A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma

September 11, 2017 updated by: Hoffmann-La Roche

A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)

This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

572

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

  • Algeria
      • Blida, Algeria, 09000
        • EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward
      • Tizi Ouzou, Algeria, 15000
        • Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie
  • Argentina
      • Buenos Aires, Argentina, C1431FWO
        • Cemic; Haematology
      • Mar Del Plata, Argentina, 7600
        • Hospital Privado de Comunidad; Oncology
  • Belgium
      • Aalst, Belgium, 9300
        • Onze Lieve Vrouwziekenhuis Aalst
      • Antwerpen, Belgium, 2020
        • ZNA Middelheim
      • Bruxelles, Belgium, 1020
        • CHU Brugmann (Victor Horta)
      • Bruxelles, Belgium, 1070
        • Clin Univ de Bxl Hôpital Erasme
      • Charleroi, Belgium, 6000
        • GHdC Site Notre Dame
      • Charleroi, Belgium, 6000
        • CHU de Charleroi
      • Charleroi, Belgium, 6000
        • CHU Charleroi-ISPPC-Espace Santé
      • Gent, Belgium, 9000
        • UZ Gent
      • Hasselt, Belgium, 3500
        • Jessa Zkh (Campus Virga Jesse)
      • Turnhout, Belgium, 2300
        • AZ Turnhout Sint Elisabeth
      • Verviers, Belgium, 4800
        • CHR de Verviers - East Belgium
  • Brazil
    • CE
      • Fortaleza, CE, Brazil, 60336-550
        • Crio - Centro Regional Integrado de Oncologia
    • RJ
      • Rio De Janeiro, RJ, Brazil, 22290-160
        • Clinicas Oncologicas Integradas - COI
      • Rio de Janeiro, RJ, Brazil, 20560-120
        • Instituto Nacional de Cancer - INCa; Oncologia
    • RS
      • Porto Alegre, RS, Brazil, 90470340
        • Hospital Giovanni Battista - Mae de Deus Center; Instituto do Cancer
    • SP
      • Jau, SP, Brazil, 17210-080
        • Hospital Amaral Carvalho
      • Sao Paulo, SP, Brazil, 05403-000
        • Hospital das Clinicas - FMUSP; Hematologia
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • University Hospital Sv.Georgi Clnic of Hematology; Hematology
      • Sofia, Bulgaria, 1431
        • UMHAT Alexandrovska EAD; Hematology
      • Sofia, Bulgaria, 1431
        • Military Medical Academy; Hematology And Oncology
  • Canada
    • British Columbia
      • North Vancouver, British Columbia, Canada, V7L 2L7
        • Lion's Gate Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Cancer Care Manitoba
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
        • Regional health authority A vitalite health network
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health System Brampton Civic Hospital
      • Kitchener, Ontario, Canada, N2G 1G3
        • Grand River Regional Cancer Centre
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Center; Community Care Clinic / Oncology
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital; Haematology/Oncology
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network; Princess Margaret Hospital; Medical Oncology Dept
      • Windsor, Ontario, Canada, N8W 2X3
        • Windsor Regional Cancer Centre
  • Colombia
      • Cali, Colombia
        • Clínica Imbanaco; Oncology
      • Medellin-Antioquia, Colombia
        • Hospital Pablo Tobon Uribe
  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital; Dept of Oncology
      • Jyväskylä, Finland, 40620
        • Middle Finland Central Hospital
      • Oulu, Finland, 90029
        • Oulu University Hospital; Oncology
      • Tampere, Finland, 33520
        • Tampere University Hospital; Dept of Oncology
      • Turku, Finland, 20520
        • Turku Uni Central Hospital; Oncology Clinics
  • France
      • Argenteuil, France, 95107
        • Ch Victor Dupouy; Hematologie
      • Brest, France, 29609
        • Hopital Augustin Morvan; Hematologie
      • Le Mans, France, 72037
        • Ch Du Mans; Medecine Hematologie Oncologie
      • Nimes, France, 30029
        • Centre ONCOGARD - Institut de cancérologie du Gard
      • Saint Quentin, France, 02321
        • Ch De Saint Quentin; Medecine B10
