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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rituximab SC
Rituximab IV
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone/Prednisolone
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

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

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

Sites / Locations

  • Gosford Hospital; Cancer Care Services
  • Wollongong Hospital; Cancer Services
  • Royal Brisbane and Women's Hospital
  • Gold Coast Hospital; Haematology Department
  • Queen Elizabeth Hospital; Haematology
  • UZ Antwerpen
  • CHU Sart-Tilman
  • Sint Augustinus Wilrijk
  • University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept
  • University Clinical Center Sarajevo, Clinic for Hematology
  • University Clinical Centre Tuzla, Clinic for Oncology, Hematology and Radiotherapy
  • Nucleo de Hematologia e Transplante de Medula Ossea de Minas Gerais
  • Hospital das Clinicas - UFRGS
  • Hospital Sao Lucas - PUCRS
  • Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia
  • Hospital das Clinicas - FMUSP
  • UMHAT Dr Georgi Stranski; Hematology
  • Umhat S. George; Hematology
  • Specialised Hospital For Treatment Of Hematological Diseases; Hematology
  • Mhat Sveta Marina; Dept. of Haematology
  • Queen Elizabeth II Health Sciences Centre; Oncology
  • Cite de La Sante de Laval; Hemato-Oncologie
  • Centre de sante et de services sociaux Rimouski Neigette
  • Centre Hospitalier Universitaire de Sherbrooke
  • Centre hospitalier regional de Trois-Rivieres
  • CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie
  • Fundacion Cardioinfantil
  • Centro Medico Imbanaco
  • Hospital Pablo Tobon Uribe
  • Oncólogos de Occidente
  • UHC Rijeka
  • University Hospital Center Zagreb; Haematology Department
  • Herlev Uni Hospital; Hæmatologisk Afdeling L 121
  • Rigshospitalet; Hæmatologisk Klinik
  • Odense Universitetshospital; Hæmatologisk Afdeling
  • Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
  • Vejle Hospital; Dept of Medicine, Division of Hematology
  • Aarhus Universitetshospital, Hæmatologisk Afdeling R
  • Helsinki University Central Hospital; Dept of Oncology
  • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
  • Hopital Henri Mondor; Hematologie Clinique
  • Chu Site Du Bocage;Hematologie Clinique
  • Clinique Victor Hugo; Chimiotherapie
  • Institut J Paolii Calmettes; Onco Hematologie 1
  • Hopital Saint Eloi; Hematologie Oncologie Medicale
  • Hopital Hotel Dieu Et Hme;Hopital De Jour
  • Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
  • Hopital De Haut Leveque; Hematologie Clinique
  • Ch Lyon Sud; Hemato Secteur Jules Courmont
  • Hopital De La Miletrie; Hematologie Et Oncologie Medicale
  • Hopital Bretonneau; Hematologie Therapie Cellulaire
  • M.Zodelava's Hematology Center
  • Mediclub
  • Institute of Hematology and Transfusiology
  • Chemotherapy and Immunotherapy Clinic Medulla
  • Onkologische Schwerpunktpraxis Kurfürstendamm
  • Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie
  • Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin
  • PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann
  • Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I
  • Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
  • Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.
  • Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
  • St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2
  • UKSH Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie
  • Gemeinschaftspraxis PD Dr. med. Marcel Reiser und Dr. med. Ildiko Kátay
  • Onkologische Gemeinschaftspraxis
  • Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
  • Medizinisches Versorgungszentrum MOP
  • Praxis Dr.med. Jens Uhlig
  • Praxis Dr. Clemens Müller-Naendrup (Onkologische Schwerpunktpraxis im MVZ 2 GmbH)
  • Prosper-Hospital, Medizinische Klinik I
  • Praxis Dr. Fenchel
  • Caritas Kilinik St. Theresia; Abt. Innere Medizin
  • Praxis für Hämatologie & Onkologie
  • Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
  • Attiko Hospital; Haematology Clinic
  • Azienda Ospedaliera Ospedale S.Carlo; Ematologia
  • A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
  • AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
  • Ospedale S. Eugenio; Divisione Di Ematologia
  • Uni Degli Studi Di Genova; 1A Divisione Di Ematologia
  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
  • Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia
  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
  • Ospedale Ca Foncello; Ematologia
  • Ospedale Di Vicenza; Nefrologia, Ematologia
  • University Clinic for Hematology; HSCT Department
  • University Clinic of Hematology Skopje, Hospital Care Department
  • University Malaya Medical Center; Hematology Unit of Department of Internal Medicine
  • Ampang Hospital; Department of Haematology
  • Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
  • Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
  • Hospital General De Culiacan; Servicio De Hematologia
  • Hospital Universitario Dr. Jose E. Gonzalez; Haematology
  • Centro de Estudios Clinicos de Queretaro (CECLIQ)
  • Canterbury Health Laboratories; Haematology
  • Palmerston North Hospital; Regional Cancer Treatment Service
  • Instituto;Oncologico Miraflores
  • Oncosalud Sac; Oncología
  • Hospital Maria Auxiliadora
  • Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie
  • Fundeni Clinical Inst. ; Hematology Dept
  • Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie
  • Institutul Regional de Oncologie Iasi; Clinica de Hematologie
  • Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
  • Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan
  • N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
  • Haematology Research Center; Haematology
  • Penza Regional Oncology Dispensary
  • St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
  • Research Inst. of Hematology & Blood Transfusion ; Hematology
  • Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology
  • Institute of Hematology
  • Clinical Center Vojvodine; Clinic for Hematology
  • National University Hospital; National University Cancer Institute, Singapore (NCIS)
  • Singapore General Hospital; Department of Haematology
  • National Cancer Centre; Medical Oncology
  • St. Elisabeths Cancer Center
  • National Cancer Inst. ; Dept. of Chemotherapy
  • National Hospital; Oncotherapy Dept
  • King Edward VIII; Department of Haematology
  • Durban Oncology Center
  • University of Witwatersrand/Johannesburg Hospital; Dept. of ocnology
  • Cancercare
  • Hospital Universitario Puerta del Mar; Servicio de Hematologia
  • Hospital del Mar; Servicio de Hematologia
  • Hospital Universitari Vall d'Hebron; Servicio de Hematologia
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Hospital Duran i Reynals; Servicio de Hematologia
  • Hospital Universitario de la Princesa; Servicio de Hematologia
  • Hospital Ramon y Cajal; Servicio de Hematologia
  • Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia
  • Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
  • Hospital Universitario Virgen del Rocio; Servicio de Hematologia
  • Hospital Universitario la Fe; Servicio de Oncologia
  • National Cancer Inst.
  • Siriraj Hospital; Division of Hematology, Department of Medicine
  • Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
  • Adana Baskent University Hospital; Medical Oncology
  • Istanbul University Cerrahpasa Medical Faculty; Hematology Department
  • Bilim University School of Medicine; Hematology
  • Dokuz Eylul Uni ; Hematology
  • Ege Uni Medical School; Hematology
  • Ninewells Hospital & Medical School; Ward 34
  • Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
  • Derriford Hospital; Department of Haematology
  • Queen's Hospital; Oncology
  • Southampton General Hospital
  • Pinderfields General Hospital; Dept of Haematology
  • New Cross Hospital; Dept. Of Haematology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

