Patients with untreated aggressive CD20+ Non-Hodgkin?s Lymphoma aged 18 to 60 years without major accompanying disorders with no risk factor according to IPI and no bulky disease (<7,5cm) MedDRA version: 14.1 Level: PT Classification code 10003899 Term: B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
German High Grade Non-Hodgkins Lymphoma group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 60 years 2. Risk group: good-prognosis, very favourable (age-adjusted IPI=0; for definitions see appendix 13.11), no bulk (largest single or conglomerate tumour 1 (2-4) is a risk factor according to IPI and thus a reason for exclusion from this study! 5. Declaration of participation provided by the study centre and the written consent of 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) no 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)heart: angina pectoris CCS >2, cardiac failure e.g. NYHA >2 and/or EF 2 times the upper reference limit • liver: bilirubin >2 times the upper reference limit, aspartate transaminase (AST, SGOT) or alanine transaminase (ALT, SGPT) >3 x institutional upper reference limit • uncontrollable diabetes mellitus (prephase treatment with prednisone) 3. Platelets nl, stage III/IV, ECOG >1) 14. Evidence of bulk (single or conglomerate tumour = 7.5 cm) 15. CNS involvement of lymphoma (intracerebral, meningeal, intraspinal) or primary CNS lymphoma 16. MALT lymphoma 17. Planned radiotherapy of extranodal involvement 18. Non-application of inclusion criteria. Patients with primary ZNS involvement or MALT lymphoma should not be included in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reducing toxicity while maintaining efficacy of a combined immuno-chemotherapy with 6 cycles of the monoclonal anti-CD20 antibody rituximab by decreasing the number of cycles of chemotherapy with CHOP-21 from six to four.;Secondary Objective: Comparison of short-term 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 the time of randomisation Secondary endpoints are CR rate, rate of primary progression under therapy, survival, tumour control, disease-free survival, toxicity, parameters of health cost, adherence to protocol, and analysis of relapse. | — |
Countries
Denmark, Italy
Outcome results
None listed