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A Randomized Study Comparing Maintenance Therapy With Subcutaneous Rituximab Continued Until Progression With Observation Only in Patients With Relapsed or Refractory, Indolent Non-Hodgkin's Lymphoma Who Completed and Responded to Rituximab-based Immunochemotherapy Induction and Initial 2-year Rituximab Maintenance Therapy Administered Subcutaneously
This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's lymphoma (NHL). All participants will receive induction therapy with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously \[IV\] in Cycle 1, then 1400 mg subcutaneous \[SC\] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II period and will be followed for at least 15 months. Anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University "Mother Theresa" Hospital Center; Oncology Department
Tirana, Albania
CEMIC Saavedra
Buenos Aires, Argentina
Instituto Damic
Córdoba, Argentina
Hospital Privado de Comunidad; Oncology
Mar del Plata, Argentina
Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie
Graz, Austria
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck, Austria
Kepler Universitätskliniken GmbH - Med Campus III; III. Medizinische Abteilung
Linz, Austria
Landeskrankenhaus Rankweil; Interne E
Rankweil, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
Vienna, Austria
Centro de Tratamento Oncologico - CETRON
Rio de Janeiro, Rio de Janeiro, Brazil
Start Date
December 20, 2011
Primary Completion Date
June 2, 2018
Completion Date
June 2, 2018
Last Updated
August 6, 2019
692
ACTUAL participants
Chemotherapy (Induction Period)
DRUG
Rituximab
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT06667687
NCT05623982
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03314974