Clinical trial NCT01200758: A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma
Official title: A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-09-14
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab
timeFrame: Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)
measure: 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)
timeFrame: Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Secondary outcomes:
measure: Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
timeFrame: Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
measure: 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
timeFrame: Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
measure: Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
timeFrame: Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
measure: Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
timeFrame: Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
measure: 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
timeFrame: Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
measure: Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL
timeFrame: Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)
measure: Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL
timeFrame: Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)
measure: Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death
timeFrame: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
measure: Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL
timeFrame: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
measure: Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse, New Anti-Lymphoma Treatment or Death Assessed Using International Working Group Response Criteria for NHL
timeFrame: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
measure: Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL
timeFrame: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
measure: Percentage of Participants Who Died
timeFrame: Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])
measure: Overall Survival (OS)
timeFrame: Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])
measure: Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab
timeFrame: Stage I (Induction): Predose (within 2 hour [hr]) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)
measure: Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab
timeFrame: Stage I (Induction): Predose (within 2hr) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)
measure: Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle
timeFrame: Stage I and II (Pooled): Predose (within 2hr) up to data cutoff of 31 Oct 2013 [up to 32 months]) (See detailed timeframe in Outcome Measure description)
measure: Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle
timeFrame: Stage I and II (maintenance): Predose (within 2hr) up to data cutoff of 11 Jan 2016 [up to 6 years]) (See detailed timeframe in Outcome Measure description)
measure: Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration
timeFrame: 12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years])
measure: Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase
timeFrame: Stage I and II (induction): for rituximab IV - D1 of Cy 1 to 8 (1 Cy=3 weeks); for rituximab SC - D1 of Cy 1 and Cy 3 to 8, D0 of Cy 2
measure: Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase
timeFrame: Stage I and II (maintenance): D1 of Cy 9 to 20 (1 Cy=8 weeks) (up to data cutoff of 11 Jan 2016 [up to 6 years])
measure: Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab
timeFrame: Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)
measure: Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab
timeFrame: Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)
measure: Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20
timeFrame: After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)
measure: Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion
timeFrame: After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)
Other outcomes:
Locations:
city: Gosford
country: Australia
facility: Gosford Hospital; Cancer Care Services
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital; Cancer Services
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Southport
country: Australia
facility: Gold Coast Hospital; Haematology Department
state: Queensland
city: Woodville South
country: Australia
facility: Queen Elizabeth Hospital; Haematology
state: South Australia
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept
city: Sarajevo
country: Bosnia and Herzegovina
facility: University Clinical Center Sarajevo, Clinic for Hematology
city: Tuzla
country: Bosnia and Herzegovina
facility: University Clinical Centre Tuzla, Clinic for Oncology, Hematology and Radiotherapy
city: Belo Horizonte
country: Brazil
facility: Nucleo de Hematologia e Transplante de Medula Ossea de Minas Gerais
state: MG
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Sao Paulo
country: Brazil
facility: Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP
state: SP
city: Pleven
country: Bulgaria
facility: UMHAT Dr Georgi Stranski; Hematology
city: Plovdiv
country: Bulgaria
facility: Umhat S. George; Hematology
city: Sofia
country: Bulgaria