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

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Overall Response comprised CR, 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 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 >75% in the SPD; PR: ≥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 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
Overall Response comprised of CR, 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 CT scans. Assessment of tumour 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 >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Complete Response was comprised CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and 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 >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and 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 >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
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
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and 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 >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
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
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and 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 >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
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
Overall Response comprised of CR, 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 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 >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death
Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years])
Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL
PFS was defined as the time from randomization to disease progression/relapse or death due to any cause. If the specified event (disease progression/relapse, death) did not occur, PFS was censored at the last tumor assessment date showing no disease progression, either during treatment or follow-up. Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. PFS analysis was performed using Kaplan - Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years])
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
Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years])
Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL
Event-free survival was defined as the time from randomization to disease progression/relapse, death or initiation of new NHL therapy. If the specified event (progression/relapse, death or new anti-lymphoma treatment) did not occur, event-free survival was censored at the last tumor assessment date either during treatment or follow up. Event-free survival analysis was performed using Kaplan-Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years])
Percentage of Participants Who Died
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants without event were censored at the time of last follow-up information for survival, ie, at the last time known to be alive.
Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Predose (within 2 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy 7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months])
Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab
Predose (within 2 hr) and 24 hrs postdose on Cy7 (D1,3,7,15), predose (0 hr) on Cy8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months])
Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle
Stage I and II (Induction): Rituximab IV: Predose (within 2 hr) on D1 of Cy1-8 (1 Cy=3 weeks & 4 weeks for Cy8); Rituximab SC: Predose (within 2 hr) on D1 of Cy1 & Cy3-8 (1 Cy=3 weeks and 4 weeks for Cy8), predose (within 2 hr) on D0 of Cy2 (up to data cutoff of 31 Oct 2013 [up to 32 months])
Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle
Stage I and II (maintenance): D29 of Cy8 (induction; 1 Cy=4 weeks), predose (within 2 hr) on D1 of Cy9 to 19 (maintenance Cy1 to 12 [1 Cy=8 weeks]; up to data cutoff of 11 Jan 2016 [up to 6 years])
Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration
Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase
Depletion is defined as a cluster of differentiation (CD) 19 value <80 cells per cubic millimeter (cells/mm^3).
Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase
Depletion is defined as a CD19 value <80 cells/mm^3.
Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Levels of HACA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])
Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab
Levels of HAHA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])
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
All investigator physicians and nurses involved in this study were asked to provide the staff time that could be saved with each administration of rituximab SC as compared with rituximab IV to participants in routine practice afetr Cy 8, 15, 20 and categorized as less than (<) 1 hr, at least 1 hr but <2 hrs, at least 2 hrs but <3 hrs, at least 3 hrs but <4 hrs, >/=4 hrs. Staff were asked not to consider the time needed for the first IV administration. Analysis was done in all participants to show a comparison on the time saved by staffs when administered via SC and IV.
Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion
All investigator physicians and nurses involved in this study were asked to complete question i.e. "Which formulation of rituximab (SC or IV) do you think is more convenient?" based on their experience with the rituximab SC and IV formulations across all participants and presented as rituximab SC is much more convenient; rituximab SC is a little more convenient; both formulations are equally convenient; rituximab IV is a little more convenient; and rituximab IV is much more convenient.

