Follicular Lymphoma Clinical Trial
Official title:
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
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.
| Status | Active, not recruiting |
| Enrollment | 534 |
| Est. completion date | March 2014 |
| Est. primary completion date | September 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Ente ecclesiastico Ospedale generale regionale Miulli | Acquaviva delle fonti (BA) | |
| Italy | Az.Ospedaliera SS.Antonio, Biagio e Cesare Arrigo-U.O.A.Ematologia | Alessandria | |
| Italy | Presidio Ospedaliero C.Massaia di Asti | Asti | |
| Italy | Istituto Nazionale Tumori | Aviano | |
| Italy | IRCCS Istituto tumori Giovanni Paolo II | Bari | |
| Italy | Divisione Medicina B Ospedale degli Infermi | Biella | |
| Italy | Policlinico Sant'Orsola - Istituto di Ematologia e Oncologia medica L.e A. Seragnoli | Bologna | |
| Italy | Ospedale di Bolzano Divisione di Ematologia e Centro Trapianti di Midollo Osseo | Bolzano | |
| Italy | A.O.Spedali civili di Brescia | Brescia | |
| Italy | Presidio Ospedaliero A.Perrino | Brindisi | |
| Italy | Ospedale Businco, Divisione di Ematologia | Cagliari | |
| Italy | Ospedale Civile | Camposanpiero (PD) | |
| Italy | Istituto per la ricerca e la cura del cancro | Candiolo (TO) | |
| Italy | A.O. dell'Annunziata Unita' Operativa di Ematologia | Carpi (MO) | |
| Italy | Ospedale Ramazzini Day Hospital Oncologico | Carpi (Mo) | |
| Italy | Ospedale Garibaldi-Nesima | Catania | |
| Italy | Universita' degli studi di Catania | Catania | |
| Italy | A.O. Pugliese A. Ciaccio | Catanzaro | |
| Italy | A.O.Pugliese Ciaccio Diviisone di Ematologia | Catanzaro | |
| Italy | Ospedale civico di Chivasso | Chivasso (TO) | |
| Italy | Ospedale di Ciriè U.O.N.A. Oncologia servizio di Ematologia | Ciriè (TO) | |
| Italy | Ospedale civile Divisione di Ematologia | Civitanova Marche (MC) | |
| Italy | Ospedale San Sebastiano | Correggio (RE) | |
| Italy | Presidio Ospedaliero Annunziata | Cosenza | |
| Italy | Azienda istituti ospedalieri di Cremona | Cremona | |
| Italy | Policlinico Careggi, cattedra e diviisone di Ematologia | Firenze | |
| Italy | E.O.Ospedali Galliera U.O.Ematologia | Genova | |
| Italy | Ospedale San Martino - Divisione di Ematologia | Genova | |
| Italy | Ospedale Felettino reparto di Oncologia | La Spezia | |
| Italy | Ospedale Vito Fazzi | Lecce | |
| Italy | Ospedale A.Manzoni Oncologia medica | Lecco | |
| Italy | Ospedale Madonna delle grazie U.O. Ematologia | Matera | |
| Italy | Azienda Ospedaliera Papardo | Messina | |
| Italy | Policlinico universitario U.O. Ematologia | Messina | |
| Italy | Azienda Ospedaliera Fatebenefratelli e Oftalmico | Milano | |
| Italy | IRCCS San Raffaele Unità di Chemioterapia | Milano | |
| Italy | Osp. San Carlo Borromeo Divisione di Oncologia Medica | Milano | |
| Italy | Ospedale Maggiore IRCCS-Dipartimento di Ematologia | Milano | |
| Italy | Ospedale Niguarda CA' Granda | Milano | |
| Italy | Ospedale San Paolo U.O. Oncologia Medica | Milano | |
| Italy | Policlinico di Modena - Università degli studi | Modena | |
| Italy | Ospedale S. Gerardo Divisione di ematologia | Monza (MI) | |
| Italy | AORN Cardarelli U.O.Ematologia | Napoli | |
| Italy | Ospedale P.F.Calvi dipartimento id Oncologia ed Ematologia | Noale | |
