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

NCT01649856 | Completed Phase 3 Results

• 2 other identifiers: MO281072012-000669-19
• Study Type: interventional
• Target: 572
• Locations: 27 countries
• Sites: 186

Brief Summary

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.

Conditions

Lymphoma, Large B-Cell, Diffuse

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu)

  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 Outcomes (13)

• Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores

  At Cycle 7 (each cycle was 14 or 21 days)

• Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores

  At Cycle 7 (each cycle was 14 or 21 days)

• Median Duration of Rituximab Administration for Each Treatment Cycle

  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

  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

  Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)

Study Arms (2)

A: Rituximab SC

EXPERIMENTAL

Drug: CHOP; Drug: rituximab [MabThera/Rituxan]

B: Rituximab IV

ACTIVE COMPARATOR

Drug: CHOP; Drug: rituximab [MabThera/Rituxan]

Interventions

CHOP DRUG

CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles

A: Rituximab SC; B: Rituximab IV

rituximab [MabThera/Rituxan] DRUG

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

A: Rituximab SC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (186)

EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward

Blida, 09000, Algeria

Location

Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie

Tizi Ouzou, 15000, Algeria

Location

Cemic; Haematology

Buenos Aires, C1431FWO, Argentina

Location

Hospital Privado de Comunidad; Oncology

Mar del Plata, 7600, Argentina

Location

Onze Lieve Vrouwziekenhuis Aalst

Aalst, 9300, Belgium

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

CHU Brugmann (Victor Horta)

Brussels, 1020, Belgium

Location

Clin Univ de Bxl Hôpital Erasme

Brussels, 1070, Belgium

Location

CHU Charleroi-ISPPC-Espace Santé

Charleroi, 6000, Belgium

Location

CHU de Charleroi

Charleroi, 6000, Belgium

Location

GHdC Site Notre Dame

Charleroi, 6000, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Jessa Zkh (Campus Virga Jesse)

Hasselt, 3500, Belgium

Location

AZ Turnhout Sint Elisabeth

Turnhout, 2300, Belgium

Location

CHR de Verviers - East Belgium

Verviers, 4800, Belgium

Location

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, 60336-550, Brazil

Location

Instituto Nacional de Cancer - INCa; Oncologia

Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil

Location

Clinicas Oncologicas Integradas - COI

Rio de Janeiro, Rio de Janeiro, 22290-160, Brazil

Location

Hospital Giovanni Battista - Mae de Deus Center; Instituto do Cancer

Porto Alegre, Rio Grande do Sul, 90470340, Brazil

Location

Hospital Amaral Carvalho

Jaú, São Paulo, 17210-080, Brazil

Location

Hospital das Clinicas - FMUSP; Hematologia

São Paulo, São Paulo, 05403-000, Brazil

Location

University Hospital Sv.Georgi Clnic of Hematology; Hematology

Plovdiv, 4002, Bulgaria

Location

Military Medical Academy; Hematology And Oncology

Sofia, 1431, Bulgaria

Location

UMHAT Alexandrovska EAD; Hematology

Sofia, 1431, Bulgaria

Location

Lion'S Gate Hospital

North Vancouver, British Columbia, V7L 2L7, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Regional health authority A vitalite health network

