A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma

NCT01200758 | Completed Phase 3 Results DMC

• 2 other identifiers: BO223342010-021377-36
• Study Type: interventional
• Target: 410
• Locations: 30 countries
• Sites: 152

Brief Summary

This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m\^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (2)

• Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab

  Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)

• Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL)

  Overall Response comprised complete response (CR), CR unconfirmed (CRu), or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and computed tomography (CT) scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by more than (\>) 75% in the sum of the products of greatest diameters (SPD); PR: Greater than or equal to (≥) 50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.

  Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

Secondary Outcomes (24)

• Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL

  Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

• Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL

  Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

• Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL

  Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

• Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL

  Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

• Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL

  Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

Study Arms (2)

Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)

ACTIVE COMPARATOR

Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or cyclophosphamide, vincristine, prednisolone (CVP) chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.

Drug: Rituximab IV; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone/Prednisolone

Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)

EXPERIMENTAL

First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.

Drug: Rituximab SC; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone/Prednisolone

Interventions

Rituximab SC DRUG

First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.

Also known as: MabThera

Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)

Rituximab IV DRUG

Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.

Also known as: MabThera

Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)

Cyclophosphamide DRUG

Eight cycles of cyclophosphamide (750 mg/m\^2 IV) administered every 3 weeks.

Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP); Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)

Doxorubicin DRUG

Eight cycles of doxorubicin (50 mg/m\^2 IV) administered every 3 weeks.

Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP); Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)

Vincristine DRUG

Eight cycles of doxorubicin (1.4 mg/m\^2 IV) administered every 3 weeks.

Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP); Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)

Prednisone/Prednisolone DRUG

Eight cycles of prednisone/prednisolone (100 mg/day or 40 mg/m\^2/day IV/orally) administered Days 1 to 5 of every 21 days cycle.

Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP); Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)

Eligibility Criteria

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

You may qualify if:

• Cluster of differentiation 20 (CD20)-positive, follicular Non-Hodgkin's lymphoma grade 1, 2, 3a. A tumor biopsy must have been performed within 6 months before study entry with material available for central review
• No prior treatment
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

You may not qualify if:

• Grade 3b follicular lymphoma
• Transformation to high-grade lymphoma secondary to follicular lymphoma
• Types of Non-Hodgkin's lymphoma other than follicular lymphoma
• Presence or history of central nervous system (CNS) disease
• Corticoid therapy during the last 4 weeks, except prednisone treatment less than (\<) 20 milligrams per day (mg per day)
• Known active bacterial, viral, fungal, or mycobacterial, or any major episode of infections requiring hospitalization or treatment with IV antibiotics within 4 weeks of start of study medication, or oral antibiotics within 2 weeks prior to start of study medication

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (152)

Gosford Hospital; Cancer Care Services

Gosford, New South Wales, 2250, Australia

Location

Wollongong Hospital; Cancer Services

Wollongong, New South Wales, 2500, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Gold Coast Hospital; Haematology Department

Southport, Queensland, 4215, Australia

Location

Queen Elizabeth Hospital; Haematology

Woodville South, South Australia, 5011, Australia

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

CHU Sart-Tilman

Liège, 4000, Belgium

Location

Sint Augustinus Wilrijk

Wilrijk, 2610, Belgium

Location

University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept

Banja Luka, 88000, Bosnia and Herzegovina

Location

University Clinical Center Sarajevo, Clinic for Hematology

Sarajevo, 71000, Bosnia and Herzegovina

Location

University Clinical Centre Tuzla, Clinic for Oncology, Hematology and Radiotherapy

Tuzla, 75000, Bosnia and Herzegovina

Location

Nucleo de Hematologia e Transplante de Medula Ossea de Minas Gerais

Belo Horizonte, Minas Gerais, 30140-001, Brazil

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia

São Paulo, São Paulo, 01221-020, Brazil

Location

Hospital das Clinicas - FMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

UMHAT Dr Georgi Stranski; Hematology

Pleven, 5800, Bulgaria

Location

Umhat S. George; Hematology

Plovdiv, 4002, Bulgaria

Location

Specialised Hospital For Treatment Of Hematological Diseases; Hematology

Sofia, 1756, Bulgaria

Location

Mhat Sveta Marina; Dept. of Haematology

Varna, 9010, Bulgaria

Location

Queen Elizabeth II Health Sciences Centre; Oncology

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Cite de La Sante de Laval; Hemato-Oncologie

