Comparison of HD Chemotherapy Followed by Auto-transplant and R-CHOP in High Risk Patients With DLBCL.
Condition: Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Intervention: Rituximab-HDS; Rituximab-CHOP
Intervention description: Rituximab-HDS; Rituximab-CHOP
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: DLBCL; R-HDS; R-CHOP14

Summary:

      Multicentric randomized phase III study comparing high doses of chemotherapy with Rituximab
      followed by auto-transplant HPC versus CHOP plus Rituximab as first line therapy in high risk
      patients with DLBCL Non-Hodgkin's lymphomas.
    

Eligibility criteria:

        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. The
             disease stage criteria must be documented with instrumental examinations and bone
             marrow 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 the
             understanding that consent may be withdrawn by the subject at any time without
             prejudice to future medical care. Patients must to be informed on the risk of
             sterility and they must agree to use contraception for the duration of the study. Male
             subject 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 not
             controlled by therapy, IMA in the last six months, hearth disease NYHA class III or
             IV), hepatopathy not related to the lymphoma (bilirubin >= 2 mg/dl, ALT >= 2.5 times
             the normal value, alkaline phosphatase >=2.5 times the upper limit), kidneys
             insufficiency 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 viral
             replication documented with HBV-DNA are not excluded from randomization; patients with
             HBV+ can be enrolled after receiving prophylaxis with lamivudina one week before
             starting 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 any
             serious 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 this
             clinical study (i.e. the signing of the informed consent, therapy compliance).

          -  Inability to attend follow-up visits.