Comparison of HD Chemotherapy Followed by Auto-transplant and R-CHOP in High Risk Patients With DLBCL.

Inclusion Criteria:

• Diagnosis of DLBCL CD20+.

• Patients with Ann Arbor classification B-bulk >= II

• Patients of age between 18-65 with age-adjusted IPI 2-3 and ECOG performance status 0-3 or patients of age 61-65 with IPI 3, 4, 5 and ECOG performance status 0-2. Thedisease stage criteria must be documented with instrumental examinations and bonemarrow biopsy.

• Hematology parameters one week before starting study as follows: Hb >= 9 g/dl, WBC >= 3 x 10exp9/l, neutrophils >= 1.5 x 10exp9/l, PLT >= 100 x 10exp9/l.

• Patients with pulmonary DLCO >= 50% and cardiac EF >= 40%.

• Voluntary written informed consent must be signed before recruitment, with theunderstanding that consent may be withdrawn by the subject at any time withoutprejudice to future medical care. Patients must to be informed on the risk ofsterility and they must agree to use contraception for the duration of the study. Malesubject have to the opportunity of freezing seminal fluid.

Exclusion Criteria:

• Diagnosis different from that describe above.

• Patients with concomitant, serious and uncontrolled illnesses such as cardiopathies (i.e. congestive cardiopathy, ischemic hearth disease, cardiac arrhythmia notcontrolled by therapy, IMA in the last six months, hearth disease NYHA class III orIV), hepatopathy not related to the lymphoma (bilirubin >= 2 mg/dl, ALT >= 2.5 timesthe normal value, alkaline phosphatase >=2.5 times the upper limit), kidneysinsufficiency not related to the lymphoma (creatinine >=2 mg/dl).

• Patients affected by opportunistic infections or with positive serology for HIV, HCV,HbsAg (cases with normal levels of hepatic enzymes and not showing active viralreplication documented with HBV-DNA are not excluded from randomization; patients withHBV+ can be enrolled after receiving prophylaxis with lamivudina one week beforestarting chemotherapy. These patients should be monitored twice a month for HbsAg,HBCab, HBV-DNA).

• Patients which have or have had another type of cancer exception made for skin cancers (melanoma and "in situ" cervical cancer not included).

• Patient with a history of anaphylaxes or more generally patients which have had anyserious allergic reaction after serum infusion.

• Patient with uncontrolled epilepsy, CNS disorders or psychiatric problems which,according to the investigator, is likely to interfere with participation in thisclinical study (i.e. the signing of the informed consent, therapy compliance).

• Inability to attend follow-up visits.