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

G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI0 sites1,072 target enrollmentJuly 18, 2008

Overview

No summary available.

Registry

who.int

Start Date

July 18, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI

•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

•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.