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
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.
Inclusion Criteria:
Exclusion Criteria:
Innsbruck, 6020, Austria
Vienna, 1090, Austria
Passo Fundo, Rio Grande do Sul 99010-260, Brazil
Dresden, 01307, Germany
Dresden, 01307, Germany
Greifswald, 17475, Germany
Halle, 06110, Germany
München, 81675, Germany
Bari, Apulia 70124, Italy
Naples, Campania 80131, Italy
Naples, Campania 80131, Italy
Modena, Emilia-Romagna 41100, Italy
Udine, Friuli Venezia Giulia 33100, Italy
Rome, Lazio 00161, Italy
Milan, Lombardy 20162, Italy
Turin, Piedmont 10126, Italy
Via S. Sofia 78, Sicily 95123, Italy
Bolzano, Trentino-Alto Adige 39100, Italy
Stavanger, 4011, Norway
Târgu Mureş, 540136, Romania
Moscow, 115478, Russia
Badalona, Barcelona 08915, Spain
Oviedo, Principality of Asturias 33011, Spain
San Cristóbal de La Laguna, Tenerife 38320, Spain
San Cristóbal de La Laguna, Tenerife 38320, Spain
Jaén, 23007, Spain
Madrid, 28050, Spain
Zurich, 8091, Switzerland
Istanbul, 34300, Turkey (Türkiye)