AzTrials
AzTrials

Lymphoma, Non-HodgkinPhase 3AUGMENTNCT01938001

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

A Phase 3 study testing Rituximab and Lenalidomide in people with Lymphoma, Non-Hodgkin, run by Celgene at 160 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin
What is being tested?
Rituximab and Lenalidomide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
358 participants
Where
160 sitesin 17 countries
Study dates
21 Nov 2013to 26 Jan 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

160 sites in 17 countries.

160 sites in 17 countries

United States35 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87102

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Oncology Hematology Care Sarah Cannon Research

    Cincinnati, Ohio, 45242

  • Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • Southwest Cancer Care Medical Group

    Escondido, California, 92025

  • Arizona Center for Cancer Care

    Glendale, Arizona, 85306

  • Marin Oncology Associates

    Greenbrae, California, 94904-2007

  • St Francis Hospital

    Greenville, South Carolina, 29607

  • The Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • NH Oncology - Hematology, PA

    Hooksett, New Hampshire, 03106

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Wilshire Oncology Medical Group, Inc

    La Verne, California, 91750

  • LRG Healthcare Oncology Clinic

    Laconia, Indiana, 03246

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

    Louisville, Kentucky, 40202

  • Mitchell Cancer Center, University of South Alabama

    Mobile, Alabama, 36604

  • Hematology-Oncology Associates of Northern NJ

    Morristown, New Jersey, 07962

  • Sarah Cannon Research Inst

    Nashville, Tennessee, 37203

  • Weill Cornell Medical College

    New York, New York, 10065

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

    Oceanside, California, 92056

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

    Orange, California, 92868

  • Illinois Cancer Care, P.C.

    Peoria, Illinois, 61615

  • Local Institution - 028

    Portland, Oregon, 97213

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Coborn Cancer Center at the St. Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • Providence Cancer Institute

    Southfield, Michigan, 48075

  • Cancer Center of Central Connecticut

    Southington, Connecticut, 06489

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

    Spartanburg, South Carolina, 29303

  • Florida Cancer Specialists North Region Sarah Cannon Research

    St. Petersburg, Florida, 33705

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405

  • Wellness Hematology Oncology

    West Hills, California, 92056

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

China19 sites

  • Peking University People's Hospital

    Beijing, 100044

  • 307 Hospital of PLA

    Beijing, 100071

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Beijing Cancer Hospital

    Beijing, PR, 100142

  • The Third Xiangya hospital of central south university

    Changsha, 410013

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • Sun Yat-sen University Cancer Center

    Guangzhou, 510060

  • Guangdong General Hospital

    Guangzhou, 510080

  • Local Institution - 600

    Guangzhou, 510080

  • The First Affiliated Hospital of Medical School of Zhejiang University

    Hangzhou, 310003

  • Local Institution - 604

    Hangzhou, 310006

  • Jiangsu Province Hospital The First Hospital affiliated with Nanjing Medical University

    Nanjing, 210029

  • Cancer Hospital, Fudan University

    Shanghai, 200032

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

    Shanghai

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • Chinese Academy of Medical Sciences & Peking Union Medical College

