AzTrials
AzTrials

Lymphoma, Large B-Cell, DiffusePhase 3NCT01649856

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

A Phase 3 study testing CHOP and rituximab [MabThera/Rituxan] in people with Lymphoma, Large B-Cell, Diffuse, run by Hoffmann-La Roche at 186 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lymphoma, Large B-Cell, Diffuse
What is being tested?
CHOP and rituximab [MabThera/Rituxan]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
572 participants
Where
186 sitesin 27 countries
Study dates
24 Aug 2012to 16 Sep 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

186 sites in 27 countries.

186 sites in 27 countries

Italy20 sites

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

    Aviano, Friuli Venezia Giulia, 33081

  • ASST PAPA GIOVANNI XXIII; Ematologia

    Bergamo, Lombardy, 24127

  • Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.

    Cagliari, Sardinia, 09121

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

    Cremona, Lombardy, 26100

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

    Meldola, Emilia-Romagna, 47014

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

    Messina, Sicily, 98123

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

    Padova, Veneto, 35128

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

    Palermo, Sicily, 90146

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

    Perugia, Umbria, 06156

  • Ospedale Civile; S.C. Ematologia

    Pesaro, The Marches, 61100

  • Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia

    Pescara, Abruzzo, 65100

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

    Ravenna, Emilia-Romagna, 48100

  • Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

    Rimini, Emilia-Romagna, 47900

  • Uni Cattolica; Divisione Di Ematologia

    Rome, Lazio, 00168

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

    Rome, Lazio, 00189

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

    Taranto, Apulia, 74100

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

    Torrette Di Ancona, The Marches, 60020

  • AOU Ospedali Riuniti; Ematologia

    Trieste, Friuli Venezia Giulia, 34125

  • Ospedale Mauriziano Umberto I

    Turin, Piedmont, 10128

  • Ospedale Di Circolo E Fondazione Macchi; Ematologia

    Varese, Lombardy, 21100

Other trials in Italy

Spain20 sites

  • Hospital Punta Europa; Servicio de Hematologia

    Algeciras, Cadiz, 11207

  • Hospital General Univ. de Alicante; Servicio de Oncologia

    Alicante, 3010

  • Hospital de Cruces; Servicio de Hematologia

    Barakaldo, Vizcaya, 48903

  • Hospital de Donostia; Servicio de Hematologia

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital de Cabueñes; Servicio de Hematología y Hemoterapia