Moncton, New Brunswick, E1C 8X3, Canada

Location

Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

Barrie, Ontario, L4M 6M2, Canada

Location

William Osler Health System Brampton Civic Hospital

Brampton, Ontario, L6R 3J7, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

Location

Southlake Regional Health Center; Community Care Clinic / Oncology

Newmarket, Ontario, L3Y 2P9, Canada

Location

Toronto East General Hospital; Haematology/Oncology

Toronto, Ontario, M4C 3E7, Canada

Location

University Health Network; Princess Margaret Hospital; Medical Oncology Dept

Toronto, Ontario, M5G 2M9, Canada

Location

Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

Clínica Imbanaco; Oncology

Cali, Colombia

Location

Hospital Pablo Tobon Uribe

Medellin-Antioquia, Colombia

Location

Helsinki University Central Hospital; Dept of Oncology

Helsinki, 00029, Finland

Location

Middle Finland Central Hospital

Jyväskylä, 40620, Finland

Location

Oulu University Hospital; Oncology

Oulu, 90029, Finland

Location

Tampere University Hospital; Dept of Oncology

Tampere, 33520, Finland

Location

Turku Uni Central Hospital; Oncology Clinics

Turku, 20520, Finland

Location

Ch Victor Dupouy; Hematologie

Argenteuil, 95107, France

Location

Hopital Augustin Morvan; Hematologie

Brest, 29609, France

Location

Ch Du Mans; Medecine Hematologie Oncologie

Le Mans, 72037, France

Location

Centre ONCOGARD - Institut de Cancerologie du Gard

Nîmes, 30029, France

Location

Hopital Yves Le Foll; Hematologie Oncologie

Saint-Brieuc, 22027, France

Location

Ch De Saint Quentin; Medecine B10

Saint-Quentin, 02321, France

Location

Hopital Sud; Hematologie Clinique

Salouël, 80480, France

Location

Clinique Ste Anne

Strasbourg, 67000, France

Location

Hopital Hautepierre; Hematologie Oncologie

Strasbourg, 67098, France

Location

Hia Sainte Anne; Medecine Interne Oncologie

Toulon, 83041, France

Location

University General Hospital of Alexandroupolis; Haemotology

Alexandroupoli, 68100, Greece

Location

General Hospital of Athens Evangelismos; Hematology

Athens, 106 76, Greece

Location

Laiko General Hospital; Hematology Clinic

Athens, 115 27, Greece

Location

Metropolitan Hospital; Hematology Dept

Athens, 18547, Greece

Location

Periph. University General Hospital of Heraklion; Hematology

Heraklion, 711 10, Greece

Location

University Hospital of Ioannina; Hematology

Ioannina, 455 00, Greece

Location

University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division

Pátrai, 265 00, Greece

Location

Theagenio Anticancer Hospital; Dept. of Haematology

Thessaloniki, 54007, Greece

Location

Georgios Papanikolaou Hospital; Hematology Department

Thessaloniki, 570 10, Greece

Location

Cork Uni Hospital; Oncology Dept

Cork, Ireland

Location

Mater Misericordiae Uni Hospital; Oncology

Dublin, 7, Ireland

Location

St James' Hospital; Cancer Clinical Trials Office

Dublin, Ireland

Location

Galway Uni Hospital; Oncology Dept

Galway, Ireland

Location

University Hospital Limerick - Oncology

Limerick, Ireland

Location

Haemek Medical Center; Hematology Department

Afula, 18101, Israel

Location

Rambam Medical Center; Heamatology & Bone Marrow Transplantation

Haifa, 3109601, Israel

Location

Wolfson Mc; Haematology

Holon, 5810001, Israel

Location

Shaare Zedek Medical Center; Hematology Dept.

Jerusalem, 9103102, Israel

Location

Meir Medical Center; Heamatology Dept

Kfar Saba, 4428164, Israel

Location

Beilinson Medical Center; Haematology

Petah Tikva, 49100, Israel

Location

Chaim Sheba Medical Center; Hematology BMT & CBB

Ramat Gan, 52662, Israel

Location

Kaplan Medical Center

Rehovot, 7661041, Israel

Location

Ichilov Sourasky Medical Center; Heamatology

Tel Aviv, 6423906, Israel

Location

Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia

Pescara, Abruzzo, 65100, Italy

Location

Az. Osp. G. Moscati; U.O. Do Ematologia

Taranto, Apulia, 74100, Italy

Location

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

Meldola, Emilia-Romagna, 47014, Italy

Location

Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

Ravenna, Emilia-Romagna, 48100, Italy

Location

Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

Rimini, Emilia-Romagna, 47900, Italy

Location

Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

Aviano, Friuli Venezia Giulia, 33081, Italy

Location

AOU Ospedali Riuniti; Ematologia

Trieste, Friuli Venezia Giulia, 34125, Italy

Location

Uni Cattolica; Divisione Di Ematologia

Rome, Lazio, 00168, Italy

Location

Az. Osp. Sant'Andrea; U.O. C. Ematologia

Rome, Lazio, 00189, Italy

Location

ASST PAPA GIOVANNI XXIII; Ematologia

Bergamo, Lombardy, 24127, Italy

Location

ASST DI CREMONA; U.O.S. di Ematologia

Cremona, Lombardy, 26100, Italy

Location

Ospedale Di Circolo E Fondazione Macchi; Ematologia

Varese, Lombardy, 21100, Italy

Location

Ospedale Mauriziano Umberto I

Turin, Piedmont, 10128, Italy

Location

Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.

