A Phase II Study of the FIL on Elderly Frail Patients With DLBCL

Inclusion Criteria

• •1. Histologically proven CD20 positive Diffuse Large B-cell Lymphoma according to WHO classification (local pathologist)
• •2. Age ≥ 70 years
• •3. Previously untreated
• •4. CGA assessment performed before starting treatment
• •5. FRAIL patients defined as follows
• •Age \> 80 years (with UNFIT profile):
• •ADL ≥ 5 residual functions and/or IADL ≥ 6 residual functions and/or CIRS: 0 comorbidity of grade 3-4 and 5-8 comorbidities of grade 2
• •Age \< 80 (ONLY one of the following criteria):
• •ADL ≤ 4 residual functions IADL ≤ 5 residual functions CIRS: 1 comorbidity of grade 3-4 or \> 8 comorbidities of grade 2
• •6. Ann Arbor Stage I - IV (Appendix F)
• •7. At least one bi-dimensionally measurable lesion defined as \> 1.5 cm in its largest dimension on CT scan
• •8. ECOG performance status of 0- 3 (Appendix E)
• •9. No active hepatitis C virus (HCV) infection. In case of HCV positivity HCV-RNA is required. Only patients with HCV-RNA negative are accepted.
• •10. Adequate hematologic function (unless caused by bone marrow infiltrate), defined as follows:
• •* Hemoglobin \> 10 g/dL
• •* WBC \> 2500/mmc with PMN \> 1000/ mmc
• •* Platelets count ≥ 75000/mmc
• •* Creatinine clearance ≥ 10 mL/min
• •11. Ability and willingness to comply with the study protocol procedure
• •12. Life expectancy \> 6 months
• •13. Patients must give written informed consent.
• •14. Male subjects must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following investigational product discontinuation, even if he has undergone a successful vasectomy.