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

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to define an improvement and theassessment of the Time to Treatment Failure in patients randomized in three different arms:

R-CVP vs R-CHOP vs R-FM.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Italiana Linfomi ONLUS
• Treatments: Rituximab

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