| Italy | Presidio Ospedaliero Umberto I Medicina ed Onco-Ematologia | Nocera Inferiore | |
| Italy | A.O. Maggiore della Carità S.C.D.U. Ematologia | Novara | |
| Italy | A.O. di Padova Divisione di Oncologia Medica | Padova | |
| Italy | Casa di cura La Maddalena Unita' di Ematologia | Palermo | |
| Italy | Policlinico P.Giaccone | Palermo | |
| Italy | Universita' degli studi di Parma | Parma | |
| Italy | Policlinico San Matteo | Pavia | |
| Italy | Policlinico San Matteo - Medicina generale | Pavia | |
| Italy | Policlinico Monteluce Divisione di Ematologia | Perugia | |
| Italy | Ospedale Santo Spirito Dipartimento di Ematologia | Pescara | |
| Italy | Ospedale Santo Spirito-Dipartimento di Oncologia | Pescara | |
| Italy | Ospedale Civile, Sezione di Ematologia | Piacenza | |
| Italy | Ospedale S. Chiara Azienda ospedaliera pisana | Pisa | |
| Italy | Presidio Ospedali riuniti "Bianchi, Melacrino, Morelli" Divisione di ematologia | Reggio Calabria | |
| Italy | Azienda ospedaliera Arcispedale S.Maria Nuova | Reggio Emilia | |
| Italy | Ospedale Oncologico regionale CROB | Rionero in Vulture (PZ) | |
| Italy | A.O.S.Andrea Reparto di Ematologia e Immunoematologia | Roma | |
| Italy | Azienda Policlinico Umberto I - La Sapienza | Roma | |
| Italy | Istituto Regina Elena | Roma | |
| Italy | Ospedale San Giacomo U.O. Ematologia | Roma | |
| Italy | Policlinico A. Gemelli Università Cattolica del Sacro Cuore | Roma | |
| Italy | Policlinico Universitario Campus biomedico | Roma | |
| Italy | Policlinico Universitario Tor Vergata | Roma | |
| Italy | Universita' La Sapienza | Roma | |
| Italy | P.O. Roncilgione U.O. Ematologia | Ronciglione (VT) | |
| Italy | Istituto clinco Humanitas | Rozzano (MI) | |
| Italy | IRCCS Casa Sollievo della Sofferenza | San Giovanni Rotondo (FG) | |
| Italy | Istituto di Ematologia Università degli studi di Sassari | Sassari | |
| Italy | Ospedale civile DH oncologico | Sassuolo (MO) | |
| Italy | Ospedale San Paolo | Savona | |
| Italy | A.O. della Valtellina e della Valchiavenna Presidio Ospedaliero di Sondalo | Sondalo | |
| Italy | Azienda Ospedaliera S. Maria | Terni | |
| Italy | Ospedale S. Maria Clinica Medica Servizio Oncologico | Terni | |
| Italy | A.O.San Giovanni Battista | Torino | |
| Italy | A.O.Cardinale Panico Ematologia e centro trapianti | Tricase (LE) | |
| Italy | Azienda Ospedaliera Ospedali riuniti di Trieste | Trieste | |
| Italy | Ospedale di circolo e Fondazione Macchi | Varese | |
| Italy | O.C.SS. Giovanni e Paolo - U.O. Ematologia | Venezia |
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione Italiana Linfomi ONLUS |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM. | 2 years | Yes | |
| Secondary | Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. - | 3 years | Yes | |
| Secondary | Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP | 2 years | Yes | |
| Secondary | Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM. | 2 years | Yes | |
| Secondary | Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM. | 2 years | Yes | |
| Secondary | Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM. | 2 years | Yes | |
| Secondary | Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments. | 2 years | Yes |
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