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

Phase 3

• Conditions: Follicular Lymphoma
• Interventions: Drug: R-CVP; Drug: R-CHOP; Drug: R-FM

• Registration Number: NCT00774826
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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 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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-17
• Primary Completion: 2010-09
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-14
• Last Update Posted: 2011-02-15
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 534

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	R-CVP	R-CVP x 3; Restaging if\> RP then R-CVP x 5
2	R-CHOP	R-CHOP x 3; Restaging if \> RP then R-CHOP x 3 plus 2 Rituximab
3	R-FM	R-FM x 3; Restaging if \> RP then R-FM x 3 plus 2 Rituximab

Primary Outcome Measures

Name	Time	Method
Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM.	2 years

Secondary Outcome Measures

Name	Time	Method
Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -	3 years
Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP	2 years
Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM.	2 years
Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM.	2 years
Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM.	2 years
Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.	2 years

Trial Locations

Locations (82)

Osp. San Carlo Borromeo Divisione di Oncologia Medica; 🇮🇹 Milano, Italy

Ospedale Niguarda CA' Granda; 🇮🇹 Milano, Italy

AORN Cardarelli U.O.Ematologia; 🇮🇹 Napoli, Italy

Presidio Ospedaliero Umberto I Medicina ed Onco-Ematologia; 🇮🇹 Nocera Inferiore, Italy

Policlinico P.Giaccone; 🇮🇹 Palermo, Italy

Presidio Ospedali riuniti "Bianchi, Melacrino, Morelli" Divisione di ematologia; 🇮🇹 Reggio Calabria, Italy

Ospedale S. Maria Clinica Medica Servizio Oncologico; 🇮🇹 Terni, Italy

A.O.San Giovanni Battista; 🇮🇹 Torino, Italy

Az.Ospedaliera SS.Antonio, Biagio e Cesare Arrigo-U.O.A.Ematologia; 🇮🇹 Alessandria, Italy

Istituto Nazionale Tumori; 🇮🇹 Aviano, Italy

Policlinico Sant'Orsola - Istituto di Ematologia e Oncologia medica L.e A. Seragnoli; 🇮🇹 Bologna, Italy

Ospedale Businco, Divisione di Ematologia; 🇮🇹 Cagliari, Italy

Presidio Ospedaliero C.Massaia di Asti; 🇮🇹 Asti, Italy

Ospedale Ramazzini Day Hospital Oncologico; 🇮🇹 Carpi (Mo), Italy

Ospedale civico di Chivasso; 🇮🇹 Chivasso (TO), Italy

Ospedale Felettino reparto di Oncologia; 🇮🇹 La Spezia, Italy

Ospedale A.Manzoni Oncologia medica; 🇮🇹 Lecco, Italy

Policlinico di Modena - Università degli studi; 🇮🇹 Modena, Italy

Ospedale P.F.Calvi dipartimento id Oncologia ed Ematologia; 🇮🇹 Noale, Italy

A.O. di Padova Divisione di Oncologia Medica; 🇮🇹 Padova, Italy

Policlinico San Matteo; 🇮🇹 Pavia, Italy

Ente ecclesiastico Ospedale generale regionale Miulli; 🇮🇹 Acquaviva delle fonti (BA), Italy

Divisione Medicina B Ospedale degli Infermi; 🇮🇹 Biella, Italy

IRCCS Istituto tumori Giovanni Paolo II; 🇮🇹 Bari, Italy

A.O.Spedali civili di Brescia; 🇮🇹 Brescia, Italy

Presidio Ospedaliero A.Perrino; 🇮🇹 Brindisi, 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 Garibaldi-Nesima; 🇮🇹 Catania, Italy

Universita' degli studi di Catania; 🇮🇹 Catania, Italy

A.O. Pugliese A. Ciaccio; 🇮🇹 Catanzaro, Italy

Ospedale di Ciriè U.O.N.A. Oncologia servizio di Ematologia; 🇮🇹 Ciriè (TO), Italy

