open label, single arm, phase ii study using r-comp in elderly patients with aggressive nhl.

Conditions: Aggressive Non-Hodgkin's Lymphoma in the Elderly.

Summary: to evaluate the safety and efficacy of r-comp in elderly patients with advanced aggressive nhl. myocet (non-pegylated liposomal doxorubicin) replaces conventional doxorubicin in the r-chop regimen.

to evaluate the duration of remission, disease free survival and 2-year survival of r-comp in first line therapy of elderly patients with advanced aggressive nhl. to evaluate the tolerability of r-comp in first line therapy of elderly patients with advanced aggressive nhl.

Eligibility criteria:
inclusion criteria: * diffuse large b-cell lymphoma (dlbcl), and their morphologic variants and subtypes, i.e. centroblastic lymphoma, immunoblastic lymphoma, t-cell rich/b-cell lymphoma, anaplastic large b-cell lymphoma, mediastinal (thymic) large b-cell lymphoma; * primary diffuse large b-cell lymphoma of malt (incorrectly defined as high-grade malt lymphoma); * marginal zone b-cell lymphoma with coexisting areas of dlbcl; * age of ≥60 years; * clinical stage at diagnosis: i a bulky - iv b; * cd20 positivity; * serum negativity for hbsag and hcv except for those with no sign of active viral replication, assessed by hcv-rna copies; * absolute neutrophil count (anc) ≥1.5x109/l, and platelet count ≥100x109/l (unless both are attributed directly to bone marrow involvement by lymphoma or auto-immune disease secondary to lymphoma); * serum creatinine ≤130μm/l, serum bilirubin ≤2.5xuln aspartate amino-transferase (ast/got), ≤2.5xuln alanine amino-transferase (alt/gpt) ≤2.5xuln, and alkaline phosphatase ≤4 times the upper limit of normal (unless the increase is attributed directly to the presence of tumour by the investigator) * left ventricular ejection fraction (lvef) ≥50%; * ecog performance status 0-2; * at least one measurable lesion is mandatory; * written informed consent given at time of registration; * males and females (both males and females of childbearing potential must agree to use adequate contraception for the duration, and for 3 months after the completion, of the treatment). exclusion criteria: * clinical stage i non-bulky, or cs iia with less than three sites of disease involved (patients with stage iib are eligible, regardless of the number of sites involved); * tumour involvement of cns; * indolent lymphoma transformed in more aggressive histological type, even if never previously treated; * mantle cell lymphoma, peripheral t cell lymphoma and their variants; * aggressive non-hodgkin's lymphoma in transplanted patient; * clinically significant secondary cardiovascular disease, e.g. uncontrolled hypertension, (resting diastolic blood pressure \>115 mmhg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure nyha class iii-iv; * evidence of any severe active acute or chronic infection; * concurrent malignancy or history of other malignancy, except basal cell carcinoma of the skin (bcc) and in-situ cervical carcinoma (cin) / myelodysplastic syndrome; * hbsag, hiv-positive, or hcv-rna-positive patients; * inability to comply with study procedures; * prior cns lymphoma; * prior radiation to non-cns lymphoma mass(es) as a treatment for lymphomas; * history of allergic reaction to anthracyclines, eggs, and egg products or known sensitivities, or history of unusual reaction, to other components of, or treatments similar to, the investigational treatment regimen; * presence of other medication that may interfere with study treatment or the action of the investigational product or confuse the assessment of study results * pregnant women or nursing mothers; * participation in an investigational drug study within 4 weeks prior to study entry.