Multicentric Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Patients With Stage II-IV Follicular Lymphoma

Launched by FONDAZIONE ITALIANA LINFOMI - ETS · Oct 16, 2008

Keywords

ClinConnect Summary

Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP - Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histological DIAGNOSIS of B cell follicular lymphoma
• • 2. ECOG performance status 0-2
• • 3. Age range 18-75
• • 4. Ann Arbor Stage: II-IV
• • 5. Assessment of pathology with diagnostics biopsy
• 6. Presence of one of these criteria:
• • B Sistemic symptoms B
• • Extranodale pathology
• • Cytopenia
• • Splenomegaly
• • Leukemia
• • Serous effusion
• • Ves \> 20 mm/h
• • Ldh \> normal value
• • Nodale or extranodal mass \> 7 cm
• • 3 or more nodal sites \> 3 cm
• • Adenopatic syndrome
• • 7. LVEF \> 50%
• • 8. Normal hepatic (bilirubin \< 1.5 mg/dl) and renal functionality (creatinin \< 2 mg/dl). If there is a lymphoma it's allow values of bilirubin \> 1.5 mg/dl and of creatinin \> 2mg/dl
• • 9. No previous treatment for follicolar lymphoma unless RT-IF
• • 10. Lifetime \> 6 mounth
• • 11. Absence of HbsAg, HCV e HIV
• • 12. Negative Coombs Test
• • 13. Negative pregnant test
• • 14. Cotracceptive method during the treatment and the follow three months
• • 15. Formal written consent
• • 16. Ability to follow the patients after the treatment for follow up
• Exclusion Criteria:
• • 1. Histological Diagnosis of all type of lymphoma unless Follicularlymphoma, CD20 lymphoma, stage IIIb of follicular lymphoma and high degree lymphoma
• • 2. Stage I of Ann Arbor scale
• • 3. Central Nervous system involvement
• • 4. HIV, HBV OR HCV Positivity
• • 5. Cardiac Pathology
• • 6. Positive Coombs Test
• • 7. Previous chemotherapeutic treatment
• • 8. Hypersensitivity to antibodyes or other murine proteins
• • 9. Previous cancer pathology unless in situ cervix and epithelial carcinomas
• • 10. Other type of infections
• • 11. Pregnant and nursing woman