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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract Number 2005-005406-24 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | R-CVP x 3; Restaging if> RP then R-CVP x 5 |
|
| 2 | Experimental | R-CHOP x 3; Restaging if > RP then R-CHOP x 3 plus 2 Rituximab |
|
| 3 | Experimental | R-FM x 3; Restaging if > RP then R-FM x 3 plus 2 Rituximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-CVP | Drug | 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, |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
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:
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 Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Federico, PhD | Azienda Ospedaliero-Universitaria di Modena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera S. Maria | Terni | Terni | Italy | |||
| Ente ecclesiastico Ospedale generale regionale Miulli |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29095677 | Derived | 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. | |
| 25596266 |
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| R-CHOP | Drug | 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 | Drug | Rituximab: 375 mg/mq day 1, Fludarabina: 25 mg/mq day 1-3, Mitoxantrone: 10 mg/mq day 1, |
|
| 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 |
| 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 | Naples | 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 - 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 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C571759 | R-CHOP protocol |
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