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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

Primary Purpose

Lymphoma, Large B-Cell, Diffuse

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CHOP
rituximab [MabThera/Rituxan]
rituximab [MabThera/Rituxan]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward
  • Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie
  • Cemic; Haematology
  • Hospital Privado de Comunidad; Oncology
  • Onze Lieve Vrouwziekenhuis Aalst
  • ZNA Middelheim
  • CHU Brugmann (Victor Horta)
  • Clin Univ de Bxl Hôpital Erasme
  • CHU Charleroi-ISPPC-Espace Santé
  • CHU de Charleroi
  • GHdC Site Notre Dame
  • UZ Gent
  • Jessa Zkh (Campus Virga Jesse)
  • AZ Turnhout Sint Elisabeth
  • CHR de Verviers - East Belgium
  • Crio - Centro Regional Integrado de Oncologia
  • Instituto Nacional de Cancer - INCa; Oncologia
  • Clinicas Oncologicas Integradas - COI
  • Hospital Giovanni Battista - Mae de Deus Center; Instituto do Cancer
  • Hospital Amaral Carvalho
  • Hospital das Clinicas - FMUSP; Hematologia
  • University Hospital Sv.Georgi Clnic of Hematology; Hematology
  • Military Medical Academy; Hematology And Oncology
  • UMHAT Alexandrovska EAD; Hematology
  • Lion'S Gate Hospital
  • Cancer Care Manitoba
  • Regional health authority A vitalite health network
  • Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
  • William Osler Health System Brampton Civic Hospital
  • Grand River Regional Cancer Centre
  • Southlake Regional Health Center; Community Care Clinic / Oncology
  • Toronto East General Hospital; Haematology/Oncology
  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept
  • Windsor Regional Cancer Centre
  • Clínica Imbanaco; Oncology
  • Hospital Pablo Tobon Uribe
  • Helsinki University Central Hospital; Dept of Oncology
  • Middle Finland Central Hospital
  • Oulu University Hospital; Oncology
  • Tampere University Hospital; Dept of Oncology
  • Turku Uni Central Hospital; Oncology Clinics
  • Ch Victor Dupouy; Hematologie
  • Hopital Augustin Morvan; Hematologie
  • Ch Du Mans; Medecine Hematologie Oncologie
  • Centre ONCOGARD - Institut de Cancerologie du Gard
  • Ch De Saint Quentin; Medecine B10
  • Hopital Sud; Hematologie Clinique
  • Hopital Yves Le Foll; Hematologie Oncologie
  • Clinique Ste Anne
  • Hopital Hautepierre; Hematologie Oncologie
  • Hia Sainte Anne; Medecine Interne Oncologie
  • University General Hospital of Alexandroupolis; Haemotology
  • General Hospital of Athens Evangelismos; Hematology
  • Laiko General Hospital; Hematology Clinic
  • Metropolitan Hospital; Hematology Dept
  • Periph. University General Hospital of Heraklion; Hematology
  • University Hospital of Ioannina; Hematology
  • University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
  • Theagenio Anticancer Hospital; Dept. of Haematology
  • Georgios Papanikolaou Hospital; Hematology Department
  • Cork Uni Hospital; Oncology Dept
  • Mater Misericordiae Uni Hospital; Oncology
  • St James' Hospital; Cancer Clinical Trials Office
  • Galway Uni Hospital; Oncology Dept
  • University Hospital Limerick - Oncology
  • Haemek Medical Center; Hematology Department
  • Rambam Medical Center; Heamatology & Bone Marrow Transplantation
  • Wolfson Mc; Haematology
  • Shaare Zedek Medical Center; Hematology Dept.
  • Meir Medical Center; Heamatology Dept
  • Beilinson Medical Center; Haematology
  • Chaim Sheba Medical Center; Hematology BMT & CBB
  • Kaplan Medical Center
  • Ichilov Sourasky Medical Center; Heamatology
  • Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia
  • Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia
  • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
  • AOU Ospedali Riuniti; Ematologia
  • Uni Cattolica; Divisione Di Ematologia
  • Az. Osp. Sant'Andrea; U.O. C. Ematologia
  • ASST PAPA GIOVANNI XXIII; Ematologia
  • ASST DI CREMONA; U.O.S. di Ematologia
  • Ospedale Di Circolo E Fondazione Macchi; Ematologia
  • Ospedale Civile; S.C. Ematologia
  • A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia
  • Ospedale Mauriziano Umberto I
  • Az. Osp. G. Moscati; U.O. Do Ematologia
  • Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
  • Azienda Ospedaliero Uni Ria Policlinico G. Martino; U.O. Di Oncologia Medica
  • Casa Di Cura La Maddalena; Oncoematologia E Trapianto Del Midollo Osseo
  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
  • Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
  • Medisch Centrum Alkmaar
  • Meander Medisch Centrum; Locatie Lichtenberg
