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

January 26, 2023 updated by: Celgene

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

358

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma.
  • Subjects taking corticosteroids during the last week prior to study treatment, unless administered at a dose equivalent to < 20 mg/day prednisone or prednisolone.
  • Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 6 months.
  • Known seropositive for or active viral infection with hepatitis B virus (HBV) or/and human immunodeficiency virus (HIV).
  • Known hepatitis C virus (HCV) positive with chronic HCV or active viral infection with HCV hepatitis requiring anti-viral medication (at time of randomization).
  • Life expectancy < 6 months.
  • Known sensitivity or allergy to murine products.
  • Prior history of malignancies, other than follicular or marginal zone lymphoma, unless the subject has been free of the disease for ≥ 5 years.
  • Prior use of lenalidomide.
  • Known allergy to thalidomide.
  • Neuropathy > Grade 1.
  • Presence or history of central nervous system involvement by lymphoma.
  • Subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it.
  • Uncontrolled intercurrent illness.
  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document.
  • Pregnant or lactating females.
  • Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Rituxan
Drug: Lenalidomide
Lenalidomide 20mg by mouth (PO) daily on Days 1 to 21 every 28 days up to 12 cycles
Other Names:
  • 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 Names:
  • Rituxan
Drug: Placebo
Placebo (identical matched capsule) PO daily on Days 1 to 21 every 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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 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.
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
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.
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).
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.
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).
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.
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).
Kaplan-Meier Estimate of Overall Survival (OS)
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)
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.
From date of randomization to death due to any cause (Average of 55.71 months and a maximum up to 95.2 months)
Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT)
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)
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.
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)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: From first dose to 28 days post last dose (Average of 55.71 months and a maximum up to 95.2 months)
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
From first dose to 28 days post last dose (Average of 55.71 months and a maximum up to 95.2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2013

Primary Completion (Actual)

June 22, 2018

Study Completion (Actual)

January 26, 2022

Study Registration Dates

First Submitted

September 5, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-NHL-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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