Clinical trial NCT01649856: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphoma, Large B-Cell, Diffuse
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-07-25
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu)
timeFrame: Up to approximately 4.25 years
Secondary outcomes:
measure: Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores
timeFrame: At Cycle 7 (each cycle was 14 or 21 days)
measure: Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores
timeFrame: At Cycle 7 (each cycle was 14 or 21 days)
measure: Median Duration of Rituximab Administration for Each Treatment Cycle
timeFrame: Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
measure: Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle
timeFrame: Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
measure: Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle
timeFrame: Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
measure: Number of Participants With an Event-Free Survival (EFS) Event
timeFrame: Up to approximately 4.25 years
measure: Duration of EFS
timeFrame: Up to approximately 4.25 years
measure: Number of Participants With Relapse or Death at the Time of Primary Analysis
timeFrame: 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)
measure: Duration of Disease-Free Survival (DFS)
timeFrame: Up to approximately 4.25 years
measure: Number of Participants With Progression, Relapse, or Death
timeFrame: Up to approximately 4.25 years
measure: Duration of Progression-Free Survival (PFS)
timeFrame: Up to approximately 4.25 years
measure: Number of Deaths
timeFrame: Up to approximately 4.25 years
measure: Duration of Overall Survival (OS)
timeFrame: Up to approximately 4.25 years
Other outcomes:
Locations:
city: Blida
country: Algeria
facility: EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward
city: Tizi Ouzou
country: Algeria
facility: Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie
city: Buenos Aires
country: Argentina
facility: Cemic; Haematology
city: Mar Del Plata
country: Argentina
facility: Hospital Privado de Comunidad; Oncology
city: Aalst
country: Belgium
facility: Onze Lieve Vrouwziekenhuis Aalst
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Bruxelles
country: Belgium
facility: CHU Brugmann (Victor Horta)
city: Bruxelles
country: Belgium
facility: Clin Univ de Bxl Hôpital Erasme
city: Charleroi
country: Belgium
facility: CHU Charleroi-ISPPC-Espace Santé
city: Charleroi
country: Belgium
facility: CHU de Charleroi
city: Charleroi
country: Belgium
facility: GHdC Site Notre Dame
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Turnhout
country: Belgium
facility: AZ Turnhout Sint Elisabeth
city: Verviers
country: Belgium
facility: CHR de Verviers - East Belgium
city: Fortaleza
country: Brazil
facility: Crio - Centro Regional Integrado de Oncologia
state: CE
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCa; Oncologia
state: RJ
city: Rio De Janeiro
country: Brazil
facility: Clinicas Oncologicas Integradas - COI
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital Giovanni Battista - Mae de Deus Center; Instituto do Cancer
state: RS
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP; Hematologia
state: SP
city: Plovdiv
country: Bulgaria
facility: University Hospital Sv.Georgi Clnic of Hematology; Hematology
city: Sofia
country: Bulgaria
facility: Military Medical Academy; Hematology And Oncology
city: Sofia
country: Bulgaria
facility: UMHAT Alexandrovska EAD; Hematology
city: North Vancouver
country: Canada
facility: Lion'S Gate Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Moncton
country: Canada
facility: Regional health authority A vitalite health network
state: New Brunswick
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
state: Ontario
city: Brampton
country: Canada
facility: William Osler Health System Brampton Civic Hospital
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Regional Cancer Centre
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Center; Community Care Clinic / Oncology
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital; Haematology/Oncology
state: Ontario
city: Toronto
country: Canada
facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
city: Cali
country: Colombia
facility: Clínica Imbanaco; Oncology
city: Medellin-Antioquia
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital; Dept of Oncology
city: Jyväskylä
country: Finland
facility: Middle Finland Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital; Oncology
city: Tampere
country: Finland
facility: Tampere University Hospital; Dept of Oncology
city: Turku
country: Finland
facility: Turku Uni Central Hospital; Oncology Clinics
city: Argenteuil
country: France
facility: Ch Victor Dupouy; Hematologie
city: Brest
country: France
facility: Hopital Augustin Morvan; Hematologie
city: Le Mans
country: France
facility: Ch Du Mans; Medecine Hematologie Oncologie
city: Nimes
country: France
facility: Centre ONCOGARD - Institut de Cancerologie du Gard
city: Saint Quentin
country: France
facility: Ch De Saint Quentin; Medecine B10
city: Salouel
country: France
facility: Hopital Sud; Hematologie Clinique
city: St Brieuc
country: France
facility: Hopital Yves Le Foll; Hematologie Oncologie
