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Status unknownNCT00774826Updated Feb 15, 2011

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

A Phase 3 interventional study of R-CVP and R-CHOP in Follicular Lymphoma, sponsored by Fondazione Italiana Linfomi - ETS. Status unknown at 82 sites in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-02-15.

Sponsored by Fondazione Italiana Linfomi - ETS · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2011), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
534
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Follicular Lymphoma

Keywords

  • Follicular lymphoma
  • Rituximab
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 534 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Fondazione Italiana Linfomi - ETS is the lead sponsor of 89 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
534 participants (actual)

Study arms

  • Experimental
    1

    R-CVP x 3; Restaging if\> RP then R-CVP x 5

    Drug: R-CVP

  • Experimental
    2

    R-CHOP x 3; Restaging if \> RP then R-CHOP x 3 plus 2 Rituximab

    Drug: R-CHOP

  • Experimental
    3

    R-FM x 3; Restaging if \> RP then R-FM x 3 plus 2 Rituximab

    Drug: R-FM

Interventions

  • DrugR-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,

  • DrugR-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

  • DrugR-FM

    Rituximab: 375 mg/mq day 1, Fludarabina: 25 mg/mq day 1-3, Mitoxantrone: 10 mg/mq day 1,

06

What researchers measure

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

  1. Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -

    Time frame: 3 years

  2. Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP

    Time frame: 2 years

  3. Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM.

    Time frame: 2 years

  4. Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM.

    Time frame: 2 years

  5. Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM.

    Time frame: 2 years

  6. Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.

    Time frame: 2 years

07

Study locations

82 sites
  • 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 - 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
  • 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, Italy
08

References and documents

Publications

  • 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. PubMed 29095677 ↗
  • 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. PubMed 25596266 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00774826
Lead sponsor
Fondazione Italiana Linfomi - ETS
First posted
Oct 17, 2008
Start date
Dec 2005
Primary completion
Sep 2010
Completion
Mar 2014 (estimated)
Last update
Feb 15, 2011

Study contacts

Massimo Federico, PhD
principal investigator · Azienda Ospedaliero-Universitaria di Modena

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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