Full Information

First Posted
September 10, 2010
Last Updated
October 29, 2018
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01200758
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 15, 2011 (Actual)
Primary Completion Date
June 12, 2012 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab SC
Other Intervention Name(s)
MabThera
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab IV
Other Intervention Name(s)
MabThera
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Eight cycles of cyclophosphamide (750 mg/m^2 IV) administered every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Eight cycles of doxorubicin (50 mg/m^2 IV) administered every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Eight cycles of doxorubicin (1.4 mg/m^2 IV) administered every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Prednisone/Prednisolone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab
Time Frame
Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)
Title
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)
Description
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.
Time Frame
Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Secondary Outcome Measure Information:
Title
Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Description
Overall Response comprised CR, 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 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 >75% in the SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.
Time Frame
Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Title
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
Description
Overall Response comprised of CR, 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 CT scans. Assessment of tumour 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 >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Time Frame
Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Title
Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Description
Complete Response was comprised CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and 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 >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Time Frame
Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Title
Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Description
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and 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 >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Time Frame
Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Title
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
Description
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and 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 >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Time Frame
Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Title
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
Description
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and 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 >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Time Frame
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)
Title
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
Description
Overall Response comprised of CR, 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 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 >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Time Frame
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)
Title
Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death
Description
Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years])
Time Frame
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)
Title
Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL
Description
PFS was defined as the time from randomization to disease progression/relapse or death due to any cause. If the specified event (disease progression/relapse, death) did not occur, PFS was censored at the last tumor assessment date showing no disease progression, either during treatment or follow-up. Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. PFS analysis was performed using Kaplan - Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years])
Time Frame
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)
Title
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
Description
Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years])
Time Frame
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)
Title
Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL
Description
Event-free survival was defined as the time from randomization to disease progression/relapse, death or initiation of new NHL therapy. If the specified event (progression/relapse, death or new anti-lymphoma treatment) did not occur, event-free survival was censored at the last tumor assessment date either during treatment or follow up. Event-free survival analysis was performed using Kaplan-Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years])
Time Frame
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)
Title
Percentage of Participants Who Died
Time Frame
Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])
Title
Overall Survival (OS)
Description
OS was defined as the time from randomization to death due to any cause. Participants without event were censored at the time of last follow-up information for survival, ie, at the last time known to be alive.
Time Frame
Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])
Title
Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab
Description
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Predose (within 2 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy 7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months])
Time Frame
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)
Title
Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab
Description
Predose (within 2 hr) and 24 hrs postdose on Cy7 (D1,3,7,15), predose (0 hr) on Cy8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months])
Time Frame
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)
Title
Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle
Description
Stage I and II (Induction): Rituximab IV: Predose (within 2 hr) on D1 of Cy1-8 (1 Cy=3 weeks & 4 weeks for Cy8); Rituximab SC: Predose (within 2 hr) on D1 of Cy1 & Cy3-8 (1 Cy=3 weeks and 4 weeks for Cy8), predose (within 2 hr) on D0 of Cy2 (up to data cutoff of 31 Oct 2013 [up to 32 months])
Time Frame
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)
Title
Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle
Description
Stage I and II (maintenance): D29 of Cy8 (induction; 1 Cy=4 weeks), predose (within 2 hr) on D1 of Cy9 to 19 (maintenance Cy1 to 12 [1 Cy=8 weeks]; up to data cutoff of 11 Jan 2016 [up to 6 years])
Time Frame
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)
Title
Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration
Time Frame
12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years])
