Phase III multicentric IIL study, three randomized arms (R-CVP vs R-CHOP vs R-FM),for treatment of patients with stage II-IV follicular lymphoma
- Conditions
- Stage II-IV Follicular LymphomaMedDRA version: 14.1Level: PTClassification code 10016897Term: Follicle centre lymphoma diffuse small cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2005-005406-24-IT
- Lead Sponsor
- FONDAZIONE ITALIANA LINFOMI ONLUS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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: a)B Sistemic symptoms B b)extranodale pathology c)cytopenia d)splenomegaly e)leukemia f)SEROUS EFFUSION g)ves>20 mm/h h)ldh >normal value i)nodale or extranodal mass > 7 cm j)3 or more nodal sites >3 cm k)adenopatic syndrome 7.LVEF> 50% 8.Normal hepatic (bilirubin <1.5 mg/dl) and renal functionality (creatinin < 2mg/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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Histological Diagnosis of all type of lymphoma unless Follicular lymphoma, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM.;Secondary Objective: - 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.;Primary end point(s): to assesment survival, toxicity , clinical and molecolar responses after one cycle of patients treatment
- Secondary Outcome Measures
Name Time Method