Status:
UNKNOWN
Multicentric Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Patients With Stage II-IV Follicular Lymphoma
Lead Sponsor:
Fondazione Italiana Linfomi - ETS
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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.
Detailed Description
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 Res...
Eligibility Criteria
Inclusion
- Histological DIAGNOSIS of B cell follicular lymphoma
- ECOG performance status 0-2
- Age range 18-75
- Ann Arbor Stage: II-IV
- Assessment of pathology with diagnostics biopsy
- 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
- LVEF \> 50%
- 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
- No previous treatment for follicolar lymphoma unless RT-IF
- Lifetime \> 6 mounth
- Absence of HbsAg, HCV e HIV
- Negative Coombs Test
- Negative pregnant test
- Cotracceptive method during the treatment and the follow three months
- Formal written consent
- Ability to follow the patients after the treatment for follow up
Exclusion
- Histological Diagnosis of all type of lymphoma unless Follicularlymphoma, CD20 lymphoma, stage IIIb of follicular lymphoma and high degree lymphoma
- Stage I of Ann Arbor scale
- Central Nervous system involvement
- HIV, HBV OR HCV Positivity
- Cardiac Pathology
- Positive Coombs Test
- Previous chemotherapeutic treatment
- Hypersensitivity to antibodyes or other murine proteins
- Previous cancer pathology unless in situ cervix and epithelial carcinomas
- Other type of infections
- Pregnant and nursing woman
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT00774826
Start Date
December 1 2005
End Date
March 1 2014
Last Update
February 15 2011
Active Locations (82)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliera S. Maria
Terni, Terni, Italy
2
Ente ecclesiastico Ospedale generale regionale Miulli
Acquaviva Delle Fonti (BA), Italy
3
Az.Ospedaliera SS.Antonio, Biagio e Cesare Arrigo-U.O.A.Ematologia
Alessandria, Italy
4
Presidio Ospedaliero C.Massaia di Asti
Asti, Italy