A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Cluster of differentiation 20 (CD20)-positive, follicular Non-Hodgkin's lymphoma grade 1, 2, 3a. A tumor biopsy must have been performed within 6 months before study entry with material available for central review
- No prior treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria:
- Grade 3b follicular lymphoma
- Transformation to high-grade lymphoma secondary to follicular lymphoma
- Types of Non-Hodgkin's lymphoma other than follicular lymphoma
- Presence or history of central nervous system (CNS) disease
- Corticoid therapy during the last 4 weeks, except prednisone treatment less than (<) 20 milligrams per day (mg per day)
- Known active bacterial, viral, fungal, or mycobacterial, or any major episode of infections requiring hospitalization or treatment with IV antibiotics within 4 weeks of start of study medication, or oral antibiotics within 2 weeks prior to start of study medication
Sites / Locations
- Gosford Hospital; Cancer Care Services
- Wollongong Hospital; Cancer Services
- Royal Brisbane and Women's Hospital
- Gold Coast Hospital; Haematology Department
- Queen Elizabeth Hospital; Haematology
- UZ Antwerpen
- CHU Sart-Tilman
- Sint Augustinus Wilrijk
- University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept
- University Clinical Center Sarajevo, Clinic for Hematology
- University Clinical Centre Tuzla, Clinic for Oncology, Hematology and Radiotherapy
- Nucleo de Hematologia e Transplante de Medula Ossea de Minas Gerais
- Hospital das Clinicas - UFRGS
- Hospital Sao Lucas - PUCRS
- Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia
- Hospital das Clinicas - FMUSP
- UMHAT Dr Georgi Stranski; Hematology
- Umhat S. George; Hematology
- Specialised Hospital For Treatment Of Hematological Diseases; Hematology
- Mhat Sveta Marina; Dept. of Haematology
- Queen Elizabeth II Health Sciences Centre; Oncology
- Cite de La Sante de Laval; Hemato-Oncologie
- Centre de sante et de services sociaux Rimouski Neigette
- Centre Hospitalier Universitaire de Sherbrooke
- Centre hospitalier regional de Trois-Rivieres
- CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie
- Fundacion Cardioinfantil
- Centro Medico Imbanaco
- Hospital Pablo Tobon Uribe
- Oncólogos de Occidente
- UHC Rijeka
- University Hospital Center Zagreb; Haematology Department
- Herlev Uni Hospital; Hæmatologisk Afdeling L 121
- Rigshospitalet; Hæmatologisk Klinik
- Odense Universitetshospital; Hæmatologisk Afdeling
- Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
- Vejle Hospital; Dept of Medicine, Division of Hematology
- Aarhus Universitetshospital, Hæmatologisk Afdeling R
- Helsinki University Central Hospital; Dept of Oncology
- Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
- Hopital Henri Mondor; Hematologie Clinique
- Chu Site Du Bocage;Hematologie Clinique
- Clinique Victor Hugo; Chimiotherapie
- Institut J Paolii Calmettes; Onco Hematologie 1
- Hopital Saint Eloi; Hematologie Oncologie Medicale
- Hopital Hotel Dieu Et Hme;Hopital De Jour
- Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
- Hopital De Haut Leveque; Hematologie Clinique
- Ch Lyon Sud; Hemato Secteur Jules Courmont
- Hopital De La Miletrie; Hematologie Et Oncologie Medicale
- Hopital Bretonneau; Hematologie Therapie Cellulaire
- M.Zodelava's Hematology Center
- Mediclub
- Institute of Hematology and Transfusiology
- Chemotherapy and Immunotherapy Clinic Medulla
- Onkologische Schwerpunktpraxis Kurfürstendamm
- Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie
- Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin
- PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann
- Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I
- Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
- Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.
- Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
- St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2
- UKSH Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie
- Gemeinschaftspraxis PD Dr. med. Marcel Reiser und Dr. med. Ildiko Kátay
- Onkologische Gemeinschaftspraxis
- Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
- Medizinisches Versorgungszentrum MOP
- Praxis Dr.med. Jens Uhlig
- Praxis Dr. Clemens Müller-Naendrup (Onkologische Schwerpunktpraxis im MVZ 2 GmbH)
- Prosper-Hospital, Medizinische Klinik I
- Praxis Dr. Fenchel
- Caritas Kilinik St. Theresia; Abt. Innere Medizin
- Praxis für Hämatologie & Onkologie
- Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
- Attiko Hospital; Haematology Clinic
- Azienda Ospedaliera Ospedale S.Carlo; Ematologia
- A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
- AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
- Ospedale S. Eugenio; Divisione Di Ematologia
- Uni Degli Studi Di Genova; 1A Divisione Di Ematologia
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
- Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia
- IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
- Ospedale Ca Foncello; Ematologia
- Ospedale Di Vicenza; Nefrologia, Ematologia
- University Clinic for Hematology; HSCT Department
- University Clinic of Hematology Skopje, Hospital Care Department
- University Malaya Medical Center; Hematology Unit of Department of Internal Medicine
- Ampang Hospital; Department of Haematology
- Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
- Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
- Hospital General De Culiacan; Servicio De Hematologia
- Hospital Universitario Dr. Jose E. Gonzalez; Haematology
- Centro de Estudios Clinicos de Queretaro (CECLIQ)
- Canterbury Health Laboratories; Haematology
- Palmerston North Hospital; Regional Cancer Treatment Service
- Instituto;Oncologico Miraflores
- Oncosalud Sac; Oncología
- Hospital Maria Auxiliadora
- Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie
- Fundeni Clinical Inst. ; Hematology Dept
- Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie
- Institutul Regional de Oncologie Iasi; Clinica de Hematologie
- Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
- Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
- Clinical Oncology Dispensary of Ministry of Health of Tatarstan
- N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
- Haematology Research Center; Haematology
- Penza Regional Oncology Dispensary
- St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
- Research Inst. of Hematology & Blood Transfusion ; Hematology
- Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology
- Institute of Hematology
- Clinical Center Vojvodine; Clinic for Hematology
- National University Hospital; National University Cancer Institute, Singapore (NCIS)
- Singapore General Hospital; Department of Haematology
- National Cancer Centre; Medical Oncology
- St. Elisabeths Cancer Center
- National Cancer Inst. ; Dept. of Chemotherapy
- National Hospital; Oncotherapy Dept
- King Edward VIII; Department of Haematology
- Durban Oncology Center
- University of Witwatersrand/Johannesburg Hospital; Dept. of ocnology
- Cancercare
- Hospital Universitario Puerta del Mar; Servicio de Hematologia
- Hospital del Mar; Servicio de Hematologia
- Hospital Universitari Vall d'Hebron; Servicio de Hematologia
- Hospital Clínic i Provincial; Servicio de Hematología y Oncología
- Hospital Duran i Reynals; Servicio de Hematologia
- Hospital Universitario de la Princesa; Servicio de Hematologia
- Hospital Ramon y Cajal; Servicio de Hematologia
- Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia
- Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
- Hospital Universitario Virgen del Rocio; Servicio de Hematologia
- Hospital Universitario la Fe; Servicio de Oncologia
- National Cancer Inst.
- Siriraj Hospital; Division of Hematology, Department of Medicine
- Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
- Adana Baskent University Hospital; Medical Oncology
- Istanbul University Cerrahpasa Medical Faculty; Hematology Department
- Bilim University School of Medicine; Hematology
- Dokuz Eylul Uni ; Hematology
- Ege Uni Medical School; Hematology
- Ninewells Hospital & Medical School; Ward 34
- Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
- Derriford Hospital; Department of Haematology
- Queen's Hospital; Oncology
- Southampton General Hospital
- Pinderfields General Hospital; Dept of Haematology
- New Cross Hospital; Dept. Of Haematology
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)
Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or cyclophosphamide, vincristine, prednisolone (CVP) chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.