Stage II-IV Follicular Lymphoma MedDRA version: 14.1 Level: PT Classification code 10016897 Term: Follicle centre lymphoma diffuse small cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration number: 375-
Trade Name: VINCRISTIN
Sponsors
FONDAZIONE ITALIANA LINFOMI ONLUS
Eligibility
Sex/Gender
All
Inclusion 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: 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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed