A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)
A Single Arm, Multicentre, Phase IIIB Study to Evaluate Safety, Efficacy and Pharmacokinetic (PK) of Subcutaneous (SC) Rituximab Administered During Induction Phase or Maintenance in Previously Untreated Patients With CD20+ Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)
2 other identifiers
interventional
159
1 country
39
Brief Summary
This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic (PK) of subcutaneous (SC) rituximab in previously untreated participants with cluster of differentiation 20 positive (CD20+) DLBCL or FL. In addition to standard chemotherapy, participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 lymphoma
Started Jul 2013
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2013
CompletedFirst Posted
Study publicly available on registry
June 28, 2013
CompletedStudy Start
First participant enrolled
July 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2019
CompletedResults Posted
Study results publicly available
August 13, 2020
CompletedAugust 13, 2020
July 1, 2020
5.8 years
June 26, 2013
May 28, 2020
July 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Administration-Associated Reactions (AAR)
AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Baseline up to 54 months
Secondary Outcomes (20)
Percentage of Participants With At Least One Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs)
Baseline up to 54 months
Percentage of Participants With At Least One Grade ≥ 3 Infusion/ Injection Related Reactions (IIRRs)
Baseline up to 54 months
Percentage of Participants With At Least One Treatment-Emergent Serious Adverse Events
Baseline up to 54 months
Percentage of Participants With Event-Free Survival (EFS) According to IWG Response Criteria
Day 1 up to first occurrence of progression or relapse, or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first (up to maximum 54 months)
Percentage of Participants With Progression-Free Survival (PFS) According to IWG Response Criteria
Day 1 up to first occurrence of progression or relapse, or death, whichever occurs first (up to maximum 54 months)
- +15 more secondary outcomes
Study Arms (1)
Rituximab
EXPERIMENTALParticipants will receive at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period, in addition to standard chemotherapy. Standard chemotherapy regimen included cyclophosphamide, vincristine, doxorubicin and prednisone (CHOP); or cyclophosphamide, vincristine and prednisone (CVP); or bendamustine as per standard local practice.
Interventions
Rituximab will be administered at a dose of 1400 mg SC once a month for at least 4 doses during the Induction period, and at a dose of 1400 mg SC once every two months for at least 6 doses during the Maintenance period.
Cyclophosphamide will be administered as per standard local practice as a part of standard chemotherapy regimen.
Vincristine will be administered as per standard local practice as a part of standard chemotherapy regimen.
Doxorubicin will be administered as per standard local practice as a part of standard chemotherapy regimen.
Prednisone will be administered as per standard local practice as a part of standard chemotherapy regimen.
Bendamustine will be administered as per standard local practice as a part of standard chemotherapy regimen.
Eligibility Criteria
You may qualify if:
- Histologically confirmed, CD20+ DLBCL or CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2 or 3a, according to the World Health Organization (WHO) classification system
- Currently being treated with rituximab intravenously (IV) in the Induction or Maintenance period, having received at least one full dose of rituximab IV, defined as standard full dose of rituximab IV 375 milligrams per square-meter (mg/m\^2) administered without interruption or early discontinuation (i.e. tolerability issues)
- Expectation and current ability for the participant to receive at least 4 additional cycles of treatment during the Induction period or 6 additional cycles of treatment during the Maintenance period (participants with follicular NHL)
- An International Prognostic Index (IPI) score of 1-4 or IPI score of 0 with bulky disease, defined as one lesion greater than or equal to (\>=) 7.5 centimeters (cm), or Follicular Lymphoma International Prognostic Index (FLIPI) (low, intermediate or high risk) assessed before the first rituximab IV administration in Induction period
- At least one bi-dimensionally measurable lesion defined as \>=1.5 cm in its largest dimension on computed tomography (CT) scan