Title
Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase
Description
Depletion is defined as a cluster of differentiation (CD) 19 value <80 cells per cubic millimeter (cells/mm^3).
Time Frame
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
Title
Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase
Description
Depletion is defined as a CD19 value <80 cells/mm^3.
Time Frame
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])
Title
Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Description
Levels of HACA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])
Time Frame
Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)
Title
Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab
Description
Levels of HAHA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])
Time Frame
Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)
Title
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
Description
All investigator physicians and nurses involved in this study were asked to provide the staff time that could be saved with each administration of rituximab SC as compared with rituximab IV to participants in routine practice afetr Cy 8, 15, 20 and categorized as less than (<) 1 hr, at least 1 hr but <2 hrs, at least 2 hrs but <3 hrs, at least 3 hrs but <4 hrs, >/=4 hrs. Staff were asked not to consider the time needed for the first IV administration. Analysis was done in all participants to show a comparison on the time saved by staffs when administered via SC and IV.
Time Frame
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)
Title
Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion
Description
All investigator physicians and nurses involved in this study were asked to complete question i.e. "Which formulation of rituximab (SC or IV) do you think is more convenient?" based on their experience with the rituximab SC and IV formulations across all participants and presented as rituximab SC is much more convenient; rituximab SC is a little more convenient; both formulations are equally convenient; rituximab IV is a little more convenient; and rituximab IV is much more convenient.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Gosford Hospital; Cancer Care Services
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Wollongong Hospital; Cancer Services
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Gold Coast Hospital; Haematology Department
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Queen Elizabeth Hospital; Haematology
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Sint Augustinus Wilrijk
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept
City
Banja Luka
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Sarajevo, Clinic for Hematology
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Centre Tuzla, Clinic for Oncology, Hematology and Radiotherapy
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
Nucleo de Hematologia e Transplante de Medula Ossea de Minas Gerais
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30140-001
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Hospital das Clinicas - FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
UMHAT Dr Georgi Stranski; Hematology
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Umhat S. George; Hematology
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Specialised Hospital For Treatment Of Hematological Diseases; Hematology
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Mhat Sveta Marina; Dept. of Haematology
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Queen Elizabeth II Health Sciences Centre; Oncology
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Cite de La Sante de Laval; Hemato-Oncologie
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
Centre de sante et de services sociaux Rimouski Neigette
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Centre hospitalier regional de Trois-Rivieres
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Fundacion Cardioinfantil
City
Bogota
Country
Colombia
Facility Name
Centro Medico Imbanaco
City
Cali
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin-Antioquia
Country
Colombia
Facility Name
Oncólogos de Occidente
City
Pereira
ZIP/Postal Code
600004
Country
Colombia
Facility Name
UHC Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
University Hospital Center Zagreb; Haematology Department
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Herlev Uni Hospital; Hæmatologisk Afdeling L 121
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Rigshospitalet; Hæmatologisk Klinik
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense Universitetshospital; Hæmatologisk Afdeling
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Vejle Hospital; Dept of Medicine, Division of Hematology
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Aarhus Universitetshospital, Hæmatologisk Afdeling R
City
Århus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Helsinki University Central Hospital; Dept of Oncology
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Facility Name
Hopital Henri Mondor; Hematologie Clinique
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Chu Site Du Bocage;Hematologie Clinique
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Clinique Victor Hugo; Chimiotherapie
City
Le Mans
ZIP/Postal Code
72015
Country
France
Facility Name
Institut J Paolii Calmettes; Onco Hematologie 1
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Hopital Saint Eloi; Hematologie Oncologie Medicale
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Hotel Dieu Et Hme;Hopital De Jour
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital De Haut Leveque; Hematologie Clinique
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Ch Lyon Sud; Hemato Secteur Jules Courmont
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Hopital De La Miletrie; Hematologie Et Oncologie Medicale
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Hopital Bretonneau; Hematologie Therapie Cellulaire
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
M.Zodelava's Hematology Center
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Mediclub
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Institute of Hematology and Transfusiology
City
Tbilisi
ZIP/Postal Code
0177
Country
Georgia
Facility Name
Chemotherapy and Immunotherapy Clinic Medulla
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Onkologische Schwerpunktpraxis Kurfürstendamm
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Facility Name
Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann
City
Frechen
ZIP/Postal Code
50226
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.
City
Halle
ZIP/Postal Code
06110
Country
Germany
Facility Name
Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Facility Name
UKSH Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Gemeinschaftspraxis PD Dr. med. Marcel Reiser und Dr. med. Ildiko Kátay
City
Koeln
ZIP/Postal Code
50674
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Medizinisches Versorgungszentrum MOP
