Randomised Study Comparing an Immuno-Chemotherapy with 6 Cyclesof the Monoclonal anti-CD20 Antibody Rituximab in Combination with6 Cycles of Chemotherapy with CHOP (Cyclophosphamide, Doxorubicin, Vincristine,and Prednisone) at 21-day Intervals or 14-day Intervals, both with or withoutconsolidating Radiotherapy of Large Tumour Masses (= 7.5 cm) and/orExtranodal involvement in Patients with Aggressive CD20+ B-Cell LymphomaAged 18 to 60 Years with Age-adjusted IPI=1 (all) or IPI=0 withBulky Disease (= 7.5 cm) Short Title: UNFOLDER 21/14 Study - UNFOLDER 21/14 study
- Conditions
- 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
- Registration Number
- EUCTR2005-005218-19-DK
- Lead Sponsor
- German High Grade Non-Hodgkin's Lymphoma group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1072
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
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 < 100 000/mm3, leukocytes < 2 500/mm3
4.Known hypersensitivity to the medications to be used
5.Known HIV-positivity
6.Active hepatitis infection
7.Suspected poor patient compliance
8.Simultaneous participation in other treatment studies
9.Prior chemo- or radiotherapy for previous disorder
10.Prior immunosuppressive treatment with cytostatics
11.Other concomitant tumour disease and/or tumour disease in the past 5 years (except carcinoma in situ and basalioma of the skin)
12.Pregnancy and lactation period
13.>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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>Secondary endpoints are CR rate, survival, tumour control, disease-free survival, toxicity, parameters of health costs and adherence to protocol, and analysis of relapse.<br>
- Secondary Outcome Measures
Name Time Method