Cagliari, Sardinia, 09121, Italy

Location

Azienda Ospedaliero Uni Ria Policlinico G. Martino; U.O. Di Oncologia Medica

Messina, Sicily, 98123, Italy

Location

Casa Di Cura La Maddalena; Oncoematologia E Trapianto Del Midollo Osseo

Palermo, Sicily, 90146, Italy

Location

Ospedale Civile; S.C. Ematologia

Pesaro, The Marches, 61100, Italy

Location

A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia

Torrette Di Ancona, The Marches, 60020, Italy

Location

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

Perugia, Umbria, 06156, Italy

Location

Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia

Padua, Veneto, 35128, Italy

Location

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

Meander Medisch Centrum; Locatie Lichtenberg

Amersfoort, 3818 ES, Netherlands

Location

Deventer Ziekenhuis; Interne Geneeskunde

Deventer, 7416 SE, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, 3371 NM, Netherlands

Location

Maxima Medisch Centrum; Inwendige Geneeskunde

Eindhoven, 5631 BM, Netherlands

Location

Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde

Gouda, 2803 HH, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9700 RB, Netherlands

Location

Atrium Medisch Centrum

Heerlen, 6419 PC, Netherlands

Location

Spaarne Ziekenhuis; Inwendige Geneeskunde

Hoofddorp, 2134 TM, Netherlands

Location

Medisch Centrum Leeuwarden; Interne

Leeuwarden, 8934 AD, Netherlands

Location

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, 3430 EM, Netherlands

Location

Erasmus Mc - Locatie Centrum; Dept of Hematology

Rotterdam, 3015 CE, Netherlands

Location

Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed

Rotterdam, 3075EA, Netherlands

Location

Maasstad ziekenhuis

Rotterdam, 3078 HT, Netherlands

Location

Zuyderland ziekenhuis locatie Geleen

Sittard-Geleen, 6162 BG, Netherlands

Location

Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde

Zwolle, 8025 AB, Netherlands

Location

Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica

Chiclayo, CIX, Peru

Location

Instituto;Oncologico Miraflores

Lima, 18, Peru

Location

Oncosalud Sac; Oncología

Lima, 41, Peru

Location

Katedra i Klinika Hematologii i Transplantacji Szpiku SUM

Katowice, 40-032, Poland

Location

Swietokrzyskie Centrum Onkologii; Onkologia Ogolna

Kielce, 25-734, Poland

Location

Malopolskie Centrum Medyczne

Krakow, 30-510, Poland

Location

Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej

Opole, 45-061, Poland

Location

Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny

Słupsk, 76-200, Poland

Location

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

Warsaw, 02-781, Poland

Location

HUC; Servico de Hematologia

Coimbra, 3000-075, Portugal

Location

Hospital Santo Antonio dos Capuchos; Servico de Hemato-Oncologia

Lisbon, 1150-314, Portugal

Location

Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula

Lisbon, 1600, Portugal

Location

IPO do Porto; Servico de Onco-Hematologia

Porto, 4200-072, Portugal

Location

Hospital de Sao Joao; Servico de Hematologia Clinica

Porto, 4200-319, Portugal

Location

Regional Oncology Center

Chelyabinsk, 454087, Russia

Location

Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

Kazan', 420029, Russia

Location

N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

Moscow, 115478, Russia

Location

Rus Med Academy for Postgraduate Education; Oncology Department

Moscow, 123995, Russia

Location

Vladimirskiy Regional Scientific Research Inst. ; Hematology

Moscow, 129110, Russia

Location

Regional Clinical Hospital N.A. Semashko; Hematology

Nizhny Novgorod, 603126, Russia

Location

Clinical MSCh No1

Perm, 614077, Russia

Location

Saint-Petersburg SHI City Clinical Hospital #31

Saint Petersburg, 197110, Russia

Location

City Clinical Hospital #15; Hematology department

Saint Petersburg, 198205, Russia

Location

Central City Hospital #7; Hematology

Yekaterinburg, 620137, Russia

Location

Riyadh Military Hospital

Riyadh, 11159, Saudi Arabia

Location

Clinical Center Kragujevac;Center for Hematology

Kragujevac, 34000, Serbia

Location

Clinic of Haematology Cc Nis

Niš, 18000, Serbia

Location

National Hospital; Oncotherapy Dept

Bloemfontein, 9301, South Africa

Location

Tygerberg Hospital; Haematology Department

Cape Town, 7505, South Africa

Location

Steve Biko Academic Hospital; Oncology

Pretoria, 0002, South Africa

Location

Corporacio Sanitaria Parc Tauli; Servicio de Hematologia

Sabadell, Barcelona, 08208, Spain

Location

Hospital Punta Europa; Servicio de Hematologia

Algeciras, Cadiz, 11207, Spain

Location

Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

Santander, Cantabria, 39008, Spain

Location

Hospital de Donostia; Servicio de Hematologia

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

Las Palmas de Gran Canaria, Las Palmas, 35020, Spain

Location

Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Hematologia

Las Palmas de Gran Canarias, Las Palmas, 35016, Spain

Location

Hospital de Cabueñes; Servicio de Hematología y Hemoterapia

Gijón, Principality of Asturias, 33203, Spain

Location

Hospital de Cruces; Servicio de Hematologia

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital General Univ. de Alicante; Servicio de Oncologia

