Prospective Randomized Multicenter Study in First-line Treatment of Advanced progredIeNT Follicular And Other IndoleNt and Mantle Cell Lymphomas
Overview
- Phase
- Phase 3
- Intervention
- Rituximab
- Conditions
- Follicular Lymphomas
- Sponsor
- Jurgen Barth
- Enrollment
- 1272
- Locations
- 1
- Primary Endpoint
- Progression free survival
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to determine if an extended maintenance therapy with Rituximab in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has advantages compared to a shorter or no maintenance therapy.
Detailed Description
Results from several randomised studies show a clinical benefit of a maintenance therapy with rituximab in follicular lymphomas. The advantage of a maintenance therapy in other indolent and mantle cell lymphomas is - due to the lower incidence of these diseases- not well investigated. This study tries to determine the significance of an extended maintenance therapy with rituximab in follicular lymphomas and the significance of a maintenance therapy other indolent and mantle cell lymphomas compared to observation.
Investigators
Jurgen Barth
Professor Mathias Rummel
University of Giessen
Eligibility Criteria
Inclusion Criteria
- •Patients with histological verified CD20-positive B-Cell-Lymphoma of the following entities:
- •Follicular Lymphoma Grade 1 and 2
- •Lymphoplasmocytic lymphoma / Immunocytoma (Morbus Waldenström) and small cell lymphocytic lymphoma (CLL without leukemic hemogram)
- •Marginal zone lymphoma, nodal and extra nodal
- •Mantle cell lymphoma
- •No prior therapy with cytotoxics, interferon or monoclonal antibodies
- •Need for therapy, except mantle cell lymphomas
- •Stadium III or IV or Stadium with II bulky disease (\> 7 cm diameter, or 3 lesions \> 5 cm)
- •General condition WHO 0-2
- •Age min. 18 years, max. 80 years
Exclusion Criteria
- •Patients not meeting the inclusion criteria above
- •Possibility of a primary radiation therapy with curative intention
- •Pretreatment, except a single, localized radiation therapy (radiation field not larger than 2 adjacent lymph node regions)
- •Co-morbidities, excluding a therapy according to the protocol:
- •severe, medicinal not adjustable hypertension
- •severe limited capacity of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver and kidneys (creatinin \> 2 mg/dl, GOT and GPT or bilirubin 3 x ULN), except if caused by lymphoma
- •severe, medicinal not adjustable diabetes mellitus
- •active autoimmune disease
- •active infection, requiring antibiotic therapy
- •Patients with proven HIV-infection
Arms & Interventions
Rituximab
Follicular Lymphomas: Rituximab 375 mg/m² for additional 2 years after 2 years of standard maintainance All other lymphomas: Rituximab 375 mg/m² for 2 years as maintainance. From 2014 only Morbus Waldenstroem: Rituximab 1.400 mg absolute s. c. injection
Intervention: Rituximab
Standard
Rituximab / Observation
Intervention: Rituximab / observation
Outcomes
Primary Outcomes
Progression free survival
Time Frame: 5 years and ongoing
Time from randomization until progress or death of any course
Secondary Outcomes
- Remission rate and duration; event free-, progression free-, disease free- and over all survival(5 years and ongoing)