • Coborn Cancer Center at the St. Cloud Hospital
  • NH Oncology - Hematology, PA
  • The Cancer Center at Hackensack University Medical Center
  • Hematology-Oncology Associates of Northern NJ
  • University of New Mexico
  • Weill Cornell Medical College
  • SUNY Upstate Medical University
  • Wake Forest Baptist Health
  • Oncology Hematology Care Sarah Cannon Research
  • Local Institution - 028
  • Providence Portland Medical Center
  • St Francis Hospital
  • Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
  • Sarah Cannon Research Inst
  • Arlington Cancer Center
  • MD Anderson Cancer Center
  • Northwest Medical Specialties PLLC
  • AZ St-Jan Brugge Oostende AV
  • Local Institution - 371
  • UZ Gent
  • AZ Groeninge
  • CHU Mont -Godinne
  • Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento
  • Hospital de Clínicas de Porto Alegre
  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
  • Associacao Educudora Sao Carlos AESC Hospital Giovanni Battista HGB Hospital Mae de Deus Center
  • Fundacao Pio XII - Hospital de Cancer de Barretos
  • Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú
  • MS INCA HC I Hospital do Cancer I
  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
  • Real e Benemerita Associacao Portuguesa de Beneficencia
  • Fundação Antonio Prudente - AC Camargo Câncer center
  • Beijing Cancer Hospital
  • Peking University People's Hospital
  • 307 Hospital of PLA
  • Peking Union Medical College Hospital
  • The Third Xiangya hospital of central south university
  • West China Hospital of Sichuan University
  • Fujian Medical University Union Hospital
  • Sun Yat-sen University Cancer Center
  • Guangdong General Hospital
  • Local Institution - 600
  • The First Affiliated Hospital of Medical School of Zhejiang University
  • Local Institution - 604
  • Jiangsu Province Hospital The First Hospital affiliated with Nanjing Medical University
  • Cancer Hospital, Fudan University
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • The First Affiliated Hospital of Soochow University
  • Chinese Academy of Medical Sciences & Peking Union Medical College
  • Tianjin Medical University Cancer Institute and Hospital
  • Xijing Hospital
  • Interni hematoonkologicka klinika
  • Fakultni nemocnice Hradec Kralove, IV.interni hematologicka klinika
  • Fakultni Nemocnice Ostrava, Klinika hematoonkologie,
  • Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika
  • Local Institution - 534
  • Vseobecna Fakultni Nemocnice v Praze
  • CHU d'Angers
  • Centre Hospitalier Universitaire d'Avicennes
  • CHRU de Brest - Hopital Morvan
  • Hopital Saint-Louis
  • CH Perpignan - Hopital Saint-Jean
  • CHU de Poitiers
  • Centre Hospitalier de Valence
  • Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin
  • Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum
  • Krankenhaus Nordwest
  • Onkologische Schwerpunktpraxis Leer - Emden
  • Kliniken Maria Hilf GmbH
  • Klinkum der Stadt Villingen-Schwenningen GmbH
  • Soroka University Medical Center
  • Hadassah University Hospital
  • Tel-Aviv Sourasky Medical Center
  • Centro di Riferimento Oncologico - IRCCS
  • U.O.C. Ematologia
  • A.O.U. di Bologna Policlinico S.Orsola-Malpighi
  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Nesima
  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
  • Istituto Europeo di Oncologia - IEO
  • Ospedale Niguarda Ca Granda
  • IRCCS- Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione "G. Pascale"
  • Az. Osp. Vincenzo Cervello
  • Casa di Cura La Maddalena
  • Azienda Ospedaliero-Universitaria di Parma
  • Ospedale di Ravenna
  • Azienda Ospedaliera Bianchi-Melacrino-Morelli
  • Ospedale degli Infermi di Rimini
  • Azienda Ospedaliera S. Andrea - Università La Sapienza
  • Local Institution - 340
  • Local Institution - 708
  • Local Institution - 709
  • National Cancer Center Hospital
  • Chugoku Central Hospital
  • National Cancer Center Hospital East
  • Kobe City Medical Center General Hospital
  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research
  • Local Institution - 700
  • University Hospital, Kyoto Prefectural University of Medicine
  • Toranomon Hospital
  • The Japanese Red Cross Nagasaki Genbaku Hospital
  • Nagoya Medical Center,Division of Hematology/Oncology
  • National University Corporation Tohoku University, Tohoku University Hospital
  • Malopolskie Centrum Medyczne S.C.