    Tianjin, 300020

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

  • Xijing Hospital

    Xi'an, 710032

Other trials in China

Italy16 sites

  • Centro di Riferimento Oncologico - IRCCS

    Aviano (PN), 33081

  • U.O.C. Ematologia

    Barletta, 76121

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

    Bologna, 40138

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

    Catania, 95124

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

    Meldola, 47014

  • Istituto Europeo di Oncologia - IEO

    Milan, 20141

  • Ospedale Niguarda Ca Granda

    Milan, 20162

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

    Naples, 80131

  • Az. Osp. Vincenzo Cervello

    Palermo, 90146

  • Casa di Cura La Maddalena

    Palermo, 90146

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43100

  • Ospedale di Ravenna

    Ravenna, 48121

  • Azienda Ospedaliera Bianchi-Melacrino-Morelli

    Reggio Calabria, 89100

  • Ospedale degli Infermi di Rimini

    Rimini, 47900

  • Azienda Ospedaliera S. Andrea - Università La Sapienza

    Roma, 00189

  • Local Institution - 340

    Roma, 00189

Other trials in Italy

Japan13 sites

  • National Cancer Center Hospital

    Chūōku, 104-0045

  • Chugoku Central Hospital

    Hiroshima, 7200001

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research

    Kōtoku, 135-8550

  • Local Institution - 700

    Kōtoku, 1350063

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Local Institution - 709

    Minato-ku, Tokyo, 105-8470

  • Toranomon Hospital

    Minatoku, 105-8470

  • Local Institution - 708

    Nagasaki, Nagasaki, 852-8511

  • The Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, 852-8511

  • Nagoya Medical Center,Division of Hematology/Oncology

    Nagoya, 460-0001

  • National University Corporation Tohoku University, Tohoku University Hospital

    Sendai, 980-8574

Other trials in Japan

Spain12 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Local Institution - 314

    Córdoba, 14004

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Costa del Sol

    Marbella, 29603

  • Local Institution - 315

    Marbella, 29603

  • Hospital Morales Meseguer

    Murcia, 30008

  • Local Institution - 318

    Murcia, 30008

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Local Institution - 311

    Salamanca, 37007

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

Other trials in Spain

Brazil10 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú

    Jau/SP, São Paulo, 17210-080

  • Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

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

    Porto Alegre, Rio Grande do Sul, 90610-000

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

    Porto Alegre, Rio Grande do Sul, 90740-340

  • MS INCA HC I Hospital do Cancer I

    Rio de Janeiro, 20231-130

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 050

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01321-001

  • Fundação Antonio Prudente - AC Camargo Câncer center

    São Paulo, 01509-900

Other trials in Brazil

Turkey (Türkiye)8 sites

  • Cukurova University Medical Faculty Balcali Hospital

    Adana, 01330

  • Hacettepe Universitesi

    Ankara, 06100

  • Pamukkale University Medical Faculty

    Denizli, 20070

  • Gaziantep University

    Gaziantep, 27310

  • Marmara University

    Istanbul, 34840

  • Dokuz Eylul University Izmir

    Izmir, 35340

  • 19 Mayis Medical Faculty - Samsun

    Samsun, 55139

  • Kocaeli Derince Training and Research Hospital

    Umuttepe Kocaeli, 41380

Other trials in Turkey (Türkiye)

France7 sites

  • CHU d'Angers

    Angers, 49033

  • Centre Hospitalier Universitaire d'Avicennes

    Bobigny, 93009

  • CHRU de Brest - Hopital Morvan

    Brest, 29609

  • Hopital Saint-Louis

    Paris, 75010

  • CH Perpignan - Hopital Saint-Jean

    Perpignan, 66046

  • CHU de Poitiers

    Poitiers, 86021

  • Centre Hospitalier de Valence

    Valence, 26953

Other trials in France

Czechia6 sites

  • Interni hematoonkologicka klinika

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove, IV.interni hematologicka klinika

    Hradec Králové, 500 05

  • Fakultni Nemocnice Ostrava, Klinika hematoonkologie,

    Ostrava, 70852

  • Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika

    Prague, 100 34

  • Local Institution - 534

    Prague, 128 08

  • Vseobecna Fakultni Nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Germany6 sites

  • Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin

    Berlin, 12203

  • Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum

    Berlin, 13353

  • Krankenhaus Nordwest

    Frankfurt, 60488

  • Onkologische Schwerpunktpraxis Leer - Emden

    Leer, 26789

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, 41063

  • Klinkum der Stadt Villingen-Schwenningen GmbH

    Villingen-Schwenningen, 78052

Other trials in Germany

Russia6 sites

  • Krasnoyarsk Regional Clinical Hospital

    Krasnoyarsk, 660022

  • Russian Academy of Medical Sciences Institution

    Moscow, 115478

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

    Moscow, 125101

  • St. Petersburg Pavlov State Medical University

    Saint Petersburg, 197022

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

    Saint Petersburg, 197341

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

    Tula, 300053

Other trials in Russia

Belgium5 sites

  • AZ St-Jan Brugge Oostende AV

    Bruges, 8000

  • Local Institution - 371

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • AZ Groeninge

    Kortrijk, 8500

  • CHU Mont -Godinne

    Yvoir, 5530

Other trials in Belgium

Poland5 sites

  • Malopolskie Centrum Medyczne S.C.

