Indolent Non-Hodgkin Lymphomas, in particular follicular lymphomas, as well as marginal zone lymphomas, immunocytomas (Waldenström’s macroglobulinaemia) and mantle cell lymphomas
Conditions
Interventions
Trade Name: Mabthera(R)
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Rituximab
CAS Number: none
Current Sponsor code: none
Other descriptive name: none
Concentration unit: mg/ml mi
Sponsors
StiL Forschungs-GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histological verified CD20-positive B-cell-lymphoma of the following entities: follicular lymphoma immunocytoma / Waldenström’s macroglobulinaemia and small-cell lymphocytic lymphoma without leukaemic phase of the disease marginal zone lymphoma mantle cell lymphoma no pretreatment with cytostatics, interferon or monoclonal antibodies in need for therapy, except mantle cell lymphoma stages III or IV or stage II bulky disease performance status (WHO) 0-2 minimum age 18 years maximum age 80 years negative pregnancy test, contraception for women of child-bearing age histology not older than 6 month – mandatory patients written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 424
Exclusion criteria
Exclusion criteria: Patients not meeting the criteria of E 3 Potential curative radiotherapy as alternative option Pre-treatment except singular locally confined radiotherapy (radiation field not larger than two adjacent lymph node regions) concomitant disease which impedes the study equitable therapy like: severe, medicinal uncontrollable hypertension, severe disorder of the heart or lung or liver or kidney, except if caused by the lymphoma patients with proven HIV-infection active and replicating hepatitis-infection severe psychiatric disorder missing or anticipation of missing compliance Pregnant or breastfeeding women Patients with a second malignoma or malignant disease in their history, if surgery is anticipated not to be curable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In follicular lymphomas: determination and comparison of progression free survival (PFS) with Bendamustine plus Rituximab (B-R) followed by a maintenance therapy with Rituximab over 2 years every 2 months versus Bendamustine plus Rituximab followed by a maintenance therapy with Rituximab over 4 years every 2 months. In mantle cell lymphomas, marginal zone lymphomas, immunocytomas (Waldenström´s macroglobulinaemias): determination and comparison of progression free survival with Bendamustine plus Rituximab followed by observation versus Bendamustine plus Rituximab followed by a maintenance therapy with Rituximab over 2 years every 2 months.;Secondary Objective: Efficacy, overall response rates and duaration, event-free-survival, progression-free-survival, disease-free-survival, overall-survival, toxicity, acute and long-term toxicity, incidence of infectious complications.;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: Follow up until progression is documented | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Remission rates and duration EFS, PFS, DFS, OS, Toxicity: acute, long term, infectous complications, immune status;Timepoint(s) of evaluation of this end point: Every two months during maintenance, every 6 months after completion of maintenance | — |
Countries
Austria, Germany
Contacts
Public ContactJürgen Barth
StiL Study Head Office
Outcome results
None listed