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)

NCT ID: NCT01889069

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2019-05-28

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab

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, 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.

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

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

Intervention Type: DRUG

Cyclophosphamide will be administered as per standard local practice as a part of standard chemotherapy regimen.

Vincristine

Intervention Type: DRUG

Vincristine will be administered as per standard local practice as a part of standard chemotherapy regimen.

Doxorubicin

Intervention Type: DRUG

Doxorubicin will be administered as per standard local practice as a part of standard chemotherapy regimen.

Prednisone

Intervention Type: DRUG

Prednisone will be administered as per standard local practice as a part of standard chemotherapy regimen.

Bendamustine

Intervention Type: DRUG

Bendamustine will be administered as per standard local practice as a part of standard chemotherapy regimen.

Interventions

Rituximab

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.

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide will be administered as per standard local practice as a part of standard chemotherapy regimen.

Intervention Type: DRUG

Vincristine

Vincristine will be administered as per standard local practice as a part of standard chemotherapy regimen.

Intervention Type: DRUG

Doxorubicin

Doxorubicin will be administered as per standard local practice as a part of standard chemotherapy regimen.

Intervention Type: DRUG

Prednisone

Prednisone will be administered as per standard local practice as a part of standard chemotherapy regimen.

Intervention Type: DRUG

Bendamustine

Bendamustine will be administered as per standard local practice as a part of standard chemotherapy regimen.

Intervention Type: DRUG

Other Intervention Names

MabThera; Rituxan

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

Bari, Apulia, Italy

Azienda ospedaliera oo rr di foggi; Hematology

Foggia, Apulia, Italy

Irccs Crob

Rionero in Vulture, Basilicate, Italy

Azienda Ospedaliera Bianchi-Melacrino-Morelli; Unità Operativa di Ematologia

Reggio Calabria, Calabria, Italy

Azienda Ospedaliera S.G. Moscati; Divisione Ematologia

Avellino, Campania, Italy

Asl ce - p.o. Avers; Uoc ematologia

Aversa, Campania, Italy

A.O. San Sebastiano; U.O.C. Oncologia

Caserta, Campania, Italy

Seconda università degli studi di napoli; Medicina clinica e sperimentale magrassi - lanzara

Napoli, Campania, Italy

Osp. Santa Maria Goretti; Ematologia

Latina, Lazio, Italy

Ospedale S. Eugenio; Divisione Di Ematologia

Rome, Lazio, Italy

Regina Elena National Cancer Institute; Hematology

Rome, Lazio, Italy

Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo

Rome, Lazio, Italy

Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol

Rome, Lazio, Italy

Azienda Ospedaliera S. Giovanni Addolorata; UOC Ematologia

Rome, Lazio, Italy

ASL Viterbo; Presidio Ospedaliero di Ronciglione; UOC Ematologia

Ronciglione, Lazio, Italy

Ospedale Valduce;U.O.S. Oncologia Ed Ematologia

Como, Lombardy, Italy

ASST DI CREMA; U O Oncologia Medica

Crema, Lombardy, Italy

ASST DI LECCO; Oncologia Medica

Lecco, Lombardy, Italy

Az. Osp. Carlo Poma; Divisione Di Oncologia Medica

Mantova, Lombardy, Italy

Osp. San Raffaele; Dip. Di Oncoematologia

Milan, Lombardy, Italy

Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico

Milan, Lombardy, Italy

Irccs Policlinico San Matteo; Divisione Di Ematologia

Pavia, Lombardy, Italy

Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

Rozzano, Lombardy, Italy

Università Cattolica Del Sacro Cuore S.S. Giovanni Paolo Ii; Uoc Di Onco-Ematologia

Campobasso, Molise, Italy

Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia

Alessandria, Piedmont, Italy

Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad

Novara, Piedmont, Italy

Ospedale Roberto Binaghi; Centro trapianti di midollo osseo

Cagliari, Sardinia, Italy

Osp. San Francesco; Ematologia e CTMO

Nuoro, Sardinia, Italy

ARNAS Garibaldi; Ematologia

Catania, Sicily, Italy

Az. Osp. Papardo; Struttura Complessa Di Ematologia

Messina, Sicily, Italy

ARNAS-Ospedale Civico Maurizio Ascoli; Unità Operativa di Oncologia Medica

Palermo, Sicily, Italy

Azienda Uni Ria Policlinico P. Giaccone ; Divisione Di Ematologia E Trapianto

Palermo, Sicily, Italy

Ospedale Gen.Le Prov.Le 'C.G.Mazzoni'; Ematologia

Ascoli Piceno, The Marches, Italy

Ospedale di Civitanova Marche; Medicina Interna

Civitanova Marche, The Marches, Italy

Ospedale di Macerata; Medicina Generale

Macerata, The Marches, Italy

Ospedale Santa Chiara; Unita Operativa Di Ematologia

Pisa, Tuscany, Italy

USL 4 di Prato - Nuovo Ospeale di Prato

Prato, Tuscany, Italy

A.O. Santa Maria Terni; S.C. Oncoematologia

Terni, Umbria, Italy

IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

Padua, Veneto, Italy

Countries

Italy

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2013-000647-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28881

Identifier Type: -

Identifier Source: org_study_id