Randomized study of intensified CHOP plus Rituximab (R-CHOP given every 14 days: R-CHOP 14) versus CHOP plus Rituximab given every 21 days (R-CHOP 21) and randomized study of frontline-prophylatic Darbepoietin alpha treatment versus usual symptomatic treatment of anemia in non previously treated patients aged from 60 to 80 years, with CD20+ diffuse large B-cell lymphoma

Conditions: Study of frontline-prophylatic darbepoetin alpha treatment versus usual symptomatic treatment of anemia in non previously treated patients aged 60 to 80 years, with CD20+ diffuse large B-cell lymphoma
MedDRA version: 9.1Level: HLTClassification code 10012819Term: Diffuse large B-cell lymphomas

Registration Number: EUCTR2007-001519-52-PT

Lead Sponsor: Groupe d'Etudes des Lymphomes de l'Adult

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO Classification). DLBCL with some small cell infiltration in bone marrow or lymph node may be included; Aged from 60 to 80; patient not previously treateed; Ann Arbor stage II, III and IV;Age-adjusted IPI 1, 2 or 3; ECOG Performance status 0 to 2; with a minimum life expectancy of 3 months; negative HIV, HBV and HCV serologies « weeks (except after vacination) and having previously signed a written informed consent.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any other histological type of lymphoma; Any history of threated or non-treated indolent lymphoma; Central nervous system or meningeal involvement by lymphoma; Contra-indication to any drug contained in the chemotherapy regimens; Any serious co-morbid active disease (according to the investigator's decision); Poor renal function (creatinin > 150 mmol/l), poor hepatic function (total bilirrubin level > 30 mmol/l, transaminases > 2.5 maximum normal level) unless these abnormalitiesare related to the lymphoma; Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l, unless related to none marrow infiltration; Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma; Uncontrolled hypertension, Myocardial infarction during the last 3 months or unstable coronary disease or uncontrolled cardiac insuffiency; Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study; Adult patient under tutelage.