  • Deventer Ziekenhuis; Interne Geneeskunde
  • Albert Schweitzer Ziekenhuis
  • Maxima Medisch Centrum; Inwendige Geneeskunde
  • Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde
  • Universitair Medisch Centrum Groningen
  • Atrium Medisch Centrum
  • Spaarne Ziekenhuis; Inwendige Geneeskunde
  • Medisch Centrum Leeuwarden; Interne
  • St. Antonius Ziekenhuis Nieuwegein
  • Erasmus Mc - Locatie Centrum; Dept of Hematology
  • Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed
  • Maasstad ziekenhuis
  • Zuyderland ziekenhuis locatie Geleen
  • Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde
  • Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica
  • Instituto;Oncologico Miraflores
  • Oncosalud Sac; Oncología
  • Katedra i Klinika Hematologii i Transplantacji Szpiku SUM
  • Swietokrzyskie Centrum Onkologii; Onkologia Ogolna
  • Malopolskie Centrum Medyczne
  • Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej
  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny
  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
  • HUC; Servico de Hematologia
  • Hospital Santo Antonio dos Capuchos; Servico de Hemato-Oncologia
  • Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula
  • IPO do Porto; Servico de Onco-Hematologia
  • Hospital de Sao Joao; Servico de Hematologia Clinica
  • Regional Oncology Center
  • Central City Hospital #7; Hematology
  • Republican Clinical Oncologic Dispensary of Republic Of Tatarstan
  • N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
  • Rus Med Academy for Postgraduate Education; Oncology Department
  • Vladimirskiy Regional Scientific Research Inst. ; Hematology
  • Regional Clinical Hospital N.A. Semashko; Hematology
  • Clinical MSCh No1
  • City Clinical Hospital #15; Hematology department
  • Saint-Petersburg SHI City Clinical Hospital #31
  • Riyadh Military Hospital
  • Clinical Center Kragujevac;Center for Hematology
  • Clinic of Haematology Cc Nis
  • National Hospital; Oncotherapy Dept
  • Tygerberg Hospital; Haematology Department
  • Steve Biko Academic Hospital; Oncology
  • Hospital de Cabueñes; Servicio de Hematología y Hemoterapia
  • Corporacio Sanitaria Parc Tauli; Servicio de Hematologia
  • Hospital Punta Europa; Servicio de Hematologia
  • Hospital Universitario Marques de Valdecilla; Servicio de Hematologia
  • Hospital de Donostia; Servicio de Hematologia
  • Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Hematologia
  • Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
  • Hospital de Cruces; Servicio de Hematologia
  • Hospital General Univ. de Alicante; Servicio de Oncologia
  • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Hematologia
  • Hospital Lucus Augusti; Servicio de Hematologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Hematología
  • Hospital Univ. 12 de Octubre; Servicio de Hematologia
  • Hospital Universitario la Paz; Servicio de Hematologia
  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia
  • Hospital Costa del Sol; Servicio de Hematologia
  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Hospital Universitario Dr. Peset; Servicio de Hematologia
  • Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia
  • Hospital Universitario Miguel Servet; Servicio Hematologia
  • King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
  • Ramathibodi Hospital; Division of Hematology, Department of Medicine
  • Siriraj Hospital; Division of Hematology, Department of Medicine
  • Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
  • Cukurova Uni ; Hematology
  • Diskapi Research And Training Hospital; hematology
  • Hacettepe Uni Medical Faculty; Hematology
  • Ankara University; Hematology
  • Gaziantep Uni Medical School; Hematology
  • Istanbul University Cerrahpasa Medical Faculty; Hematology Department
  • Dokuz Eylul Uni ; Hematology
  • Ege Uni Medical School; Hematology
  • Erciyes Uni ; Hematology
  • Ondokuzmayis University Medical Faculty Heamatology Department
  • Cumhuriyet Uni. Med. Fac.; Hematology
  • Karadeniz Technical Uni School of Medicine; Hematology
  • Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology
  • Kyiv City Clinical Oncological Center; Chemotherapy Department
  • State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department
  • SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre
  • Ipswich Hospital; Oncology Pharmacy
  • Macclesfield District General Hospital
  • Kings Mill Hospital
  • Singleton Hospital: Pharmacy Department
  • Instituto de Oncologia y Hematologia UCV
  • Banco Municipal de Sangre; Hematología

