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Follicular LymphomaPhase 3NCT00774826

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

A Phase 3 study testing R-CVP, R-CHOP and R-FM in people with Follicular Lymphoma, run by Fondazione Italiana Linfomi - ETS at 82 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Follicular Lymphoma
What is being tested?
R-CVP, R-CHOP and R-FM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
534 participants
Where
82 sitesItaly
Study dates
Dec 2005to Mar 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 27Show fewer
  • 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
  • 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

Who cannot join

  • Histological Diagnosis of all type of lymphoma unless Follicularlymphoma, CD20 lymphoma, stage IIIb of follicular lymphoma and high degree lymphoma
  • Stage I of Ann Arbor scale
  • Central Nervous system involvement
  • HIV, HBV OR HCV Positivity
  • Cardiac Pathology
  • Positive Coombs Test
Show all 11Show fewer
  • Previous chemotherapeutic treatment
  • Hypersensitivity to antibodyes or other murine proteins
  • Previous cancer pathology unless in situ cervix and epithelial carcinomas
  • Other type of infections
  • Pregnant and nursing woman

Trial locations and contacts

82 sites in 1 country.

82 sites in 1 country

Italy82 sites

  • Ente ecclesiastico Ospedale generale regionale Miulli

    Acquaviva Delle Fonti (BA)

  • Az.Ospedaliera SS.Antonio, Biagio e Cesare Arrigo-U.O.A.Ematologia

    Alessandria

  • Presidio Ospedaliero C.Massaia di Asti

    Asti

  • Istituto Nazionale Tumori

    Aviano

  • IRCCS Istituto tumori Giovanni Paolo II

    Bari

  • Divisione Medicina B Ospedale degli Infermi

    Biella

  • Policlinico Sant'Orsola - Istituto di Ematologia e Oncologia medica L.e A. Seragnoli

    Bologna

  • Ospedale di Bolzano Divisione di Ematologia e Centro Trapianti di Midollo Osseo

    Bolzano

  • A.O.Spedali civili di Brescia

    Brescia

  • Presidio Ospedaliero A.Perrino

    Brindisi

  • Ospedale Businco, Divisione di Ematologia

    Cagliari

  • Ospedale Civile

    Camposanpiero (PD)

  • Istituto per la ricerca e la cura del cancro

    Candiolo (TO)

  • Ospedale Ramazzini Day Hospital Oncologico

    Carpi (Mo)

  • A.O. dell'Annunziata Unita' Operativa di Ematologia

    Carpi (MO)

  • Ospedale Garibaldi-Nesima

    Catania

  • Universita' degli studi di Catania

    Catania

  • A.O. Pugliese A. Ciaccio

    Catanzaro

  • A.O.Pugliese Ciaccio Diviisone di Ematologia

    Catanzaro

  • Ospedale civico di Chivasso

    Chivasso (TO)

  • Ospedale di Ciriè U.O.N.A. Oncologia servizio di Ematologia

    Ciriè (TO)

  • Ospedale civile Divisione di Ematologia

    Civitanova Marche (MC)

  • Ospedale San Sebastiano

    Correggio (RE)

  • Presidio Ospedaliero Annunziata

    Cosenza

  • Azienda istituti ospedalieri di Cremona

    Cremona

  • Policlinico Careggi, cattedra e diviisone di Ematologia

    Florence

  • E.O.Ospedali Galliera U.O.Ematologia

    Genova

  • Ospedale San Martino - Divisione di Ematologia

    Genova

  • Ospedale Felettino reparto di Oncologia

    La Spezia

  • Ospedale Vito Fazzi

    Lecce

  • Ospedale A.Manzoni Oncologia medica

    Lecco

  • Ospedale Madonna delle grazie U.O. Ematologia

    Matera

  • Azienda Ospedaliera Papardo

    Messina

  • Policlinico universitario U.O. Ematologia

    Messina

  • Azienda Ospedaliera Fatebenefratelli e Oftalmico

    Milan

  • IRCCS San Raffaele Unità di Chemioterapia

    Milan

  • Osp. San Carlo Borromeo Divisione di Oncologia Medica

    Milan

  • Ospedale Maggiore IRCCS-Dipartimento di Ematologia

    Milan

  • Ospedale Niguarda CA' Granda

    Milan

  • Ospedale San Paolo U.O. Oncologia Medica

    Milan

  • Policlinico di Modena - Università degli studi

    Modena

  • Ospedale S. Gerardo Divisione di ematologia

    Monza (MI)