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 3
You may not qualify if:
- Transformed lymphoma or FL IIIB
- Primary central nervous system lymphoma, histologic evidence of transformation to a Burkitt lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, or primary cutaneous DLBCL
- History of other malignancy
- Ongoing corticosteroid use greater than (\>) 30 milligrams per day (mg/day) of prednisone or equivalent
- Inadequate renal, hematologic, or hepatic function
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- Contraindications to any of the individual components of standard chemotherapy
- Other serious underlying medical conditions, which, in the Investigator's judgement, could impair the ability of the participant to participate in the study
- Recent major surgery (within 4 weeks prior to dosing, other than for diagnosis)
- Active hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, or human immunodeficiency virus (HIV) infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Apulia, 70124, Italy
Azienda ospedaliera oo rr di foggi; Hematology
Foggia, Apulia, 71100, Italy
Irccs Crob
Rionero in Vulture, Basilicate, 85028, Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli; Unità Operativa di Ematologia
Reggio Calabria, Calabria, 89100, Italy
Azienda Ospedaliera S.G. Moscati; Divisione Ematologia
Avellino, Campania, 83100, Italy
Asl ce - p.o. Avers; Uoc ematologia
Aversa, Campania, 81031, Italy
A.O. San Sebastiano; U.O.C. Oncologia
Caserta, Campania, 81100, Italy
Seconda università degli studi di napoli; Medicina clinica e sperimentale magrassi - lanzara
Napoli, Campania, 80138, Italy
Osp. Santa Maria Goretti; Ematologia
Latina, Lazio, 04100, Italy
Ospedale S. Eugenio; Divisione Di Ematologia
Rome, Lazio, 00144, Italy
Regina Elena National Cancer Institute; Hematology
Rome, Lazio, 00144, Italy
Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo
Rome, Lazio, 00152, Italy
Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
Rome, Lazio, 00161, Italy
Azienda Ospedaliera S. Giovanni Addolorata; UOC Ematologia
Rome, Lazio, 00184, Italy
ASL Viterbo; Presidio Ospedaliero di Ronciglione; UOC Ematologia
Ronciglione, Lazio, 01037, Italy
Ospedale Valduce;U.O.S. Oncologia Ed Ematologia
Como, Lombardy, 22100, Italy
ASST DI CREMA; U O Oncologia Medica
Crema, Lombardy, 26013, Italy
ASST DI LECCO; Oncologia Medica
Lecco, Lombardy, 23900, Italy
Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
Mantova, Lombardy, 46100, Italy
Osp. San Raffaele; Dip. Di Oncoematologia
Milan, Lombardy, 20132, Italy
Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
Milan, Lombardy, 20133, Italy
Irccs Policlinico San Matteo; Divisione Di Ematologia
Pavia, Lombardy, 27100, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano, Lombardy, 20089, Italy
Università Cattolica Del Sacro Cuore S.S. Giovanni Paolo Ii; Uoc Di Onco-Ematologia
Campobasso, Molise, 86100, Italy
Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
Alessandria, Piedmont, 15121, Italy
Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
Novara, Piedmont, 28100, Italy
Ospedale Roberto Binaghi; Centro trapianti di midollo osseo
Cagliari, Sardinia, 09126, Italy
Osp. San Francesco; Ematologia e CTMO
Nuoro, Sardinia, 08100, Italy
ARNAS Garibaldi; Ematologia
Catania, Sicily, 95122, Italy
Az. Osp. Papardo; Struttura Complessa Di Ematologia
Messina, Sicily, 98165, Italy
ARNAS-Ospedale Civico Maurizio Ascoli; Unità Operativa di Oncologia Medica
Palermo, Sicily, 90127, Italy
Azienda Uni Ria Policlinico P. Giaccone ; Divisione Di Ematologia E Trapianto
Palermo, Sicily, 90127, Italy
Ospedale Gen.Le Prov.Le 'C.G.Mazzoni'; Ematologia
Ascoli Piceno, The Marches, 63100, Italy
Ospedale di Civitanova Marche; Medicina Interna
Civitanova Marche, The Marches, 62012, Italy
Ospedale di Macerata; Medicina Generale
Macerata, The Marches, 62100, Italy
Ospedale Santa Chiara; Unita Operativa Di Ematologia
Pisa, Tuscany, 56100, Italy
USL 4 di Prato - Nuovo Ospeale di Prato
Prato, Tuscany, 59100, Italy
A.O. Santa Maria Terni; S.C. Oncoematologia
Terni, Umbria, 05100, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padua, Veneto, 35128, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2013
First Posted
June 28, 2013
Study Start
July 31, 2013
Primary Completion
May 28, 2019
Study Completion
May 28, 2019
Last Updated
August 13, 2020
Results First Posted
August 13, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).