Prospective Multicenter Dose Finding Phase II Pilot Trial to Evaluate Efficacy and Safety of LR-CHOP21 for Elderly Patients With Untreated Diffuse Large B Cell Lymphoma

Inclusion Criteria

• •1. Understand and voluntarily sign an informed consent form
• •2. Able to adhere to the study visit schedule and other protocol requirements
• •3. Histologic subtypes as follows:
• •* CD20 positive Diffuse large B-Cell lymphoma
• •* CD20 positive Follicular grade IIIb
• •4. Age 60-80
• •5. Untreated patients. In patients with bulky mass or systemic symptoms or compressive disease or rapidly progressive adenopathies a pre-study treatment is allowed with steroids and/or a single dose of Vincristine 1.4 mg/mq (max 2) in the seven days prior the start of the study treatment
• •6. Measurable and/or evaluable disease
• •7. Ann Arbor stage II, III, IV
• •8. International Prognostic Index at low-intermediate, intermediate-high, high risk (2/3/4-5)
• •9. Adequate haematological counts: ANC \> 1.5 x 109/L and platelet count \> 75 x 109/L unless due to bone marrow involvement
• •10. Conjugated bilirubin up to 2 x UNL
• •11. Alkaline phosphatase and transaminases up to 2 x UNL
• •12. Creatinine clearance \> 50 ml/min
• •13. HIV negativity
• •14. HCV negativity
• •15. HBV negativity or patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
• •16. Cardiac ejection fraction (MUGA scan or echocardiography) \> 45%
• •17. Non peripheral neuropathy or CNS disease. Non testicular Lymphoma
• •18. Life expectancy \> 6 months
• •19. Performance status \< 2 according to ECOG scale
• •20. Comprehensive geriatric assessment (CGA) as outlined in Appendix 15 showing absence of any impairment in activity of daily living (ADL), of any condition defining a geriatric syndrome, and of any grade 4 comorbidity or of more than three grade 3 comorbidities according to CIRS-G scale
• •21. Disease free of prior malignancies for ≥ 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
• •22. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: for at least 28 days before starting study drug;while participating in the study; for at least 28 days after discontinuation from the study
• •* The two methods of reliable contraception must include one highly effective method (i.e., intrauterine device (IUD), hormonal \[birth control pills, injections, or implants\], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e., latex condom, diaphragm, cervical cap)
• •* FCBP must be referred to a qualified provider of contraceptive methods if needed