  • AORN Cardarelli U.O.Ematologia

    Naples

  • Ospedale P.F.Calvi dipartimento id Oncologia ed Ematologia

    Noale

  • Presidio Ospedaliero Umberto I Medicina ed Onco-Ematologia

    Nocera Inferiore

  • A.O. Maggiore della Carità S.C.D.U. Ematologia

    Novara

  • A.O. di Padova Divisione di Oncologia Medica

    Padova

  • Casa di cura La Maddalena Unita' di Ematologia

    Palermo

  • Policlinico P.Giaccone

    Palermo

  • Universita' degli studi di Parma

    Parma

  • Policlinico San Matteo - Medicina generale

    Pavia

  • Policlinico San Matteo

    Pavia

  • Policlinico Monteluce Divisione di Ematologia

    Perugia

  • Ospedale Santo Spirito Dipartimento di Ematologia

    Pescara

  • Ospedale Santo Spirito-Dipartimento di Oncologia

    Pescara

  • Ospedale Civile, Sezione di Ematologia

    Piacenza

  • Ospedale S. Chiara Azienda ospedaliera pisana

    Pisa

  • Presidio Ospedali riuniti "Bianchi, Melacrino, Morelli" Divisione di ematologia

    Reggio Calabria

  • Azienda ospedaliera Arcispedale S.Maria Nuova

    Reggio Emilia

  • Ospedale Oncologico regionale CROB

    Rionero in Vulture (PZ)

  • A.O.S.Andrea Reparto di Ematologia e Immunoematologia

    Roma

  • Azienda Policlinico Umberto I - La Sapienza

    Roma

  • Istituto Regina Elena

    Roma

  • Ospedale San Giacomo U.O. Ematologia

    Roma

  • Policlinico A. Gemelli Università Cattolica del Sacro Cuore

    Roma

  • Policlinico Universitario Campus biomedico

    Roma

  • Policlinico Universitario Tor Vergata

    Roma

  • Universita' La Sapienza

    Roma

  • P.O. Roncilgione U.O. Ematologia

    Ronciglione (VT)

  • Istituto clinco Humanitas

    Rozzano (MI)

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo (FG)

  • Istituto di Ematologia Università degli studi di Sassari

    Sassari

  • Ospedale civile DH oncologico

    Sassuolo (MO)

  • Ospedale San Paolo

    Savona

  • A.O. della Valtellina e della Valchiavenna Presidio Ospedaliero di Sondalo

    Sondalo

  • Azienda Ospedaliera S. Maria

    Terni, Terni

  • Ospedale S. Maria Clinica Medica Servizio Oncologico

    Terni

  • A.O.San Giovanni Battista

    Torino

  • A.O.Cardinale Panico Ematologia e centro trapianti

    Tricase (LE)

  • Azienda Ospedaliera Ospedali riuniti di Trieste

    Trieste

  • Ospedale di circolo e Fondazione Macchi

    Varese

  • O.C.SS. Giovanni e Paolo - U.O. Ematologia

    Venezia

Other trials in Italy

About this study

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.

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.

Being tested
R-CVP, R-CHOP, R-FM
Keywords
Follicular lymphoma, Rituximab
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-CVPDrug

    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-CHOPDrug

    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-FMDrug

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

Study groups in NCT00774826
Study groupRoleWhat they receive
1ExperimentalR-CVP x 3; Restaging if> RP then R-CVP x 5
Receives: Drug: R-CVP
2ExperimentalR-CHOP x 3; Restaging if > RP then R-CHOP x 3 plus 2 Rituximab
Receives: Drug: R-CHOP
3ExperimentalR-FM x 3; Restaging if > RP then R-FM x 3 plus 2 Rituximab
Receives: Drug: R-FM

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2 years

Secondary outcomes (6)

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

    Measured: 3 years

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

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2008 (estimated)
  2. Study startDec 2005
  3. Primary completionSep 2010
  4. Study completionMar 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
534 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00774826
Sponsor's protocol ID
IIL-FOLL05
Other IDs
Eudract Number 2005-005406-24
Status last verified
Feb 2011
First submitted
14 Oct 2008
Last updated
15 Feb 2011
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing R-CVP, R-CHOP and R-FM in people with Follicular Lymphoma, run by Fondazione Italiana Linfomi - ETS at 82 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00774826, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2011.

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