  • Instytut Hematologii i Transfuzjologii w Warszawie
  • Local Institution - 514
  • Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie
  • Local Institution - 513
  • Instituto Portugues de Oncologia de Lisboa, Francisco Gentil
  • Local Institution - 330
  • Instituto Portugues de Oncologia do Porto, Francisco Gentil
  • Local Institution - 331
  • Hospital Auxilio Muto Centro de Cancer
  • Krasnoyarsk Regional Clinical Hospital
  • Russian Academy of Medical Sciences Institution
  • Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin
  • Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
  • St. Petersburg Pavlov State Medical University
  • The Ministry of Health and Social Development of the Tula region state institution Health Tula regio
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario Reina Sofia
  • Local Institution - 314
  • Hospital Universitario Infanta Leonor
  • Hospital Universitario Fundacion Jimenez Diaz
  • Hospital Costa del Sol
  • Local Institution - 315
  • Hospital Morales Meseguer
  • Local Institution - 318
  • Hospital Universitario de Salamanca
  • Local Institution - 311
  • Hospital Universitario Virgen Del Rocio
  • Cukurova University Medical Faculty Balcali Hospital
  • Hacettepe Universitesi
  • Pamukkale University Medical Faculty
  • Gaziantep University
  • Marmara University
  • Dokuz Eylul University Izmir
  • 19 Mayis Medical Faculty - Samsun
  • Kocaeli Derince Training and Research Hospital
  • Eastbourne District General Hospital
  • Royal Liverpool University Hospital, Prescot Street
  • Barts Cancer Institute, Queen Mary University of London, Charterhouse Square
  • Southend University Hospital NHS Foundation Trust, Prittlewell Chase

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rituximab and Lenalidomide

Rituximab and Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC)
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

Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC
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.
Kaplan-Meier Estimate of Overall Survival (OS)
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.
Percentage of Participants With an Objective Response as Assessed by the IRC According to the 2007 IWGRC
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.
Percentage of Participants With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC
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.
Kaplan-Meier Estimate of Duration of Objective Response as Assessed by the IRC According to the 2007 IWGRC
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.
Kaplan-Meier Estimate of Duration of Complete Response (DOCR) as Assessed by the IRC According to the 2007 IWGRC
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.
Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC
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.
Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT)
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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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

Full Information

First Posted
September 5, 2013
Last Updated
January 26, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT01938001
Brief Title
Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
Acronym
AUGMENT
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 Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 21, 2013 (Actual)
Primary Completion Date
June 22, 2018 (Actual)
Study Completion Date
January 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
Non-Hodgkins Follicular lymphoma, Non-Hodgkins Marginal zone lymphoma, treatment for follicular lymphoma, treatment for Marginal zone lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
358 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab and Lenalidomide
Arm Type
Experimental
Arm Description
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.
Arm Title
Rituximab and Placebo
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
CC-5013, Revlimid
Intervention Description
Lenalidomide 20mg by mouth (PO) daily on Days 1 to 21 every 28 days up to 12 cycles
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (identical matched capsule) PO daily on Days 1 to 21 every 28 days
Primary Outcome Measure Information:
Title
Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC)
Description
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.
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).
Secondary Outcome Measure Information:
Title
Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC
Description
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.
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
Title
Kaplan-Meier Estimate of Overall Survival (OS)
Description
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.
Time Frame
From date of randomization to death due to any cause (Average of 55.71 months and a maximum up to 95.2 months)
Title
Percentage of Participants With an Objective Response as Assessed by the IRC According to the 2007 IWGRC
Description
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.
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
Title
Percentage of Participants With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC
Description
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.
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
Title
Kaplan-Meier Estimate of Duration of Objective Response as Assessed by the IRC According to the 2007 IWGRC
Description
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.