city: Strasbourg
country: France
facility: Clinique Ste Anne
city: Strasbourg
country: France
facility: Hopital Hautepierre; Hematologie Oncologie
city: Toulon
country: France
facility: Hia Sainte Anne; Medecine Interne Oncologie
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis; Haemotology
city: Athens
country: Greece
facility: General Hospital of Athens Evangelismos; Hematology
city: Athens
country: Greece
facility: Laiko General Hospital; Hematology Clinic
city: Athens
country: Greece
facility: Metropolitan Hospital; Hematology Dept
city: Heraklion
country: Greece
facility: Periph. University General Hospital of Heraklion; Hematology
city: Ioannina
country: Greece
facility: University Hospital of Ioannina; Hematology
city: Patras
country: Greece
facility: University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
city: Thessaloniki
country: Greece
facility: Theagenio Anticancer Hospital; Dept. of Haematology
city: Thessaloniki
country: Greece
facility: Georgios Papanikolaou Hospital; Hematology Department
city: Cork
country: Ireland
facility: Cork Uni Hospital; Oncology Dept
city: Dublin
country: Ireland
facility: Mater Misericordiae Uni Hospital; Oncology
city: Dublin
country: Ireland
facility: St James' Hospital; Cancer Clinical Trials Office
city: Galway
country: Ireland
facility: Galway Uni Hospital; Oncology Dept
city: Limerick
country: Ireland
facility: University Hospital Limerick - Oncology
city: Afula
country: Israel
facility: Haemek Medical Center; Hematology Department
city: Haifa
country: Israel
facility: Rambam Medical Center; Heamatology & Bone Marrow Transplantation
city: Holon
country: Israel
facility: Wolfson Mc; Haematology
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center; Hematology Dept.
city: Kfar Saba
country: Israel
facility: Meir Medical Center; Heamatology Dept
city: Petach Tikva
country: Israel
facility: Beilinson Medical Center; Haematology
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Hematology BMT & CBB
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Ichilov Sourasky Medical Center; Heamatology
city: Pescara
country: Italy
facility: Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
state: Abruzzo
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
state: Friuli-Venezia Giulia
city: Trieste
country: Italy
facility: AOU Ospedali Riuniti; Ematologia
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Uni Cattolica; Divisione Di Ematologia
state: Lazio
city: Roma
country: Italy
facility: Az. Osp. Sant'Andrea; U.O. C. Ematologia
state: Lazio
city: Bergamo
country: Italy
facility: ASST PAPA GIOVANNI XXIII; Ematologia
state: Lombardia
city: Cremona
country: Italy
facility: ASST DI CREMONA; U.O.S. di Ematologia
state: Lombardia
city: Varese
country: Italy
facility: Ospedale Di Circolo E Fondazione Macchi; Ematologia
state: Lombardia
city: Pesaro
country: Italy
facility: Ospedale Civile; S.C. Ematologia
state: Marche
city: Torrette Di Ancona
country: Italy
facility: A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia
state: Marche
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I
state: Piemonte
city: Taranto
country: Italy
facility: Az. Osp. G. Moscati; U.O. Do Ematologia
state: Puglia
city: Cagliari
country: Italy
facility: Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
state: Sardegna
city: Messina
country: Italy
facility: Azienda Ospedaliero Uni Ria Policlinico G. Martino; U.O. Di Oncologia Medica
state: Sicilia
city: Palermo
country: Italy
facility: Casa Di Cura La Maddalena; Oncoematologia E Trapianto Del Midollo Osseo
state: Sicilia
city: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
state: Umbria
city: Padova
country: Italy
facility: Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
state: Veneto
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum; Locatie Lichtenberg
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis; Interne Geneeskunde
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum; Inwendige Geneeskunde
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis; Inwendige Geneeskunde
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden; Interne
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Rotterdam
country: Netherlands
facility: Erasmus Mc - Locatie Centrum; Dept of Hematology
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed
city: Rotterdam
country: Netherlands
facility: Maasstad ziekenhuis
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland ziekenhuis locatie Geleen
city: Zwolle
country: Netherlands
facility: Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde
city: Chiclayo
country: Peru
facility: Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica
city: Lima
country: Peru
facility: Instituto;Oncologico Miraflores
city: Lima
country: Peru
facility: Oncosalud Sac; Oncología
city: Katowice
country: Poland
facility: Katedra i Klinika Hematologii i Transplantacji Szpiku SUM
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii; Onkologia Ogolna
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne
city: Opole
country: Poland
facility: Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
city: Coimbra
country: Portugal
facility: HUC; Servico de Hematologia
city: Lisboa
country: Portugal