      • Salouel, France, 80480
        • Hopital Sud; Hematologie Clinique
      • St Brieuc, France, 22027
        • Hopital Yves Le Foll; Hematologie Oncologie
      • Strasbourg, France, 67000
        • Clinique Ste Anne
      • Strasbourg, France, 67098
        • Hopital Hautepierre; Hematologie Oncologie
      • Toulon, France, 83041
        • Hia Sainte Anne; Medecine Interne Oncologie
  • Greece
      • Alexandroupolis, Greece, 68100
        • University General Hospital of Alexandroupolis; Haemotology
      • Athens, Greece, 106 76
        • General Hospital of Athens Evangelismos; Hematology
      • Athens, Greece, 115 27
        • Laiko General Hospital; Hematology Clinic
      • Athens, Greece, 18547
        • Metropolitan Hospital; Hematology Dept
      • Heraklion, Greece, 711 10
        • Periph. University General Hospital of Heraklion; Hematology
      • Ioannina, Greece, 455 00
        • University Hospital of Ioannina; Hematology
      • Patras, Greece, 265 00
        • University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
      • Thessaloniki, Greece, 54007
        • Theagenio Anticancer Hospital; Dept. of Haematology
      • Thessaloniki, Greece, 570 10
        • Georgios Papanikolaou Hospital; Hematology Department
  • Ireland
      • Cork, Ireland
        • Cork Uni Hospital; Oncology Dept
      • Dublin, Ireland, 7
        • Mater Misericordiae Uni Hospital; Oncology
      • Dublin, Ireland
        • St James' Hospital; Cancer Clinical Trials Office
      • Galway, Ireland
        • Galway Uni Hospital; Oncology Dept
      • Limerick, Ireland
        • University Hospital Limerick - Oncology
  • Israel
      • Afula, Israel, 18101
        • Haemek Medical Center; Hematology Department
      • Haifa, Israel, 3109601
        • Rambam Medical Center; Heamatology & Bone Marrow Transplantation
      • Holon, Israel, 5810001
        • Wolfson Mc; Haematology
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center; Hematology Dept.
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center; Heamatology Dept
      • Petach Tikva, Israel, 49100
        • Beilinson Medical Center; Haematology
      • Ramat Gan, Israel, 52662
        • Chaim Sheba Medical Center; Hematology BMT & CBB
      • Rehovot, Israel, 7661041
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423906
        • Ichilov Sourasky Medical Center; Heamatology
  • Italy
    • Abruzzo
      • Pescara, Abruzzo, Italy, 65100
        • Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
      • Ravenna, Emilia-Romagna, Italy, 48100
        • Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia
      • Rimini, Emilia-Romagna, Italy, 47900
        • Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia
    • Friuli-Venezia Giulia
      • Aviano, Friuli-Venezia Giulia, Italy, 33081
        • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
      • Trieste, Friuli-Venezia Giulia, Italy, 34125
        • AOU Ospedali Riuniti; Ematologia
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Uni Cattolica; Divisione Di Ematologia
      • Roma, Lazio, Italy, 00189
        • Az. Osp. Sant'Andrea; U.O. C. Ematologia
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
        • ASST PAPA GIOVANNI XXIII; Ematologia
      • Cremona, Lombardia, Italy, 26100
        • ASST DI CREMONA; U.O.S. di Ematologia
      • Varese, Lombardia, Italy, 21100
        • Ospedale Di Circolo E Fondazione Macchi; Ematologia
    • Marche
      • Pesaro, Marche, Italy, 61100
        • Ospedale Civile; S.C. Ematologia
      • Torrette Di Ancona, Marche, Italy, 60020
        • A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia
    • Piemonte
      • Torino, Piemonte, Italy, 10128
        • Ospedale Mauriziano Umberto I
    • Puglia
      • Taranto, Puglia, Italy, 74100
        • Az. Osp. G. Moscati; U.O. Do Ematologia
    • Sardegna
      • Cagliari, Sardegna, Italy, 09121
        • Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
    • Sicilia
      • Messina, Sicilia, Italy, 98123
        • Azienda Ospedaliero Uni Ria Policlinico G. Martino; U.O. Di Oncologia Medica
