Randomised Study Comparing an Immuno-Chemotherapy with 6 Cycles of the Monoclonal anti-CD20 Antibody Rituximab in Combination with 6 Cycles of Chemotherapy with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) at 21-day Intervals or 14-day Intervals, both with or without consolidating Radiotherapy of Large Tumour Masses (≥ 7.5 cm) and/or Extranodal Involvement in Patients with Aggressive CD20+ B-Cell Lymphoma Aged 18 to 60 Years with Age-adjusted IPI=1 (all) or IPI=0 with Bulky Disease (≥ 7.5 cm) - UNFOLDER

• Conditions: Aggressive CD20 positive Non Hodgkin's Lymphoma in patients aged 18-60 years: all patients with age-adjusted IPI =1 and those with age-adjusted IPI =0, in the concurrent presence of bulky disease only (>= 7.5 cm); MedDRA version: 9.1Level: LLTClassification code 10036710Term: Primary mediastinal large B-cell lymphoma; MedDRA version: 9.1Level: LLTClassification code 10029460Term: Nodal marginal zone B-cell lymphoma; MedDRA version: 9.1Level: LLTClassification code 10061275Term: Mantle cell lymphoma; MedDRA version: 9.1Level: LLTClassification code 10012818Term: Diffuse large B-cell lymphoma

• Registration Number: EUCTR2005-005218-19-IT
• Lead Sponsor: G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1072

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 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 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 - aggressive marginal zone lymphoma (monocytoid) - Mantle-cell lymphoma (blastoid) 4. 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) 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. >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.

Study & Design

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