Multicentric Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Patients With Stage II-IV Follicular Lymphoma
NCT ID: NCT00774826
Last Updated: 2011-02-15
Study Results
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Basic Information
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UNKNOWN
PHASE3
534 participants
INTERVENTIONAL
2005-12-31
2014-03-31
Brief Summary
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R-CVP vs R-CHOP vs R-FM.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
R-CVP x 3; Restaging if\> RP then R-CVP x 5
R-CVP
Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1, Vincristina: 1,4 mg/mq day 1 Prednisone: 40 mg/mq day 1-5,
2
R-CHOP x 3; Restaging if \> RP then R-CHOP x 3 plus 2 Rituximab
R-CHOP
Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1 Doxorubicina: 50 mg/mq day 1 Vincristina: 1.4 mg/mq day 1 Prednisone: 100 mg/mq day 1-5
3
R-FM x 3; Restaging if \> RP then R-FM x 3 plus 2 Rituximab
R-FM
Rituximab: 375 mg/mq day 1, Fludarabina: 25 mg/mq day 1-3, Mitoxantrone: 10 mg/mq day 1,
Interventions
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R-CVP
Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1, Vincristina: 1,4 mg/mq day 1 Prednisone: 40 mg/mq day 1-5,
R-CHOP
Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1 Doxorubicina: 50 mg/mq day 1 Vincristina: 1.4 mg/mq day 1 Prednisone: 100 mg/mq day 1-5
R-FM
Rituximab: 375 mg/mq day 1, Fludarabina: 25 mg/mq day 1-3, Mitoxantrone: 10 mg/mq day 1,
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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AZIENDA OSPEDALIERA POLICLINICO - MODENA (MO)
Principal Investigators
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Massimo Federico, PhD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria di Modena
Locations
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Azienda Ospedaliera S. Maria
Terni, Terni, 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
Florence, , 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
Milan, , Italy
IRCCS San Raffaele Unità di Chemioterapia
Milan, , Italy
Osp. San Carlo Borromeo Divisione di Oncologia Medica
Milan, , Italy
Ospedale Maggiore IRCCS-Dipartimento di Ematologia
Milan, , Italy
Ospedale Niguarda CA' Granda
Milan, , Italy
Ospedale San Paolo U.O. Oncologia Medica
Milan, , 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
Padua, , 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 - Medicina generale
Pavia, , Italy
Policlinico San Matteo
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
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, , Italy
Countries
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References
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Luminari S, Ferrari A, Manni M, Dondi A, Chiarenza A, Merli F, Rusconi C, Tarantino V, Tucci A, Vitolo U, Kovalchuk S, Angelucci E, Pulsoni A, Arcaini L, Angrilli F, Gaidano G, Stelitano C, Bertoldero G, Cascavilla N, Salvi F, Ferreri AJM, Vallisa D, Marcheselli L, Federico M. Long-Term Results of the FOLL05 Trial Comparing R-CVP Versus R-CHOP Versus R-FM for the Initial Treatment of Patients With Advanced-Stage Symptomatic Follicular Lymphoma. J Clin Oncol. 2018 Mar 1;36(7):689-696. doi: 10.1200/JCO.2017.74.1652. Epub 2017 Nov 2.
Rossi D, Bruscaggin A, La Cava P, Galimberti S, Ciabatti E, Luminari S, Rigacci L, Tucci A, Pulsoni A, Bertoldero G, Vallisa D, Rusconi C, Spina M, Arcaini L, Angrilli F, Stelitano C, Merli F, Gaidano G, Federico M, Palumbo GA. The genotype of MLH1 identifies a subgroup of follicular lymphoma patients who do not benefit from doxorubicin: FIL-FOLL study. Haematologica. 2015 Apr;100(4):517-24. doi: 10.3324/haematol.2014.108183. Epub 2015 Jan 16.
Other Identifiers
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Eudract Number 2005-005406-24
Identifier Type: -
Identifier Source: secondary_id
IIL-FOLL05
Identifier Type: -
Identifier Source: org_study_id
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