      • Palermo, Sicilia, Italy, 90146
        • Casa Di Cura La Maddalena; Oncoematologia E Trapianto Del Midollo Osseo
    • Umbria
      • Perugia, Umbria, Italy, 06156
        • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Medisch Centrum Alkmaar
      • Amersfoort, Netherlands, 3818 ES
        • Meander Medisch Centrum; Locatie Lichtenberg
      • Deventer, Netherlands, 7416 SE
        • Deventer Ziekenhuis; Interne Geneeskunde
      • Dordrecht, Netherlands, 3371 NM
        • Albert Schweitzer Ziekenhuis
      • Eindhoven, Netherlands, 5631 BM
        • Maxima Medisch Centrum; Inwendige Geneeskunde
      • Gouda, Netherlands, 2803 HH
        • Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde
      • Groningen, Netherlands, 9700 RB
        • Universitair Medisch Centrum Groningen
      • Heerlen, Netherlands, 6419 PC
        • Atrium medisch centrum
      • Hoofddorp, Netherlands, 2134 TM
        • Spaarne Ziekenhuis; Inwendige Geneeskunde
      • Leeuwarden, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden; Interne
      • Nieuwegein, Netherlands, 3430 EM
        • St. Antonius Ziekenhuis Nieuwegein
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Mc - Locatie Centrum; Dept of Hematology
      • Rotterdam, Netherlands, 3075EA
        • Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed
      • Rotterdam, Netherlands, 3078 HT
        • Maasstad Ziekenhuis
      • Sittard-Geleen, Netherlands, 6162 BG
        • Zuyderland ziekenhuis locatie Geleen
      • Zwolle, Netherlands, 8025 AB
        • Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde
  • Peru
      • Chiclayo, Peru, CIX
        • Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica
      • Lima, Peru, 18
        • Instituto;Oncologico Miraflores
      • Lima, Peru, 41
        • Oncosalud Sac; Oncología
  • Poland
      • Katowice, Poland, 40-032
        • Katedra i Klinika Hematologii i Transplantacji Szpiku SUM
      • Kielce, Poland, 25-734
        • Swietokrzyskie Centrum Onkologii; Onkologia Ogolna
      • Krakow, Poland, 30-510
        • Malopolskie Centrum Medyczne
      • Opole, Poland, 45-061
        • Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej
      • Slupsk, Poland, 76-200
        • Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny
      • Warszawa, Poland, 02-781
        • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
  • Portugal
      • Coimbra, Portugal, 3000-075
        • HUC; Servico de Hematologia
      • Lisboa, Portugal, 1150-314
        • Hospital Santo Antonio dos Capuchos; Servico de Hemato-Oncologia
      • Lisboa, Portugal, 1600
        • Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula
      • Porto, Portugal, 4200-072
        • IPO do Porto; Servico de Onco-Hematologia
      • Porto, Portugal, 4200-319
        • Hospital de Sao Joao; Servico de Hematologia Clinica
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • Regional Oncology Center
      • Ekaterinburg, Russian Federation, 620137
        • Central City Hospital #7; Hematology
      • Kazan, Russian Federation, 420029
        • Republican Clinical Oncologic Dispensary of Republic Of Tatarstan
      • Moscow, Russian Federation, 129110
        • Vladimirskiy Regional Scientific Research Inst. ; Hematology
      • Moscow, Russian Federation, 115478
        • N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
      • Moscow, Russian Federation, 123995
        • Rus Med Academy for Postgraduate Education; Oncology Department
      • Nizhny Novgorod, Russian Federation, 603126
        • Regional Clinical Hospital N.A. Semashko; Hematology
      • Perm, Russian Federation, 614077
        • Clinical MSCh No1
      • Saint-Petersburg, Russian Federation, 198205
        • City Clinical Hospital #15; Hematology department
      • St. Petersburg, Russian Federation, 197110
        • Saint-Petersburg SHI City Clinical Hospital #31
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11159
        • Riyadh Military Hospital
  • Serbia
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac;Center for Hematology
      • NIS, Serbia, 18000