City
München
ZIP/Postal Code
80335
Country
Germany
Facility Name
Praxis Dr.med. Jens Uhlig
City
Naunhof
ZIP/Postal Code
04683
Country
Germany
Facility Name
Praxis Dr. Clemens Müller-Naendrup (Onkologische Schwerpunktpraxis im MVZ 2 GmbH)
City
Olpe
ZIP/Postal Code
57462
Country
Germany
Facility Name
Prosper-Hospital, Medizinische Klinik I
City
Recklinghausen
ZIP/Postal Code
45659
Country
Germany
Facility Name
Praxis Dr. Fenchel
City
Saalfeld
ZIP/Postal Code
07318
Country
Germany
Facility Name
Caritas Kilinik St. Theresia; Abt. Innere Medizin
City
Saarbruecken
ZIP/Postal Code
66113
Country
Germany
Facility Name
Praxis für Hämatologie & Onkologie
City
Saarbruecken
ZIP/Postal Code
66113
Country
Germany
Facility Name
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Attiko Hospital; Haematology Clinic
City
Athens
ZIP/Postal Code
124 62
Country
Greece
Facility Name
Azienda Ospedaliera Ospedale S.Carlo; Ematologia
City
Potenza
State/Province
Basilicata
ZIP/Postal Code
85100
Country
Italy
Facility Name
A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
Facility Name
Ospedale S. Eugenio; Divisione Di Ematologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Facility Name
Uni Degli Studi Di Genova; 1A Divisione Di Ematologia
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Ospedale Ca Foncello; Ematologia
City
Treviso
State/Province
Veneto
ZIP/Postal Code
31100
Country
Italy
Facility Name
Ospedale Di Vicenza; Nefrologia, Ematologia
City
Vicenza
State/Province
Veneto
ZIP/Postal Code
36100
Country
Italy
Facility Name
University Clinic for Hematology; HSCT Department
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
University Clinic of Hematology Skopje, Hospital Care Department
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
University Malaya Medical Center; Hematology Unit of Department of Internal Medicine
City
Kuala Lumpur
State/Province
FED. Territory OF Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Ampang Hospital; Department of Haematology
City
Ampang
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
City
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Hospital General De Culiacan; Servicio De Hematologia
City
Culiacan
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose E. Gonzalez; Haematology
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Centro de Estudios Clinicos de Queretaro (CECLIQ)
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Canterbury Health Laboratories; Haematology
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Palmerston North Hospital; Regional Cancer Treatment Service
City
Palmerston North
ZIP/Postal Code
4442
Country
New Zealand
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
Hospital Maria Auxiliadora
City
Lima
ZIP/Postal Code
Lima 29
Country
Peru
Facility Name
Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie
City
Brasov
ZIP/Postal Code
500326
Country
Romania
Facility Name
Fundeni Clinical Inst. ; Hematology Dept
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie
City
Iasi
ZIP/Postal Code
700111
Country
Romania
Facility Name
Institutul Regional de Oncologie Iasi; Clinica de Hematologie
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
City
Targu-mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
City
Timisoara
ZIP/Postal Code
300079
Country
Romania
Facility Name
Clinical Oncology Dispensary of Ministry of Health 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
Haematology Research Center; Haematology
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Penza Regional Oncology Dispensary
City
Penza
ZIP/Postal Code
440071
Country
Russian Federation
Facility Name
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Inst. of Hematology & Blood Transfusion ; Hematology
City
St Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology
City
St.Petersburg, Pesochny
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Institute of Hematology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Vojvodine; Clinic for Hematology
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
National University Hospital; National University Cancer Institute, Singapore (NCIS)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Singapore General Hospital; Department of Haematology
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
St. Elisabeths Cancer Center
City
Bratislava
ZIP/Postal Code
812 50
Country
Slovakia
Facility Name
National Cancer Inst. ; Dept. of Chemotherapy
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
National Hospital; Oncotherapy Dept
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
King Edward VIII; Department of Haematology
City
Congella
ZIP/Postal Code
4013
Country
South Africa
Facility Name
Durban Oncology Center
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
University of Witwatersrand/Johannesburg Hospital; Dept. of ocnology
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Cancercare
City
Kraaifontein
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Hospital Universitario Puerta del Mar; Servicio de Hematologia
City
Cádiz
State/Province
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital del Mar; Servicio de Hematologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Duran i Reynals; Servicio de Hematologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario de la Princesa; Servicio de Hematologia
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Hematologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Hematologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Oncologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
National Cancer Inst.
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
Adana Baskent University Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty; Hematology Department
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Bilim University School of Medicine; Hematology
City
Istanbul
ZIP/Postal Code
34394
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
Ninewells Hospital & Medical School; Ward 34
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Derriford Hospital; Department of Haematology
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Queen's Hospital; Oncology
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Pinderfields General Hospital; Dept of Haematology
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Facility Name
New Cross Hospital; Dept. Of Haematology
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28476440
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.
Results Reference
derived
PubMed Identifier
24521993
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.
Results Reference
derived
PubMed Identifier
24265828
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.
Results Reference
derived
PubMed Identifier
24002601
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.
Results Reference
derived

Learn more about this trial

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

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