    Gijón, Principality of Asturias, 33203

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

    Girona, 17007

  • Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

    Las Palmas de Gran Canaria, Las Palmas, 35020

  • Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Hematologia

    Las Palmas de Gran Canarias, Las Palmas, 35016

  • Hospital Lucus Augusti; Servicio de Hematologia

    Lugo, 27003

  • Hospital General Universitario Gregorio Marañon; Servicio de Hematología

    Madrid, 28007

  • Hospital Univ. 12 de Octubre; Servicio de Hematologia

    Madrid, 28041

  • Hospital Universitario la Paz; Servicio de Hematologia

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia

    Madrid, 28222

  • Hospital Costa del Sol; Servicio de Hematologia

    Málaga, 29600

  • Corporacio Sanitaria Parc Tauli; Servicio de Hematologia

    Sabadell, Barcelona, 08208

  • Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

    Santander, Cantabria, 39008

  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

    Valencia, 46010

  • Hospital Universitario Dr. Peset; Servicio de Hematologia

    Valencia, 46017

  • Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet; Servicio Hematologia

    Zaragoza, 50009

Other trials in Spain

Netherlands16 sites

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD

  • Meander Medisch Centrum; Locatie Lichtenberg

    Amersfoort, 3818 ES

  • Deventer Ziekenhuis; Interne Geneeskunde

    Deventer, 7416 SE

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3371 NM

  • Maxima Medisch Centrum; Inwendige Geneeskunde

    Eindhoven, 5631 BM

  • Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde

    Gouda, 2803 HH

  • Universitair Medisch Centrum Groningen

    Groningen, 9700 RB

  • Atrium Medisch Centrum

    Heerlen, 6419 PC

  • Spaarne Ziekenhuis; Inwendige Geneeskunde

    Hoofddorp, 2134 TM

  • Medisch Centrum Leeuwarden; Interne

    Leeuwarden, 8934 AD

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3430 EM

  • Erasmus Mc - Locatie Centrum; Dept of Hematology

    Rotterdam, 3015 CE

  • Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed

    Rotterdam, 3075EA

  • Maasstad ziekenhuis

    Rotterdam, 3078 HT

  • Zuyderland ziekenhuis locatie Geleen

    Sittard-Geleen, 6162 BG

  • Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde

    Zwolle, 8025 AB

Other trials in Netherlands

Turkey (Türkiye)12 sites

  • Cukurova Uni ; Hematology

    Adana, 01330

  • Diskapi Research And Training Hospital; hematology

    Ankara, 06000

  • Hacettepe Uni Medical Faculty; Hematology

    Ankara, 06100

  • Ankara University; Hematology

    Ankara, 06620

  • Gaziantep Uni Medical School; Hematology

    Gaziantep, 27310

  • Istanbul University Cerrahpasa Medical Faculty; Hematology Department

    Istanbul, 34098

  • Dokuz Eylul Uni ; Hematology

    Izmir, 35100

  • Ege Uni Medical School; Hematology

    Izmir, 35100

  • Erciyes Uni ; Hematology

    Kayseri, 38039

  • Ondokuzmayis University Medical Faculty Heamatology Department

    Samsun, 55139

  • Cumhuriyet Uni. Med. Fac.; Hematology

    Sivas, 58140

  • Karadeniz Technical Uni School of Medicine; Hematology

    Trabzon, 61800

Other trials in Turkey (Türkiye)

Belgium11 sites

  • Onze Lieve Vrouwziekenhuis Aalst

    Aalst, 9300

  • ZNA Middelheim

    Antwerp, 2020

  • CHU Brugmann (Victor Horta)

    Brussels, 1020

  • Clin Univ de Bxl Hôpital Erasme

    Brussels, 1070

  • CHU Charleroi-ISPPC-Espace Santé

    Charleroi, 6000

  • CHU de Charleroi

    Charleroi, 6000

  • GHdC Site Notre Dame

    Charleroi, 6000

  • UZ Gent

    Ghent, 9000

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

  • AZ Turnhout Sint Elisabeth

    Turnhout, 2300

  • CHR de Verviers - East Belgium

    Verviers, 4800

Other trials in Belgium

Canada10 sites

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

    Barrie, Ontario, L4M 6M2

  • William Osler Health System Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

  • Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G 1G3

  • Regional health authority A vitalite health network

    Moncton, New Brunswick, E1C 8X3

  • Southlake Regional Health Center; Community Care Clinic / Oncology

    Newmarket, Ontario, L3Y 2P9

  • Lion'S Gate Hospital

    North Vancouver, British Columbia, V7L 2L7

  • Toronto East General Hospital; Haematology/Oncology

    Toronto, Ontario, M4C 3E7

  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept

    Toronto, Ontario, M5G 2M9

  • Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

France10 sites

  • Ch Victor Dupouy; Hematologie

    Argenteuil, 95107

  • Hopital Augustin Morvan; Hematologie

    Brest, 29609

  • Ch Du Mans; Medecine Hematologie Oncologie

    Le Mans, 72037

  • Centre ONCOGARD - Institut de Cancerologie du Gard

    Nîmes, 30029

  • Hopital Yves Le Foll; Hematologie Oncologie

    Saint-Brieuc, 22027

  • Ch De Saint Quentin; Medecine B10

    Saint-Quentin, 02321

  • Hopital Sud; Hematologie Clinique

    Salouël, 80480

  • Clinique Ste Anne

    Strasbourg, 67000

  • Hopital Hautepierre; Hematologie Oncologie

    Strasbourg, 67098

  • Hia Sainte Anne; Medecine Interne Oncologie

    Toulon, 83041

Other trials in France

Russia10 sites

  • Regional Oncology Center

    Chelyabinsk, 454087

  • Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

    Kazan', 420029

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

    Moscow, 115478

  • Rus Med Academy for Postgraduate Education; Oncology Department

    Moscow, 123995

  • Vladimirskiy Regional Scientific Research Inst. ; Hematology

    Moscow, 129110

  • Regional Clinical Hospital N.A. Semashko; Hematology

    Nizhny Novgorod, 603126

  • Clinical MSCh No1

    Perm, 614077

  • Saint-Petersburg SHI City Clinical Hospital #31

    Saint Petersburg, 197110

  • City Clinical Hospital #15; Hematology department

    Saint Petersburg, 198205

  • Central City Hospital #7; Hematology

    Yekaterinburg, 620137

Other trials in Russia

Greece9 sites

  • University General Hospital of Alexandroupolis; Haemotology

    Alexandroupoli, 68100

  • General Hospital of Athens Evangelismos; Hematology

    Athens, 106 76

  • Laiko General Hospital; Hematology Clinic

    Athens, 115 27

  • Metropolitan Hospital; Hematology Dept

    Athens, 18547

  • Periph. University General Hospital of Heraklion; Hematology

    Heraklion, 711 10

  • University Hospital of Ioannina; Hematology

    Ioannina, 455 00

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

    Pátrai, 265 00

  • Theagenio Anticancer Hospital; Dept. of Haematology

    Thessaloniki, 54007

  • Georgios Papanikolaou Hospital; Hematology Department

    Thessaloniki, 570 10

Other trials in Greece

Israel9 sites

  • Haemek Medical Center; Hematology Department

    Afula, 18101

  • Rambam Medical Center; Heamatology & Bone Marrow Transplantation

    Haifa, 3109601

  • Wolfson Mc; Haematology

    Holon, 5810001

  • Shaare Zedek Medical Center; Hematology Dept.

    Jerusalem, 9103102

  • Meir Medical Center; Heamatology Dept

    Kfar Saba, 4428164

  • Beilinson Medical Center; Haematology

    Petah Tikva, 49100

  • Chaim Sheba Medical Center; Hematology BMT & CBB

    Ramat Gan, 52662

  • Kaplan Medical Center

    Rehovot, 7661041

  • Ichilov Sourasky Medical Center; Heamatology

    Tel Aviv, 6423906

Other trials in Israel

Brazil6 sites

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336-550

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-080

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

    Porto Alegre, Rio Grande do Sul, 90470340

  • Instituto Nacional de Cancer - INCa; Oncologia

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Clinicas Oncologicas Integradas - COI