facility: Specialised Hospital For Treatment Of Hematological Diseases; Hematology
city: Varna
country: Bulgaria
facility: Mhat Sveta Marina; Dept. of Haematology
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre; Oncology
state: Nova Scotia
city: Laval
country: Canada
facility: Cite de La Sante de Laval; Hemato-Oncologie
state: Quebec
city: Rimouski
country: Canada
facility: Centre de sante et de services sociaux Rimouski Neigette
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Centre hospitalier regional de Trois-Rivieres
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie
city: Bogota
country: Colombia
facility: Fundacion Cardioinfantil
city: Cali
country: Colombia
facility: Centro Medico Imbanaco
city: Medellin-Antioquia
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Pereira
country: Colombia
facility: Oncólogos de Occidente
city: Rijeka
country: Croatia
facility: UHC Rijeka
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb; Haematology Department
city: Herlev
country: Denmark
facility: Herlev Uni Hospital; Hæmatologisk Afdeling L 121
city: København Ø
country: Denmark
facility: Rigshospitalet; Hæmatologisk Klinik
city: Odense C
country: Denmark
facility: Odense Universitetshospital; Hæmatologisk Afdeling
city: Roskilde
country: Denmark
facility: Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
city: Vejle
country: Denmark
facility: Vejle Hospital; Dept of Medicine, Division of Hematology
city: Århus
country: Denmark
facility: Aarhus Universitetshospital, Hæmatologisk Afdeling R
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital; Dept of Oncology
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
city: Creteil
country: France
facility: Hopital Henri Mondor; Hematologie Clinique
city: Dijon
country: France
facility: Chu Site Du Bocage;Hematologie Clinique
city: Le Mans
country: France
facility: Clinique Victor Hugo; Chimiotherapie
city: Marseille
country: France
facility: Institut J Paolii Calmettes; Onco Hematologie 1
city: Montpellier
country: France
facility: Hopital Saint Eloi; Hematologie Oncologie Medicale
city: Nantes
country: France
facility: Hopital Hotel Dieu Et Hme;Hopital De Jour
city: Paris
country: France
facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
city: Pessac
country: France
facility: Hopital De Haut Leveque; Hematologie Clinique
city: Pierre Benite
country: France
facility: Ch Lyon Sud; Hemato Secteur Jules Courmont
city: Poitiers
country: France
facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale
city: Tours
country: France
facility: Hopital Bretonneau; Hematologie Therapie Cellulaire
city: Tbilisi
country: Georgia
facility: M.Zodelava's Hematology Center
city: Tbilisi
country: Georgia
facility: Mediclub
city: Tbilisi
country: Georgia
facility: Institute of Hematology and Transfusiology
city: Tbilisi
country: Georgia
facility: Chemotherapy and Immunotherapy Clinic Medulla
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfürstendamm
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin
city: Frechen
country: Germany
facility: PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann
city: Giessen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
city: Halle
country: Germany
facility: Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.
city: Hannover
country: Germany
facility: Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
city: Karlsruhe
country: Germany
facility: St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2
city: Kiel
country: Germany
facility: UKSH Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie
city: Koeln
country: Germany
facility: Gemeinschaftspraxis PD Dr. med. Marcel Reiser und Dr. med. Ildiko Kátay
city: Magdeburg
country: Germany
facility: Onkologische Gemeinschaftspraxis
city: Marburg
country: Germany
facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
city: München
country: Germany
facility: Medizinisches Versorgungszentrum MOP
city: Naunhof
country: Germany
facility: Praxis Dr.med. Jens Uhlig
city: Olpe
country: Germany
facility: Praxis Dr. Clemens Müller-Naendrup (Onkologische Schwerpunktpraxis im MVZ 2 GmbH)
city: Recklinghausen
country: Germany
facility: Prosper-Hospital, Medizinische Klinik I
city: Saalfeld
country: Germany
facility: Praxis Dr. Fenchel
city: Saarbruecken
country: Germany
facility: Caritas Kilinik St. Theresia; Abt. Innere Medizin
city: Saarbruecken
country: Germany
facility: Praxis für Hämatologie & Onkologie
city: Athens
country: Greece
facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
city: Athens
country: Greece
facility: Attiko Hospital; Haematology Clinic
city: Potenza
country: Italy
facility: Azienda Ospedaliera Ospedale S.Carlo; Ematologia
state: Basilicata
city: Napoli
country: Italy
facility: A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
state: Campania
city: Reggio Emilia
country: Italy
facility: AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
state: Emilia-Romagna
city: Roma
country: Italy
facility: Ospedale S. Eugenio; Divisione Di Ematologia
state: Lazio
city: Genova
country: Italy
facility: Uni Degli Studi Di Genova; 1A Divisione Di Ematologia
state: Liguria
city: Brescia
country: Italy
facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia
state: Lombardia
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