Alicante, 3010, Spain

Location

Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Hematologia

Girona, 17007, Spain

Location

Hospital Lucus Augusti; Servicio de Hematologia

Lugo, 27003, Spain

Location

Hospital General Universitario Gregorio Marañon; Servicio de Hematología

Madrid, 28007, Spain

Location

Hospital Univ. 12 de Octubre; Servicio de Hematologia

Madrid, 28041, Spain

Location

Hospital Universitario la Paz; Servicio de Hematologia

Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro; Servicio de Oncologia

Madrid, 28222, Spain

Location

Hospital Costa del Sol; Servicio de Hematologia

Málaga, 29600, Spain

Location

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Valencia, 46010, Spain

Location

Hospital Universitario Dr. Peset; Servicio de Hematologia

Valencia, 46017, Spain

Location

Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet; Servicio Hematologia

Zaragoza, 50009, Spain

Location

King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine

Bangkok, 10330, Thailand

Location

Ramathibodi Hospital; Division of Hematology, Department of Medicine

Bangkok, 10400, Thailand

Location

Siriraj Hospital; Division of Hematology, Department of Medicine

Bangkok, 10700, Thailand

Location

Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

Khon Kaen, 40002, Thailand

Location

Cukurova Uni ; Hematology

Adana, 01330, Turkey (Türkiye)

Location

Diskapi Research And Training Hospital; hematology

Ankara, 06000, Turkey (Türkiye)

Location

Hacettepe Uni Medical Faculty; Hematology

Ankara, 06100, Turkey (Türkiye)

Location

Ankara University; Hematology

Ankara, 06620, Turkey (Türkiye)

Location

Gaziantep Uni Medical School; Hematology

Gaziantep, 27310, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty; Hematology Department

Istanbul, 34098, Turkey (Türkiye)

Location

Dokuz Eylul Uni ; Hematology

Izmir, 35100, Turkey (Türkiye)

Location

Ege Uni Medical School; Hematology

Izmir, 35100, Turkey (Türkiye)

Location

Erciyes Uni ; Hematology

Kayseri, 38039, Turkey (Türkiye)

Location

Ondokuzmayis University Medical Faculty Heamatology Department

Samsun, 55139, Turkey (Türkiye)

Location

Cumhuriyet Uni. Med. Fac.; Hematology

Sivas, 58140, Turkey (Türkiye)

Location

Karadeniz Technical Uni School of Medicine; Hematology

Trabzon, 61800, Turkey (Türkiye)

Location

Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology

Dnipropetrovsk, 49102, Ukraine

Location

Kyiv City Clinical Oncological Center; Chemotherapy Department

Kiev, 03115, Ukraine

Location

State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

Lviv, 79031, Ukraine

Location

SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre

Bristol, BS10 5NB, United Kingdom

Location

Ipswich Hospital; Oncology Pharmacy

Ipswich, IP4 5PD, United Kingdom

Location

Macclesfield District General Hospital

Macclesfield, SK10 3BL, United Kingdom

Location

Kings Mill Hospital

Sutton in Ashfield, NG17 4JL, United Kingdom

Location

Singleton Hospital: Pharmacy Department

Swansea, SA2 8QA, United Kingdom

Location

Instituto de Oncologia y Hematologia UCV

Caracas, 1020, Venezuela

Location

Banco Municipal de Sangre; Hematología

Caracas, 2122, Venezuela

Location

Related Publications (1)

• Lugtenburg P, Avivi I, Berenschot H, Ilhan O, Marolleau JP, Nagler A, Rueda A, Tani M, Turgut M, Osborne S, Smith R, Pfreundschuh M. Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study. Haematologica. 2017 Nov;102(11):1913-1922. doi: 10.3324/haematol.2017.173583. Epub 2017 Sep 21.

  PMID: 28935843 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 25, 2012
• Study Start: August 24, 2012
• Primary Completion: October 21, 2014
• Study Completion: September 16, 2016
• Last Updated: October 11, 2017
• Results First Posted: February 12, 2016

Record last verified: 2017-09

Locations

AR (2); PL (6); SE (2); ZA (3); ES (20); PT (5); BE (11); IE (5); BU (3); NL (16); CA (10); VE (2); UA (3); IT (20); CO (2); FI (5); SA (1); TH (4); PE (3); BR (6); GR (9); TU (12); FR (10); GB (5); RU (10); AL (2); IL (9)