    Rio de Janeiro, Rio de Janeiro, 22290-160

  • Hospital das Clinicas - FMUSP; Hematologia

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Poland6 sites

  • Katedra i Klinika Hematologii i Transplantacji Szpiku SUM

    Katowice, 40-032

  • Swietokrzyskie Centrum Onkologii; Onkologia Ogolna

    Kielce, 25-734

  • Malopolskie Centrum Medyczne

    Krakow, 30-510

  • Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej

    Opole, 45-061

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

    Słupsk, 76-200

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

    Warsaw, 02-781

Other trials in Poland

Finland5 sites

  • Helsinki University Central Hospital; Dept of Oncology

    Helsinki, 00029

  • Middle Finland Central Hospital

    Jyväskylä, 40620

  • Oulu University Hospital; Oncology

    Oulu, 90029

  • Tampere University Hospital; Dept of Oncology

    Tampere, 33520

  • Turku Uni Central Hospital; Oncology Clinics

    Turku, 20520

Other trials in Finland

Ireland5 sites

  • Cork Uni Hospital; Oncology Dept

    Cork

  • Mater Misericordiae Uni Hospital; Oncology

    Dublin, 7

  • St James' Hospital; Cancer Clinical Trials Office

    Dublin

  • Galway Uni Hospital; Oncology Dept

    Galway

  • University Hospital Limerick - Oncology

    Limerick

Other trials in Ireland

Portugal5 sites

  • HUC; Servico de Hematologia

    Coimbra, 3000-075

  • Hospital Santo Antonio dos Capuchos; Servico de Hemato-Oncologia

    Lisbon, 1150-314

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

    Lisbon, 1600

  • IPO do Porto; Servico de Onco-Hematologia

    Porto, 4200-072

  • Hospital de Sao Joao; Servico de Hematologia Clinica

    Porto, 4200-319

Other trials in Portugal

United Kingdom5 sites

  • SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre

    Bristol, BS10 5NB

  • Ipswich Hospital; Oncology Pharmacy

    Ipswich, IP4 5PD

  • Macclesfield District General Hospital

    Macclesfield, SK10 3BL

  • Kings Mill Hospital

    Sutton in Ashfield, NG17 4JL

  • Singleton Hospital: Pharmacy Department

    Swansea, SA2 8QA

Other trials in United Kingdom

Thailand4 sites

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

    Bangkok, 10330

  • Ramathibodi Hospital; Division of Hematology, Department of Medicine

    Bangkok, 10400

  • Siriraj Hospital; Division of Hematology, Department of Medicine

    Bangkok, 10700

  • Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

    Khon Kaen, 40002

Other trials in Thailand

Bulgaria3 sites

  • University Hospital Sv.Georgi Clnic of Hematology; Hematology

    Plovdiv, 4002

  • Military Medical Academy; Hematology And Oncology

    Sofia, 1431

  • UMHAT Alexandrovska EAD; Hematology

    Sofia, 1431

Other trials in Bulgaria

Peru3 sites

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

    Chiclayo, CIX

  • Instituto;Oncologico Miraflores

    Lima, 18

  • Oncosalud Sac; Oncología

    Lima, 41

Other trials in Peru

South Africa3 sites

  • National Hospital; Oncotherapy Dept

    Bloemfontein, 9301

  • Tygerberg Hospital; Haematology Department

    Cape Town, 7505

  • Steve Biko Academic Hospital; Oncology

    Pretoria, 0002

Other trials in South Africa

Ukraine3 sites

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

    Dnipropetrovsk, 49102

  • Kyiv City Clinical Oncological Center; Chemotherapy Department

    Kiev, 03115

  • State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

    Lviv, 79031

Other trials in Ukraine

Algeria2 sites

  • EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward

    Blida, 09000

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

    Tizi Ouzou, 15000

Other trials in Algeria

Argentina2 sites

  • Cemic; Haematology

    Buenos Aires, C1431FWO

  • Hospital Privado de Comunidad; Oncology

    Mar del Plata, 7600

Other trials in Argentina

Colombia2 sites

  • Clínica Imbanaco; Oncology

    Cali

  • Hospital Pablo Tobon Uribe

    Medellin-Antioquia

Other trials in Colombia

Serbia2 sites

  • Clinical Center Kragujevac;Center for Hematology

    Kragujevac, 34000

  • Clinic of Haematology Cc Nis

    Niš, 18000

Other trials in Serbia

Venezuela2 sites

  • Instituto de Oncologia y Hematologia UCV

    Caracas, 1020

  • Banco Municipal de Sangre; Hematología

    Caracas, 2122

Other trials in Venezuela

Saudi Arabia1 site

  • Riyadh Military Hospital

    Riyadh, 11159

Other trials in Saudi Arabia

About this study

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)

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.

Being tested
CHOP, rituximab [MabThera/Rituxan]
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHOPDrug

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

  • 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

  • rituximab [MabThera/Rituxan]Drug

    375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles

Study groups in NCT01649856
Study groupRoleWhat they receive
A: Rituximab SCExperimentalNot described
Receives: Drug: CHOP; Drug: rituximab [MabThera/Rituxan]
B: Rituximab IVActive comparatorNot described
Receives: Drug: CHOP; Drug: rituximab [MabThera/Rituxan]

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to approximately 4.25 years

Secondary outcomes (13)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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".

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

  5. 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".

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

  6. 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.

    Measured: Up to approximately 4.25 years

  7. 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.

    Measured: Up to approximately 4.25 years

  8. 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.

    Measured: 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)

  9. 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.

    Measured: Up to approximately 4.25 years

  10. 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.

    Measured: Up to approximately 4.25 years

  11. 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.

    Measured: Up to approximately 4.25 years

  12. Number of Deaths

    Measured: Up to approximately 4.25 years

  13. Duration of Overall Survival (OS)

    OS was defined as the time from randomization to death from any cause.

    Measured: Up to approximately 4.25 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2012 (estimated)
  2. Study start24 Aug 2012
  3. Primary completion21 Oct 2014
  4. Study completion16 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
572 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01649856
Sponsor's protocol ID
MO28107
Other IDs
2012-000669-19
Status last verified
Sep 2017
First submitted
23 Jul 2012
Last updated
11 Oct 2017

Publications

  • 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.

    PubMed 28935843

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CHOP and rituximab [MabThera/Rituxan] in people with Lymphoma, Large B-Cell, Diffuse, run by Hoffmann-La Roche at 186 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 186 sites in Italy, Spain, Netherlands, Turkey (Türkiye), Belgium and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu) (time frame: Up to approximately 4.25 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01649856, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.

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