Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) (AUGMENT)
Lymphoma, Non-Hodgkin
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
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
Experimental
Active Comparator
Rituximab and Lenalidomide
Rituximab and Placebo
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.