state: Puglia
city: Treviso
country: Italy
facility: Ospedale Ca Foncello; Ematologia
state: Veneto
city: Vicenza
country: Italy
facility: Ospedale Di Vicenza; Nefrologia, Ematologia
state: Veneto
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: University Clinic for Hematology; HSCT Department
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: University Clinic of Hematology Skopje, Hospital Care Department
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center; Hematology Unit of Department of Internal Medicine
state: FED. Territory OF Kuala Lumpur
city: Ampang
country: Malaysia
facility: Ampang Hospital; Department of Haematology
city: Sarawak
country: Malaysia
facility: Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
city: Chihuahua
country: Mexico
facility: Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
city: Culiacan
country: Mexico
facility: Hospital General De Culiacan; Servicio De Hematologia
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology
city: Queretaro
country: Mexico
facility: Centro de Estudios Clinicos de Queretaro (CECLIQ)
city: Christchurch
country: New Zealand
facility: Canterbury Health Laboratories; Haematology
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital; Regional Cancer Treatment Service
city: Lima
country: Peru
facility: Instituto;Oncologico Miraflores
city: Lima
country: Peru
facility: Oncosalud Sac; Oncología
city: Lima
country: Peru
facility: Hospital Maria Auxiliadora
city: Brasov
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie
city: Bucharest
country: Romania
facility: Fundeni Clinical Inst. ; Hematology Dept
city: Iasi
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie
city: Targu-mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
city: Timisoara
country: Romania
facility: Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
city: Kazan
country: Russian Federation
facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan
city: Moscow
country: Russian Federation
facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
city: Moscow
country: Russian Federation
facility: Haematology Research Center; Haematology
city: Penza
country: Russian Federation
facility: Penza Regional Oncology Dispensary
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
city: St Petersburg
country: Russian Federation
facility: Research Inst. of Hematology & Blood Transfusion ; Hematology
city: St.Petersburg, Pesochny
country: Russian Federation
facility: Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology
city: Belgrade
country: Serbia
facility: Institute of Hematology
city: Novi Sad
country: Serbia
facility: Clinical Center Vojvodine; Clinic for Hematology
city: Singapore
country: Singapore
facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)
city: Singapore
country: Singapore
facility: Singapore General Hospital; Department of Haematology
city: Singapore
country: Singapore
facility: National Cancer Centre; Medical Oncology
city: Bratislava
country: Slovakia
facility: St. Elisabeths Cancer Center
city: Bratislava
country: Slovakia
facility: National Cancer Inst. ; Dept. of Chemotherapy
city: Bloemfontein
country: South Africa
facility: National Hospital; Oncotherapy Dept
city: Congella
country: South Africa
facility: King Edward VIII; Department of Haematology
city: Durban
country: South Africa
facility: Durban Oncology Center
city: Johannesburg
country: South Africa
facility: University of Witwatersrand/Johannesburg Hospital; Dept. of ocnology
city: Kraaifontein
country: South Africa
facility: Cancercare
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar; Servicio de Hematologia
state: Cadiz
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Hematologia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals; Servicio de Hematologia
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa; Servicio de Hematologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Hematologia
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Oncologia
city: Bangkok
country: Thailand
facility: National Cancer Inst.
city: Bangkok
country: Thailand
facility: Siriraj Hospital; Division of Hematology, Department of Medicine
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
city: Adana
country: Turkey
facility: Adana Baskent University Hospital; Medical Oncology
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty; Hematology Department
city: Istanbul
country: Turkey
facility: Bilim University School of Medicine; Hematology
city: Izmir
country: Turkey
facility: Dokuz Eylul Uni ; Hematology
city: Izmir
country: Turkey
facility: Ege Uni Medical School; Hematology
city: Dundee
country: United Kingdom
facility: Ninewells Hospital & Medical School; Ward 34
city: Maidstone
country: United Kingdom
facility: Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
city: Plymouth
country: United Kingdom
facility: Derriford Hospital; Department of Haematology
city: Romford
country: United Kingdom
facility: Queen's Hospital; Oncology
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Wakefield
country: United Kingdom
facility: Pinderfields General Hospital; Dept of Haematology
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital; Dept. Of Haematology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.