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Lymphoma, FollicularNCT01250223

Study of Prognosis of Follicular Lymphoma Through a Prospective Collection of Data (F2-study)

An observational study of Lymphoma, Follicular, run by Associazione Angela Serra per la ricerca sul cancro at 51 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The F2-study is a complement of the previous studies of the Follicular Lymphoma Prognostic Factors Project which permitted the development of the Follicular Lymphoma International Prognostic Index (FLIPI). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Follicular
How many people
1,093 participants
Where
51 sitesin 8 countries
Study dates
Feb 2003to Dec 2016
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Previously-untreated patients with de novo diagnosis of Follicular Lymphoma according to World Health Organization (WHO) classification (grade 1,2,3a,3b)

Who may be able to join

  • Patients with newly diagnosed follicular lymphoma
  • Patients with histologically confirmed diagnosis of follicular lymphoma according to WHO classification (any grade)
  • Age over 18
  • Written informed consent

Who cannot join

  • None

Trial locations and contacts

51 sites in 8 countries.

51 sites in 8 countries

Italy32 sites

  • Presidio Spedali Civili

    Brescia, BS, 25123

  • Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino

    Catania, CT, 95124

  • Azienda Ospedaliera Pugliese-Ciaccio

    Catanzaro, CZ, 88100

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo, CN, 12100

  • Ospedale unico Versilia USL 12 - Divisione di Medicina II, DH Oncoematologico

    Lido di Camaiore, Lucca

  • Ospedale Madonna delle Grazie

    Matera, Mount, 75100

  • Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

    Messina, ME, 98158

  • Istituto Clinico Humanitas

    Milan, MI, 20089

  • Istituto Scientifico Universitario San Raffaele

    Milan, MI, 20132

  • Istituto Europeo di Oncologia

    Milan, MI, 20142

  • Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Ematologia

    Modena, MO, 41100

  • Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Medicina Interna

    Modena, MO, 41100

  • Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Oncologia II

    Modena, MO, 41100

  • Azienda Ospedaliera Maggiore della Carità

    Novara, 28100

  • Casa di Cura La Maddalena

    Palermo, Pa, 90100

  • Fondazione IRCCS Policlinico San Matteo - Clinica Ematologica

    Pavia, PV

  • Policlinico Monteluce - Divisione di Clinica Medica

    Perugia, PG

  • Ospedale Santo Spirito, USL di Pescara - Dipartimento di Oncologia

    Pescara, PE

  • Ospedale civile Guglielmo da Saliceto - Medicina Oncologica ed Ematologica

    Piacenza, PC

  • Azienda Ospedaliera Universitaria Pisana - UO di Ematologia

    Pisa, PI

  • Azienda Ospedaliera S. Carlo - Oncologia Medica

    Potenza, PZ

  • Azienda Ospedaliera Bianchi-Melacrino-Morelli

    Reggio Calabria, RC, 89100

  • Arcispedale S. Maria Nuova

    Reggio Emilia, RE, 42100

  • Azienda Ospedaliera Sant'Andrea - UOC Ematologia

    Roma

  • Ospedale Sant'Eugenio - Ematologia

    Roma

  • Università la Sapienza, Dip. di Biotecnologie Cellulari ed Ematologia, Sez. Ematologia