Ospedale San Sebastiano; 🇮🇹 Correggio (RE), Italy

Ospedale civile Divisione di Ematologia; 🇮🇹 Civitanova Marche (MC), Italy

Azienda istituti ospedalieri di Cremona; 🇮🇹 Cremona, Italy

Policlinico Careggi, cattedra e diviisone di Ematologia; 🇮🇹 Firenze, Italy

Ospedale San Martino - Divisione di Ematologia; 🇮🇹 Genova, Italy

Ospedale Maggiore IRCCS-Dipartimento di Ematologia; 🇮🇹 Milano, Italy

A.O. Maggiore della Carità S.C.D.U. Ematologia; 🇮🇹 Novara, Italy

Presidio Ospedaliero Annunziata; 🇮🇹 Cosenza, Italy

Ospedale Madonna delle grazie U.O. Ematologia; 🇮🇹 Matera, Italy

Azienda Ospedaliera Papardo; 🇮🇹 Messina, Italy

Ospedale San Paolo U.O. Oncologia Medica; 🇮🇹 Milano, Italy

Policlinico Monteluce Divisione di Ematologia; 🇮🇹 Perugia, Italy

Ospedale Oncologico regionale CROB; 🇮🇹 Rionero in Vulture (PZ), Italy

E.O.Ospedali Galliera U.O.Ematologia; 🇮🇹 Genova, Italy

Ospedale Vito Fazzi; 🇮🇹 Lecce, Italy

Policlinico universitario U.O. Ematologia; 🇮🇹 Messina, Italy

Azienda Ospedaliera Fatebenefratelli e Oftalmico; 🇮🇹 Milano, Italy

IRCCS San Raffaele Unità di Chemioterapia; 🇮🇹 Milano, Italy

Ospedale S. Gerardo Divisione di ematologia; 🇮🇹 Monza (MI), Italy

Casa di cura La Maddalena Unita' di Ematologia; 🇮🇹 Palermo, Italy

Universita' degli studi di Parma; 🇮🇹 Parma, Italy

Policlinico San Matteo - Medicina generale; 🇮🇹 Pavia, Italy

Ospedale Santo Spirito-Dipartimento di Oncologia; 🇮🇹 Pescara, Italy

Ospedale Santo Spirito Dipartimento di Ematologia; 🇮🇹 Pescara, Italy

Ospedale S. Chiara Azienda ospedaliera pisana; 🇮🇹 Pisa, Italy

A.O.S.Andrea Reparto di Ematologia e Immunoematologia; 🇮🇹 Roma, Italy

Istituto Regina Elena; 🇮🇹 Roma, Italy

Ospedale San Giacomo U.O. Ematologia; 🇮🇹 Roma, Italy

Universita' La Sapienza; 🇮🇹 Roma, Italy

IRCCS Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo (FG), Italy

Policlinico A. Gemelli Università Cattolica del Sacro Cuore; 🇮🇹 Roma, Italy

Policlinico Universitario Campus biomedico; 🇮🇹 Roma, Italy

P.O. Roncilgione U.O. Ematologia; 🇮🇹 Ronciglione (VT), Italy

Policlinico Universitario Tor Vergata; 🇮🇹 Roma, Italy

Istituto clinco Humanitas; 🇮🇹 Rozzano (MI), Italy

Istituto di Ematologia Università degli studi di Sassari; 🇮🇹 Sassari, Italy

Ospedale San Paolo; 🇮🇹 Savona, Italy

Azienda Ospedaliera S. Maria; 🇮🇹 Terni, Italy

O.C.SS. Giovanni e Paolo - U.O. Ematologia; 🇮🇹 Venezia, Italy

A.O.Cardinale Panico Ematologia e centro trapianti; 🇮🇹 Tricase (LE), Italy

Azienda Policlinico Umberto I - La Sapienza; 🇮🇹 Roma, Italy

Ospedale di Bolzano Divisione di Ematologia e Centro Trapianti di Midollo Osseo; 🇮🇹 Bolzano, Italy

A.O.Pugliese Ciaccio Diviisone di Ematologia; 🇮🇹 Catanzaro, Italy

Azienda ospedaliera Arcispedale S.Maria Nuova; 🇮🇹 Reggio Emilia, Italy

Ospedale Civile, Sezione di Ematologia; 🇮🇹 Piacenza, Italy

Azienda Ospedaliera Ospedali riuniti di Trieste; 🇮🇹 Trieste, Italy

Ospedale di circolo e Fondazione Macchi; 🇮🇹 Varese, Italy

Ospedale civile DH oncologico; 🇮🇹 Sassuolo (MO), Italy

A.O. della Valtellina e della Valchiavenna Presidio Ospedaliero di Sondalo; 🇮🇹 Sondalo, Italy