Laval, Quebec, H7M 3L9, Canada

Location

Centre de sante et de services sociaux Rimouski Neigette

Rimouski, Quebec, G5L 5T1, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Centre hospitalier regional de Trois-Rivieres

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie

Québec, G1J 1Z4, Canada

Location

Fundacion Cardioinfantil

Bogotá, Colombia

Location

Centro Medico Imbanaco

Cali, Colombia

Location

Hospital Pablo Tobon Uribe

Medellin-Antioquia, Colombia

Location

Oncólogos de Occidente

Pereira, 600004, Colombia

Location

UHC Rijeka

Rijeka, 51000, Croatia

Location

University Hospital Center Zagreb; Haematology Department

Zagreb, 10000, Croatia

Location

Aarhus Universitetshospital, Hæmatologisk Afdeling R

Aarhus, 8000, Denmark

Location

Herlev Uni Hospital; Hæmatologisk Afdeling L 121

Herlev, 2730, Denmark

Location

Rigshospitalet; Hæmatologisk Klinik

København Ø, 2100, Denmark

Location

Odense Universitetshospital; Hæmatologisk Afdeling

Odense C, 5000, Denmark

Location

Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

Roskilde, 4000, Denmark

Location

Vejle Hospital; Dept of Medicine, Division of Hematology

Vejle, 7100, Denmark

Location

Helsinki University Central Hospital; Dept of Oncology

Helsinki, 00029, Finland

Location

Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

Bordeaux, 33077, France

Location

Hopital Henri Mondor; Hematologie Clinique

Créteil, 94010, France

Location

Chu Site Du Bocage;Hematologie Clinique

Dijon, 21079, France

Location

Clinique Victor Hugo; Chimiotherapie

Le Mans, 72015, France

Location

Institut J Paolii Calmettes; Onco Hematologie 1

Marseille, 13273, France

Location

Hopital Saint Eloi; Hematologie Oncologie Medicale

Montpellier, 34295, France

Location

Hopital Hotel Dieu Et Hme;Hopital De Jour

Nantes, 44093, France

Location

Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

Paris, 75475, France

Location

Hopital De Haut Leveque; Hematologie Clinique

Pessac, 33604, France

Location

Ch Lyon Sud; Hemato Secteur Jules Courmont

Pierre-Bénite, 69495, France

Location

Hopital De La Miletrie; Hematologie Et Oncologie Medicale

Poitiers, 86021, France

Location

Hopital Bretonneau; Hematologie Therapie Cellulaire

Tours, 37044, France

Location

M.Zodelava's Hematology Center

Tbilisi, 0112, Georgia

Location

Mediclub

Tbilisi, 0160, Georgia

Location

Institute of Hematology and Transfusiology

Tbilisi, 0177, Georgia

Location

Chemotherapy and Immunotherapy Clinic Medulla

Tbilisi, 0186, Georgia

Location

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, 10707, Germany

Location

Gemeinschaftspraxis PD Dr. med. Marcel Reiser und Dr. med. Ildiko Kátay

Cologne, 50674, Germany

Location

Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie

Darmstadt, 64283, Germany

Location

Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin

Dresden, 01307, Germany

Location

PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann

Frechen, 50226, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I

Giessen, 35392, Germany

Location

Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

Greifswald, 17475, Germany

Location

Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.

Halle, 06110, Germany

Location

Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

Hanover, 30625, Germany

Location

St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2

Karlsruhe, 76137, Germany

Location

UKSH Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie

Kiel, 24105, Germany

Location

Onkologische Gemeinschaftspraxis

Magdeburg, 39104, Germany

Location

Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

Marburg, 35037, Germany

Location

Medizinisches Versorgungszentrum MOP

München, 80335, Germany

Location

Praxis Dr.med. Jens Uhlig

Naunhof, 04683, Germany

Location

Praxis Dr. Clemens Müller-Naendrup (Onkologische Schwerpunktpraxis im MVZ 2 GmbH)