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).
Title
Kaplan-Meier Estimate of Duration of Complete Response (DOCR) as Assessed by the IRC According to the 2007 IWGRC
Description
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.
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).
Title
Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC
Description
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.
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).
Title
Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT)
Description
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.
Time Frame
From date of randomization to date of first documented administration of a new anti-lymphoma treatment (Average of 55.71 months and a maximum up to 95.2 months)
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
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
Time Frame
From first dose to 28 days post last dose (Average of 55.71 months and a maximum up to 95.2 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Mitchell Cancer Center, University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Arizona Center for Cancer Care
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Southwest Cancer Care Medical Group
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Marin Oncology Associates
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904-2007
Country
United States
Facility Name
Wilshire Oncology Medical Group, Inc
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
North County Hematology Oncology (NCHO) - TRM, LLC.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Hematology-Oncology Medical Group of Orange County, Inc.
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Central Coast Medical Oncology Corporation
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Wellness Hematology Oncology
City
West Hills
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Cancer Center of Central Connecticut
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
Facility Name
Florida Cancer Specialists North Region Sarah Cannon Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Illinois Cancer Care, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
LRG Healthcare Oncology Clinic
City
Laconia
State/Province
Indiana
ZIP/Postal Code
03246
Country
United States
Facility Name
Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
University of Louisville, J.G. Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Providence Cancer Institute
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Coborn Cancer Center at the St. Cloud Hospital
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
NH Oncology - Hematology, PA
City
Hooksett
State/Province
New Hampshire
ZIP/Postal Code
03106
Country
United States
Facility Name
The Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Hematology-Oncology Associates of Northern NJ
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Oncology Hematology Care Sarah Cannon Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Local Institution - 028
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
St Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Sarah Cannon Research Inst
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Northwest Medical Specialties PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
AZ St-Jan Brugge Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Local Institution - 371
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHU Mont -Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Associacao Educudora Sao Carlos AESC Hospital Giovanni Battista HGB Hospital Mae de Deus Center
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90740-340
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú
City
Jau/SP
State/Province
São Paulo
ZIP/Postal Code
17210-080
Country
Brazil
Facility Name
MS INCA HC I Hospital do Cancer I
City
Rio De Janeiro
ZIP/Postal Code
20231-130
Country
Brazil
Facility Name
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
City
São Paulo
ZIP/Postal Code
01308 050
Country
Brazil
Facility Name
Real e Benemerita Associacao Portuguesa de Beneficencia
City
São Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Fundação Antonio Prudente - AC Camargo Câncer center
City
São Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Beijing Cancer Hospital
City
Beijing, PR
ZIP/Postal Code
100142
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
307 Hospital of PLA
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The Third Xiangya hospital of central south university
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Local Institution - 600
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiliated Hospital of Medical School of Zhejiang University
City
Hangzhou City
ZIP/Postal Code
310003
Country
China
Facility Name
Local Institution - 604
City
Hangzhou City
ZIP/Postal Code
310006
Country
China
Facility Name
Jiangsu Province Hospital The First Hospital affiliated with Nanjing Medical University
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Cancer Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215006
Country
China
Facility Name
Chinese Academy of Medical Sciences & Peking Union Medical College
City
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Xijing Hospital
City
Xi'an
ZIP/Postal Code
710032
Country
China
Facility Name
Interni hematoonkologicka klinika
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove, IV.interni hematologicka klinika
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni Nemocnice Ostrava, Klinika hematoonkologie,
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika
City
Prague 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Local Institution - 534
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Vseobecna Fakultni Nemocnice v Praze
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Centre Hospitalier Universitaire d'Avicennes
City
Bobigny Cedex
ZIP/Postal Code
93009
Country
France
Facility Name
CHRU de Brest - Hopital Morvan
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CH Perpignan - Hopital Saint-Jean
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Hospitalier de Valence
City
Valence
ZIP/Postal Code
26953
Country
France
Facility Name
Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Krankenhaus Nordwest