        • Clinic of Haematology Cc Nis
  • South Africa
      • Bloemfontein, South Africa, 9301
        • National Hospital; Oncotherapy Dept
      • Cape Town, South Africa, 7505
        • Tygerberg Hospital; Haematology Department
      • Pretoria, South Africa, 0002
        • Steve Biko Academic Hospital; Oncology
  • Spain
      • Alicante, Spain, 3010
        • Hospital General Univ. de Alicante; Servicio de Oncologia
      • Girona, Spain, 17007
        • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Hematologia
      • Lugo, Spain, 27003
        • Hospital Lucus Augusti; Servicio de Hematologia
      • Madrid, Spain, 28046
        • Hospital Universitario la Paz; Servicio de Hematologia
      • Madrid, Spain, 28041
        • Hospital Univ. 12 de Octubre; Servicio de Hematologia
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro; Servicio de Oncologia
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon; Servicio de Hematología
      • Malaga, Spain, 29600
        • Hospital Costa del Sol; Servicio de Hematologia
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
      • Valencia, Spain, 46017
        • Hospital Universitario Dr. Peset; Servicio de Hematologia
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet; Servicio Hematologia
    • Asturias
      • Gijon, Asturias, Spain, 33203
        • Hospital de Cabueñes; Servicio de Hematología y Hemoterapia
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli; Servicio de Hematologia
    • Cadiz
      • Algeciras, Cadiz, Spain, 11207
        • Hospital Punta Europa; Servicio de Hematologia
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla; Servicio de Hematologia
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20014
        • Hospital de Donostia; Servicio de Hematologia
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35020
        • Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
      • Las Palmas de Gran Canarias, Las Palmas, Spain, 35016
        • Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Hematologia
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital de Cruces; Servicio de Hematologia
  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital; Division of Hematology, Department of Medicine
      • Bangkok, Thailand, 10700
        • Siriraj Hospital; Division of Hematology, Department of Medicine
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
  • Turkey
      • Adana, Turkey, 01330
        • Cukurova Uni ; Hematology
      • Ankara, Turkey, 06100
        • Hacettepe Uni Medical Faculty; Hematology
      • Ankara, Turkey, 06000
        • Diskapi Research And Training Hospital; hematology
      • Ankara, Turkey, 06620
        • Ankara University; Hematology
      • Gaziantep, Turkey, 27310
        • Gaziantep Uni Medical School; Hematology
      • Istanbul, Turkey, 34098
        • Istanbul University Cerrahpasa Medical Faculty; Hematology Department
      • Izmir, Turkey, 35100
        • Ege Uni Medical School; Hematology
      • Izmir, Turkey, 35100
        • Dokuz Eylul Uni ; Hematology
      • Kayseri, Turkey, 38039
        • Erciyes Uni ; Hematology
      • Samsun, Turkey, 55139
        • Ondokuzmayis University Medical Faculty Heamatology Department
      • Sivas, Turkey, 58140
        • Cumhuriyet Uni. Med. Fac.; Hematology
      • Trabzon, Turkey, 61800
        • Karadeniz Technical Uni School of Medicine; Hematology
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology
      • Kiev, Ukraine, 03115
        • Kyiv City Clinical Oncological Center; Chemotherapy Department
      • Lviv, Ukraine, 79031
        • State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital; Oncology Pharmacy
      • Macclesfield, United Kingdom, SK10 3BL
        • Macclesfield District General Hospital
      • Sutton in Ashfield, United Kingdom, NG17 4JL
        • Kings Mill Hospital
      • Swansea, United Kingdom, SA2 8QA
        • Singleton Hospital: Pharmacy Department
  • Venezuela
      • Caracas, Venezuela, 1020
        • Instituto de Oncologia y Hematologia UCV
      • Caracas, Venezuela, 2122
        • Banco Municipal de Sangre; Hematología