Olpe, 57462, Germany

Location

Prosper-Hospital, Medizinische Klinik I

Recklinghausen, 45659, Germany

Location

Praxis Dr. Fenchel

Saalfeld, 07318, Germany

Location

Caritas Kilinik St. Theresia; Abt. Innere Medizin

Saarbrücken, 66113, Germany

Location

Praxis für Hämatologie & Onkologie

Saarbrücken, 66113, Germany

Location

Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

Athens, 115 27, Greece

Location

Attiko Hospital; Haematology Clinic

Athens, 124 62, Greece

Location

IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo

San Giovanni Rotondo, Apulia, 71013, Italy

Location

Azienda Ospedaliera Ospedale S.Carlo; Ematologia

Potenza, Basilicate, 85100, Italy

Location

A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica

Napoli, Campania, 80131, Italy

Location

AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia

Reggio Emilia, Emilia-Romagna, 42100, Italy

Location

Ospedale S. Eugenio; Divisione Di Ematologia

Rome, Lazio, 00144, Italy

Location

Uni Degli Studi Di Genova; 1A Divisione Di Ematologia

Genoa, Liguria, 16132, Italy

Location

A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

Brescia, Lombardy, 25123, Italy

Location

Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia

Milan, Lombardy, 20141, Italy

Location

Ospedale Ca Foncello; Ematologia

Treviso, Veneto, 31100, Italy

Location

Ospedale Di Vicenza; Nefrologia, Ematologia

Vicenza, Veneto, 36100, Italy

Location

University Malaya Medical Center; Hematology Unit of Department of Internal Medicine

Kuala Lumpur, FED. Territory of Kuala Lumpur, 59100, Malaysia

Location

Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

Sarawak, Sarawak, 93586, Malaysia

Location

Ampang Hospital; Department of Haematology

Ampang, 68000, Malaysia

Location

Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

Chihuahua City, 31000, Mexico

Location

Hospital General De Culiacan; Servicio De Hematologia

Culiacán, 80230, Mexico

Location

Hospital Universitario Dr. Jose E. Gonzalez; Haematology

Monterrey, 64460, Mexico

Location

Centro de Estudios Clinicos de Queretaro (CECLIQ)

Querétaro, 76000, Mexico

Location

Canterbury Health Laboratories; Haematology

Christchurch, 8011, New Zealand

Location

Palmerston North Hospital; Regional Cancer Treatment Service

Palmerston North, 4442, New Zealand

Location

University Clinic for Hematology; HSCT Department

Skopje, 1000, North Macedonia

Location

University Clinic of Hematology Skopje, Hospital Care Department

Skopje, 1000, North Macedonia

Location

Instituto;Oncologico Miraflores

Lima, 18, Peru

Location

Oncosalud Sac; Oncología

Lima, 41, Peru

Location

Hospital Maria Auxiliadora

Lima, Lima 29, Peru

Location

Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie

Brasov, 500326, Romania

Location

Fundeni Clinical Inst. ; Hematology Dept

Bucharest, 022328, Romania

Location

Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie

Iași, 700111, Romania

Location

Institutul Regional de Oncologie Iasi; Clinica de Hematologie

Iași, 700483, Romania

Location

Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

Târgu Mureş, 540136, Romania

Location

Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie

Timișoara, 300079, Romania

Location

Clinical Oncology Dispensary of Ministry of Health of Tatarstan

Kazan', 420029, Russia

Location

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

Moscow, 115478, Russia

Location

Haematology Research Center; Haematology

Moscow, 125167, Russia

Location

Penza Regional Oncology Dispensary

Penza, 440071, Russia

Location

Research Inst. of Hematology & Blood Transfusion ; Hematology

Saint Petersburg, 191024, Russia

Location

St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

Saint Petersburg, 197022, Russia

Location

Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology

St.Petersburg, Pesochny, 197758, Russia

Location

Institute of Hematology

Belgrade, 11000, Serbia

Location

Clinical Center Vojvodine; Clinic for Hematology

Novi Sad, 21000, Serbia

Location

National University Hospital; National University Cancer Institute, Singapore (NCIS)