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Leer - Emden
City
Leer
ZIP/Postal Code
26789
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
Klinkum der Stadt Villingen-Schwenningen GmbH
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Centro di Riferimento Oncologico - IRCCS
City
Aviano (PN)
ZIP/Postal Code
33081
Country
Italy
Facility Name
U.O.C. Ematologia
City
Barletta
ZIP/Postal Code
76121
Country
Italy
Facility Name
A.O.U. di Bologna Policlinico S.Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Nesima
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Europeo di Oncologia - IEO
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Ospedale Niguarda Ca Granda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
IRCCS- Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione "G. Pascale"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Az. Osp. Vincenzo Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Casa di Cura La Maddalena
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Ospedale di Ravenna
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Azienda Ospedaliera Bianchi-Melacrino-Morelli
City
Reggio Calabria
ZIP/Postal Code
89100
Country
Italy
Facility Name
Ospedale degli Infermi di Rimini
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Azienda Ospedaliera S. Andrea - Università La Sapienza
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Local Institution - 340
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Local Institution - 708
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8511
Country
Japan
Facility Name
Local Institution - 709
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Chugoku Central Hospital
City
Hiroshima
ZIP/Postal Code
7200001
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe-city
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Local Institution - 700
City
Koto-ku
ZIP/Postal Code
1350063
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine
City
Kyoto-city
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-ku
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
The Japanese Red Cross Nagasaki Genbaku Hospital
City
Nagasaki
ZIP/Postal Code
852-8511
Country
Japan
Facility Name
Nagoya Medical Center,Division of Hematology/Oncology
City
Nagoya
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
National University Corporation Tohoku University, Tohoku University Hospital
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Malopolskie Centrum Medyczne S.C.
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii w Warszawie
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Local Institution - 514
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 513
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Local Institution - 330
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Instituto Portugues de Oncologia do Porto, Francisco Gentil
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Local Institution - 331
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Hospital Auxilio Muto Centro de Cancer
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Krasnoyarsk Regional Clinical Hospital
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Russian Academy of Medical Sciences Institution
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
Facility Name
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
City
St Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
St. Petersburg Pavlov State Medical University
City
St.Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
The Ministry of Health and Social Development of the Tula region state institution Health Tula regio
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Local Institution - 314
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Costa del Sol
City
Marbella
ZIP/Postal Code
29603
Country
Spain
Facility Name
Local Institution - 315
City
Marbella
ZIP/Postal Code
29603
Country
Spain
Facility Name
Hospital Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Local Institution - 318
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Local Institution - 311
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Cukurova University Medical Faculty Balcali Hospital
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Hacettepe Universitesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Pamukkale University Medical Faculty
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Facility Name
Gaziantep University
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34840
Country
Turkey
Facility Name
Dokuz Eylul University Izmir
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
19 Mayis Medical Faculty - Samsun
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Kocaeli Derince Training and Research Hospital
City
Umuttepe Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Eastbourne District General Hospital
City
Eastbourne
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital, Prescot Street
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Barts Cancer Institute, Queen Mary University of London, Charterhouse Square
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust, Prittlewell Chase
City
Westcliff on Sea
ZIP/Postal Code
SS0 0RY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30184451
Citation
Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Daguindau N, Le Gouill S, Pica GM, Martin Garcia-Sancho A, Lopez-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, Andre M, Zachee P, Sehn LH, Tobinai K, Cartron G, Liu D, Wang J, Xerri L, Salles GA; RELEVANCE Trial Investigators. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018 Sep 6;379(10):934-947. doi: 10.1056/NEJMoa1805104.
Results Reference
background
PubMed Identifier
30897038
Citation
Leonard JP, Trneny M, Izutsu K, Fowler NH, Hong X, Zhu J, Zhang H, Offner F, Scheliga A, Nowakowski GS, Pinto A, Re F, Fogliatto LM, Scheinberg P, Flinn IW, Moreira C, Cabecadas J, Liu D, Kalambakas S, Fustier P, Wu C, Gribben JG; AUGMENT Trial Investigators. AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2019 May 10;37(14):1188-1199. doi: 10.1200/JCO.19.00010. Epub 2019 Mar 21.
Results Reference
result
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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