Patients with untreated aggressive CD20+ Non-Hodgkin’s Lymphoma aged 18 to 60 years without major accompanying diseases with IPI= 1 (all) or IPI= 0 and bulky disease (=7.5cm
Conditions
Sponsors
German High Grade Non-Hodgkin's Lymphoma group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 60 years 2. Risk group: good-prognosis, less favourable 1. (age-adjusted) IPI=1: all patients 2. (age-adjusted) IPI=0: only patients with bulky disease (for definitions see Appendix 13.9, largest single or conglomerate tumour must be = 7.5 cm in diameter) 3. Histology: Diagnosis of a untreated CD20-positive aggressive B-cell lymphoma, confirmed by excisional biopsy of a lymph node or by a sufficiently extensive biopsy of extranodal manifestation if there is no lymph node involvement. It will be possible to treat the following entities in this study: B-NHL: follicular lymphoma stage III°b follicular lymphoma stage III° and diffuse large B-cell lymphoma diffuse large B-cell lymphoma centroblastic immunoblastic plasmoblastic anaplastic large cell T-cell-rich B-cell lymphoma primary effusion lymphoma intravasal B-cell lymphoma primary mediastinal B-cell lymphoma Burkitt-like lymphoma Burkitt lymphoma aggressive marginal zone lymphoma (monocytoid) Mantle-cell lymphoma (blastoid) 4. Performance status: Performance status ECOG 0-2 at the time of randomisation. 5. Declaration of participation provided by the study centre and the written consent by the patient 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 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Already initiated lymphoma treatment (except for prephase treatment according to this protocol) 2. Serious accompanying disorder or impaired organ function (in particular impaired left ventricular function or severe cardiac arrhythmias) 3. Platelets 1 Risk factor according to age-adjusted IPI (LDH >UNV, stage III/IV, ECOG >1) 14. CNS involvement of lymphoma (intracerebral, meningeal, intraspinal) 15. MALT lymphoma 16. Non-application of inclusion criteria. Patients with primary CNS involvement or MALT lymphoma should not be included in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement of treatment outcome respectively reduction in side effects of a combined immuno-chemotherapy with six cycles of the monoclonal anti-CD20 antibody rituximab by shortening therapy intervals from three to two weeks or else improvement by radiotherapy (39,6 Gy) of bulky disease.;Secondary Objective: Relevance of consolidating radiotherapy of qualifying extranodal involvements. Comparison of short and long-term side effects, quality of life and costs;Primary end point(s): The main endpoint is the time to treatment failure (TTF), calculated from randomisation Secondary endpoints are CR rate, survival, tumour control, disease-free survival, toxicity, parameters of health costs and adherence to protocol, and analysis of relapse. | — |
Countries
Denmark, Italy
Outcome results
None listed