    Krakow, 30-510

  • Instytut Hematologii i Transfuzjologii w Warszawie

    Warsaw, 02-776

  • Local Institution - 514

    Warsaw, 02-776

  • Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

  • Local Institution - 513

    Warsaw, 02-781

Other trials in Poland

Portugal4 sites

  • Instituto Portugues de Oncologia de Lisboa, Francisco Gentil

    Lisbon, 1099-023

  • Local Institution - 330

    Lisbon, 1099-023

  • Instituto Portugues de Oncologia do Porto, Francisco Gentil

    Porto, 4200-072

  • Local Institution - 331

    Porto, 4200-072

Other trials in Portugal

United Kingdom4 sites

  • Eastbourne District General Hospital

    Eastbourne, BN21 2UD

  • Royal Liverpool University Hospital, Prescot Street

    Liverpool, L7 8XP

  • Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

    London, EC1M 6BQ

  • Southend University Hospital NHS Foundation Trust, Prittlewell Chase

    Westcliff-on-Sea, SS0 0RY

Other trials in United Kingdom

Israel3 sites

  • Soroka University Medical Center

    Beersheba, 84101

  • Hadassah University Hospital

    Jerusalem, 91120

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Puerto Rico1 site

  • Hospital Auxilio Muto Centro de Cancer

    San Juan, 00918

Other trials in Puerto Rico

About this study

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

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.

Read the 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.

Being tested
Rituximab, Lenalidomide, Placebo
Keywords
Non-Hodgkins Follicular lymphoma, Non-Hodgkins Marginal zone lymphoma, treatment for follicular lymphoma, treatment for Marginal zone lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called Rituxan

    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

  • LenalidomideDrug

    Also called CC-5013, Revlimid

    Lenalidomide 20mg by mouth (PO) daily on Days 1 to 21 every 28 days up to 12 cycles

  • PlaceboDrug

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

Study groups in NCT01938001
Study groupRoleWhat they receive
Rituximab and LenalidomideExperimentalParticipants 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.
Receives: Drug: Rituximab; Drug: Lenalidomide
Rituximab and PlaceboActive comparatorParticipants 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.
Receives: Drug: Rituximab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    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.

    Measured: 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 outcomes (9)

  1. 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.

    Measured: 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

  2. 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.

    Measured: From date of randomization to death due to any cause (Average of 55.71 months and a maximum up to 95.2 months)

  3. 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.

    Measured: 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

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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).

  6. 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.

    Measured: 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).

  7. 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.

    Measured: 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).

  8. 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.

    Measured: 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)

  9. 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

    Measured: From first dose to 28 days post last dose (Average of 55.71 months and a maximum up to 95.2 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2013 (estimated)
  2. Study start21 Nov 2013
  3. Primary completion22 Jun 2018
  4. Study completion26 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01938001
Sponsor's protocol ID
CC-5013-NHL-007
Acronym
AUGMENT
Status last verified
Jan 2023
First submitted
5 Sep 2013
Last updated
22 Feb 2023
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30184451

  • 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.

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  • Leonard JP, Trneny M, Zhang H, Nowakowski GS, Izutsu K, Fowler N, Thieblemont C, Zinzani PL, Gkasiamis A, Ahn JR, Gribben JG; AUGMENT Trial Investigators. Lenalidomide Plus Rituximab for Relapsed/Refractory Indolent Non-Hodgkin Lymphoma: 5-Year Follow-Up and Subgroup Analyses From the Phase III AUGMENT Trial. J Clin Oncol. 2026 Jun;44(16):1483-1489. doi: 10.1200/JCO-25-01770. Epub 2026 Apr 16.

    PubMed 41990300

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab and Lenalidomide in people with Lymphoma, Non-Hodgkin, run by Celgene at 160 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 160 sites in United States, China, Italy, Japan, Spain and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01938001, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.

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