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, >/= 18 and </= 80 years of age at time of study inclusion
  • Histologically confirmed, previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) according to the WHO classification system
  • Patients with an International Prognostic Index (IPI) score 1-5, or IPI score 0 with bulky disease, defined as one lesion >/= 7.5 cm
  • At least one bi-dimensionally measurable lesion defined as >/= 1.5 cm in its largest dimension on CT scan, PET-CT scan or MRI
  • Adequate hematologic function
  • Eastern Cooperative Oncology Group (EOCD) performance status </= 2

Exclusion Criteria:

  • Primary or secondary central nervous system lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis
  • Transformed lymphoma or follicular lymphoma IIIB
  • Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
  • History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for >/= 5 years prior to enrolment
  • Inadequate renal or hepatic function
  • Known human immunodeficiency virus (HIV) infection or HIV seropositive status
  • Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. Patients with occult or prior HBV infection as defined by protocol may be included. Patients positive for HCV antibody are eligible only if polymerase chain reaction testing for HCV ribonucleic acid is negative.
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
  • Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
  • Prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
  • Pregnant or lactating women

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: Rituximab SC
Drug: CHOP
CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles
Drug: rituximab [MabThera/Rituxan]
The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles
Drug: rituximab [MabThera/Rituxan]
375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles
Active Comparator: B: Rituximab IV
Drug: CHOP
CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles
Drug: rituximab [MabThera/Rituxan]
The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles
Drug: rituximab [MabThera/Rituxan]
375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu)
Time Frame: Up to approximately 4.25 years
Tumor response was assessed per criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by greater than (>) 75 percent (%) but still >1.5 centimeters (cm) in size, and indeterminate bone marrow assessment. The percentage of participants with either response at the end of induction (EOI) was determined with corresponding 95% Pearson-Clopper confidence interval (CI).
Up to approximately 4.25 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores
Time Frame: At Cycle 7 (each cycle was 14 or 21 days)
The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.
At Cycle 7 (each cycle was 14 or 21 days)
Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores
Time Frame: At Cycle 7 (each cycle was 14 or 21 days)
The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.
At Cycle 7 (each cycle was 14 or 21 days)
Median Duration of Rituximab Administration for Each Treatment Cycle
Time Frame: Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
Duration of rituximab administration was defined as the time from start to end of the SC injection or IV infusion. The median duration was reported.
Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle
Time Frame: Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
Chair time was defined as the amount of time the participant occupied an infusion chair/bed for a single treatment cycle of rituximab + CHOP chemotherapy. Where the chair time was not documented for a given cycle, it was reported as "Missing".
Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle
Time Frame: Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
Hospital time was defined as the amount of time the participant was in the hospital for the course of one cycle of rituximab + CHOP chemotherapy. Where the hospital time was not documented for a given cycle, it was reported as "Missing".
Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
Number of Participants With an Event-Free Survival (EFS) Event
Time Frame: Up to approximately 4.25 years
EFS events included disease progression, relapse, initiation of other anti-lymphoma therapy, or death. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as greater than or equal to (≥) 50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.
Up to approximately 4.25 years
Duration of EFS
Time Frame: Up to approximately 4.25 years
EFS was defined as the time from randomization to first occurrence of disease progression, relapse, initiation of other anti-lymphoma therapy, or death, whichever occurred first. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as a ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.
Up to approximately 4.25 years
Number of Participants With Relapse or Death at the Time of Primary Analysis
Time Frame: Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination)
Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu. The number of participants who had experienced relapse or death prior to the clinical cut-off date (October 2014) was determined.
Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination)
Duration of Disease-Free Survival (DFS)
Time Frame: Up to approximately 4.25 years
DFS was defined as the time from date of initial CR/CRu to the date of relapse or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.
Up to approximately 4.25 years
Number of Participants With Progression, Relapse, or Death
Time Frame: Up to approximately 4.25 years
Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.
Up to approximately 4.25 years
Duration of Progression-Free Survival (PFS)
Time Frame: Up to approximately 4.25 years
PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.
Up to approximately 4.25 years
Number of Deaths
Time Frame: Up to approximately 4.25 years
Up to approximately 4.25 years
Duration of Overall Survival (OS)
Time Frame: Up to approximately 4.25 years
OS was defined as the time from randomization to death from any cause.
Up to approximately 4.25 years

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Publications and helpful links

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General Publications

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)

August 24, 2012

Primary Completion (Actual)

October 21, 2014

Study Completion (Actual)

September 16, 2016

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (Estimate)

July 25, 2012

Study Record Updates

Last Update Posted (Actual)

October 11, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO28107
  • 2012-000669-19 (EudraCT Number)

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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