Randomised Study Comparing 4 and 6 Cycles of Chemotherapy with CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 21-day Intervals, both with 6 Cycles of Immunotherapy with the Monoclonal anti-CD20 Antibody Rituximab in Patients with Aggressive CD20-positive B-Cell Lyphoma Aged 18 to 60 Years with no Risk Faktor (Age-adjusted IPI=0) and no Bulky Disease (Diameter <7,5cm) - FLYER 6-6/6-4-Study

• Conditions: Patients with Aggressive CD20-positive B-Cell Lymphoma; MedDRA version: 9.1Level: HLTClassification code 10012819Term: Diffuse large B-cell lymphomas

• Registration Number: EUCTR2005-005217-38-IT
• Lead Sponsor: German High-Grade non- Hodgkin's Lynphoma Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-18
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 622

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 <7.5 cm in diameter) 3. Histology: Diagnosis of a CD20-positive aggressive B-cell lymphoma, confirmed by an excisional biopsy of a lymph node or by a sufficiently extensive biopsy of an 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 IIIb 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 Mantle-cell lymphoma (blastoid) aggressive marginal zone lymphoma (monocytoid) T-NHL: T-NHL cannot be included in this study! The respective patients should be included in phase-II studies of the DSHNHL instead which have been specially designed for this patient cohort (please contact the study secretariat). 4. Performance status: Performance status ECOG 0-1 time of randomisation; definitions see appendix 13.10. A performance status ECOG >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

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. Risk factor according to age-adjusted IPI (LDH >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) 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. We would recommend the inclusion of the respective patients in one of the studies of the German study group GIT-NHL (Prof. Dr. Berdel, Dr. Koch, Münster) and German Study Group PCNSL (Prof. Dr. Thiel, Berlin, Prof. Dr. Weller, Tübingen) respectively. Patients with lymphoblastic lymphoma should be referred to the multicentre ALL study (Prof. Dr. Hoelzer, Frankfurt).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 time to treatment failure (TTF), calculated from the time of randomisation