Singapore, 119228, Singapore

Location

Singapore General Hospital; Department of Haematology

Singapore, 169608, Singapore

Location

National Cancer Centre; Medical Oncology

Singapore, 169610, Singapore

Location

St. Elisabeths Cancer Center

Bratislava, 812 50, Slovakia

Location

National Cancer Inst. ; Dept. of Chemotherapy

Bratislava, 833 10, Slovakia

Location

National Hospital; Oncotherapy Dept

Bloemfontein, 9301, South Africa

Location

Durban Oncology Center

Durban, 4091, South Africa

Location

University of Witwatersrand/Johannesburg Hospital; Dept. of ocnology

Johannesburg, 2193, South Africa

Location

Cancercare

Kraaifontein, 7570, South Africa

Location

King Edward VIII; Department of Haematology

KwaKhangela, 4013, South Africa

Location

Hospital Universitario Puerta del Mar; Servicio de Hematologia

Cadiz, Cadiz, 11009, Spain

Location

Hospital del Mar; Servicio de Hematologia

Barcelona, 08003, Spain

Location

Hospital Universitari Vall d'Hebron; Servicio de Hematologia

Barcelona, 08035, Spain

Location

Hospital Clínic i Provincial; Servicio de Hematología y Oncología

Barcelona, 08036, Spain

Location

Hospital Duran i Reynals; Servicio de Hematologia

Barcelona, 08907, Spain

Location

Hospital Universitario de la Princesa; Servicio de Hematologia

Madrid, 28006, Spain

Location

Hospital Ramon y Cajal; Servicio de Hematologia

Madrid, 28034, Spain

Location

Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia

Murcia, 30120, Spain

Location

Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen del Rocio; Servicio de Hematologia

Seville, 41013, Spain

Location

Hospital Universitario la Fe; Servicio de Oncologia

Valencia, 46026, Spain

Location

National Cancer Inst.

Bangkok, 10400, Thailand

Location

Siriraj Hospital; Division of Hematology, Department of Medicine

Bangkok, 10700, Thailand

Location

Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

Khon Kaen, 40002, Thailand

Location

Adana Baskent University Hospital; Medical Oncology

Adana, 01120, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty; Hematology Department

Istanbul, 34098, Turkey (Türkiye)

Location

Bilim University School of Medicine; Hematology

Istanbul, 34394, Turkey (Türkiye)

Location

Dokuz Eylul Uni ; Hematology

Izmir, 35100, Turkey (Türkiye)

Location

Ege Uni Medical School; Hematology

Izmir, 35100, Turkey (Türkiye)

Location

Ninewells Hospital & Medical School; Ward 34

Dundee, DD1 9SY, United Kingdom

Location

Maidstone & Tonbridge Wells Hospital; Kent Oncology Center

Maidstone, ME16 9QQ, United Kingdom

Location

Derriford Hospital; Department of Haematology

Plymouth, PL6 8DH, United Kingdom

Location

Queen's Hospital; Oncology

Romford, RM7 0AG, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Pinderfields General Hospital; Dept of Haematology

Wakefield, WF1 4DG, United Kingdom

Location

New Cross Hospital; Dept. Of Haematology

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (4)

• Davies A, Merli F, Mihaljevic B, Mercadal S, Siritanaratkul N, Solal-Celigny P, Boehnke A, Berge C, Genevray M, Zharkov A, Dixon M, Brewster M, Barrett M, MacDonald D. Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial. Lancet Haematol. 2017 Jun;4(6):e272-e282. doi: 10.1016/S2352-3026(17)30078-9. Epub 2017 May 2.

  PMID: 28476440 DERIVED

• Davies A, Merli F, Mihaljevic B, Siritanaratkul N, Solal-Celigny P, Barrett M, Berge C, Bittner B, Boehnke A, McIntyre C, Macdonald D. Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study. Lancet Oncol. 2014 Mar;15(3):343-52. doi: 10.1016/S1470-2045(14)70005-1. Epub 2014 Feb 10.

  PMID: 24521993 DERIVED

• Mao CP, Brovarney MR, Dabbagh K, Birnbock HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013.

  PMID: 24265828 DERIVED

• Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013 Sep 17;109(6):1556-61. doi: 10.1038/bjc.2013.371. Epub 2013 Sep 3.

  PMID: 24002601 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Prednisolone

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

global-roche-genentech-trials@gene.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 14, 2010
• Study Start: February 15, 2011
• Primary Completion: June 12, 2012
• Study Completion: October 31, 2017
• Last Updated: November 27, 2018
• Results First Posted: August 5, 2015

Record last verified: 2018-10

Locations

ME (4); PE (3); RU (7); BE (3); BO (3); ES (11); FR (12); CA (6); GE (4); CO (4); GB (7); AU (5); SG (3); GR (2); IT (10); SE (2); SL (2); TH (3); ZA (5); NO (2); DE (20); TU (5); CR (2); BR (5); FI (1); NZ (2); RO (6); DK (6); MY (3); BU (4)