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A: Rituximab SC

B: Rituximab IV

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores
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.
Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores
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.
Median Duration of Rituximab Administration for Each Treatment Cycle
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.
Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle
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".
Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle
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".
Number of Participants With an Event-Free Survival (EFS) Event
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.
Duration of EFS
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.
Number of Participants With Relapse or Death at the Time of Primary Analysis
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.
Duration of Disease-Free Survival (DFS)
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.
Number of Participants With Progression, Relapse, or Death
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.
Duration of Progression-Free Survival (PFS)
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.
Number of Deaths
Duration of Overall Survival (OS)
OS was defined as the time from randomization to death from any cause.

Full Information

First Posted
July 23, 2012
Last Updated
September 11, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01649856
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 24, 2012 (Actual)
Primary Completion Date
October 21, 2014 (Actual)
Study Completion Date
September 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
572 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Rituximab SC
Arm Type
Experimental
Arm Title
B: Rituximab IV
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CHOP
Intervention Description
CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles
Intervention Type
Drug
Intervention Name(s)
rituximab [MabThera/Rituxan]
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
rituximab [MabThera/Rituxan]
Intervention Description
375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu)
Description
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).
Time Frame
Up to approximately 4.25 years
Secondary Outcome Measure Information:
Title
Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores
Description
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.
Time Frame
At Cycle 7 (each cycle was 14 or 21 days)
Title
Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores
Description
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.
Time Frame
At Cycle 7 (each cycle was 14 or 21 days)
Title
Median Duration of Rituximab Administration for Each Treatment Cycle
Description
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.
Time Frame
Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
Title
Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle
Description
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".
Time Frame
Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
Title
Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle
Description
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".
Time Frame
Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
Title
Number of Participants With an Event-Free Survival (EFS) Event
Description
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.
Time Frame
Up to approximately 4.25 years
Title
Duration of EFS
Description
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.
Time Frame
Up to approximately 4.25 years
Title
Number of Participants With Relapse or Death at the Time of Primary Analysis
Description
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.
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)
Title
Duration of Disease-Free Survival (DFS)
Description
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.
Time Frame
Up to approximately 4.25 years
Title
Number of Participants With Progression, Relapse, or Death
Description
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.
Time Frame
Up to approximately 4.25 years
Title
Duration of Progression-Free Survival (PFS)
Description
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.
Time Frame
Up to approximately 4.25 years
Title
Number of Deaths
Time Frame
Up to approximately 4.25 years
Title
Duration of Overall Survival (OS)
Description
OS was defined as the time from randomization to death from any cause.
Time Frame
Up to approximately 4.25 years

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
28935843
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.
Results Reference
derived

Learn more about this trial

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

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