facility: Hospital Santo Antonio dos Capuchos; Servico de Hemato-Oncologia
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Onco-Hematologia
city: Porto
country: Portugal
facility: Hospital de Sao Joao; Servico de Hematologia Clinica
city: Chelyabinsk
country: Russian Federation
facility: Regional Oncology Center
city: Ekaterinburg
country: Russian Federation
facility: Central City Hospital #7; Hematology
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncologic Dispensary of Republic Of Tatarstan
city: Moscow
country: Russian Federation
facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
city: Moscow
country: Russian Federation
facility: Rus Med Academy for Postgraduate Education; Oncology Department
city: Moscow
country: Russian Federation
facility: Vladimirskiy Regional Scientific Research Inst. ; Hematology
city: Nizhny Novgorod
country: Russian Federation
facility: Regional Clinical Hospital N.A. Semashko; Hematology
city: Perm
country: Russian Federation
facility: Clinical MSCh No1
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Hospital #15; Hematology department
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg SHI City Clinical Hospital #31
city: Riyadh
country: Saudi Arabia
facility: Riyadh Military Hospital
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac;Center for Hematology
city: NIS
country: Serbia
facility: Clinic of Haematology Cc Nis
city: Bloemfontein
country: South Africa
facility: National Hospital; Oncotherapy Dept
city: Cape Town
country: South Africa
facility: Tygerberg Hospital; Haematology Department
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital; Oncology
city: Gijon
country: Spain
facility: Hospital de Cabueñes; Servicio de Hematología y Hemoterapia
state: Asturias
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli; Servicio de Hematologia
state: Barcelona
city: Algeciras
country: Spain
facility: Hospital Punta Europa; Servicio de Hematologia
state: Cadiz
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia
state: Cantabria
city: San Sebastian
country: Spain
facility: Hospital de Donostia; Servicio de Hematologia
state: Guipuzcoa
city: Las Palmas de Gran Canarias
country: Spain
facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Hematologia
state: Las Palmas
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
state: Las Palmas
city: Barakaldo
country: Spain
facility: Hospital de Cruces; Servicio de Hematologia
state: Vizcaya
city: Alicante
country: Spain
facility: Hospital General Univ. de Alicante; Servicio de Oncologia
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Hematologia
city: Lugo
country: Spain
facility: Hospital Lucus Augusti; Servicio de Hematologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Hematología
city: Madrid
country: Spain
facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia
city: Madrid
country: Spain
facility: Hospital Universitario la Paz; Servicio de Hematologia
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Costa del Sol; Servicio de Hematologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset; Servicio de Hematologia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio Hematologia
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital; Division of Hematology, Department of Medicine
city: Bangkok
country: Thailand
facility: Siriraj Hospital; Division of Hematology, Department of Medicine
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
city: Adana
country: Turkey
facility: Cukurova Uni ; Hematology
city: Ankara
country: Turkey
facility: Diskapi Research And Training Hospital; hematology
city: Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty; Hematology
city: Ankara
country: Turkey
facility: Ankara University; Hematology
city: Gaziantep
country: Turkey
facility: Gaziantep Uni Medical School; Hematology
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty; Hematology Department
city: Izmir
country: Turkey
facility: Dokuz Eylul Uni ; Hematology
city: Izmir
country: Turkey
facility: Ege Uni Medical School; Hematology
city: Kayseri
country: Turkey
facility: Erciyes Uni ; Hematology
city: Samsun
country: Turkey
facility: Ondokuzmayis University Medical Faculty Heamatology Department
city: Sivas
country: Turkey
facility: Cumhuriyet Uni. Med. Fac.; Hematology
city: Trabzon
country: Turkey
facility: Karadeniz Technical Uni School of Medicine; Hematology
city: Dnipropetrovsk
country: Ukraine
facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology
city: Kiev
country: Ukraine
facility: Kyiv City Clinical Oncological Center; Chemotherapy Department
city: Lviv
country: Ukraine
facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department
city: Bristol
country: United Kingdom
facility: SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital; Oncology Pharmacy
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
city: Sutton in Ashfield
country: United Kingdom
facility: Kings Mill Hospital
city: Swansea
country: United Kingdom
facility: Singleton Hospital: Pharmacy Department
city: Caracas
country: Venezuela
facility: Instituto de Oncologia y Hematologia UCV
city: Caracas
country: Venezuela
facility: Banco Municipal de Sangre; Hematología
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.