    Roma

  • Ospedale Casa Sollievo della Sofferenza IRCCS

    San Giovanni Rotondo, FG, 71013

  • Ospedale E. Morelli - Divisione di Medicina Generale, Ematologia

    Sondalo, Sondrio

  • Ospedale San Vincenzo - Ematologia e Immunologia

    Taormina, Messina

  • Azienda Ospedaliera Universitaria San Giovanni Battista

    Torino, TO, 10126

  • Policlinico Universitario a gestione diretta - Divisione di Ematologia

    Udine, UD

  • Ospedale Civile SS. Giovanni e Paolo - UO di Ematologia

    Venezia, VE

Other trials in Italy

France6 sites

  • Centre Hospitalier Universitaire - Hématologie

    Besançon

  • Institut Bergonié Comprehensive Cancer Center

    Bordeaux

  • Centre Jean Bernard, Clinique Victor Hugo

    Le Mans

  • Centre Hospitalier Univeristaire - Hématologie clinique

    Nantes

  • Hopital caremeau - Service de Medecine Interne B

    Nîmes

  • CHRU Bretonneau - Oncologie medicale

    Tours

Other trials in France

Spain5 sites

  • Hospital Universitari Germans Trias i Pujol - Institut Català d'Oncologia

    Badalona

  • Hospital Clinic - Institut d'Hematologia i Oncologia

    Barcelona

  • Hospital Universitario Vall de Hebron - Servei d'Hematologia Clinica

    Barcelona

  • Institu Catala d'Oncologia - Servei d'Hematologia

    Girona

  • Hospital Clinico Universitario

    Valencia

Other trials in Spain

United States3 sites

  • Northwestern University Feinberg School of Medicine - Department of Hematology/Oncology

    Chicago, Illinois, 60611

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68022

Other trials in United States

Argentina2 sites

  • Academia Nacional de Medicina - Oncohematology Department, Instituto de Investigaciones Hematologicas

    Buenos Aires

  • Centro de Internacion e Investigacion Clinica "Angelica Ocampo" - Hematologia

    Buenos Aires

Other trials in Argentina

Czechia1 site

  • Charles University General Hospital - Ist Dept Medicine

    Prague

Other trials in Czechia

Switzerland1 site

  • Ospedale S. Giovanni

    Bellinzona, Canton Ticino, 6500

Other trials in Switzerland

United Kingdom1 site

  • Barths and The London NHS Trust

    London, EC1A 7BE

Other trials in United Kingdom

About this study

Official title: F2-PROTOCOL: Prospective Collection of Data of Possible Prognostic Relevance in Patients With Follicular Lymphoma

The F2-study is a complement of the previous studies of the Follicular Lymphoma Prognostic Factors Project which permitted the development of the Follicular Lymphoma International Prognostic Index (FLIPI).

The F2-study is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed Follicular Lymphoma patients, and its purposes are to validate the FLIPI and to verify whether a prognostic collection of data would allow the development of a more accurate prognostic index.

Read the detailed description

So far, in patients with lymphoma a variety of studies aimed at the evaluation of prognosis have been conducted. In particular, different demographic, clinical and biological factors have shown a prognostic role in univariate and multivariate analysis, including age, gender, stage, tumor burden, bone marrow involvement, systemic symptoms, Performance status, serum lactate dehydrogenase (LDH) level, anemia, erythrocyte sedimentation rate (ESR) and beta-2 microglobulin.

The combination of those parameters has allowed the identification of several prognostic scores.

Attempts to define prognosis in follicular lymphomas begun in the late '70s. Then, when in 1993 the International Prognostic Index (IPI) was defined for aggressive lymphomas it was also applied to low-grade lymphomas leading to conflicting results, and the need for a prognostic index specifically designed for follicular lymphomas emerged.

A large study on prognosis in patients with follicular lymphoma was performed by the Italian Lymphoma Intergroup that leaded to the definition of the Italian Lymphoma Intergroup (ILI) score, based on 987 patients (Federico M et al. Blood 2000; 95(3):783-789). In 2004 the Follicular Lymphoma International Prognostic Project allowed the definition of a new score on 4167 pts with follicular lymphoma, the Follicular Lymphoma International Prognostic Index (FLIPI) (Solal-Céligny P et al. Blood 2004;104(5):1258-1265). This score is based on the evaluation of age (younger than 60 years vs 60 years or older), Ann Arbor stage (I-II vs III-IV), number of nodal sites (0-4 vs > 5 or more), Hemoglobin (Hb)level (greater than or equal 12g/dL vs lower than 12g/dL), serum Lactate Dehydrogenase (LDH) (normal vs elevated) and identifies three main groups of patients with different survival:low risk (0-1 factors); intermediate risk (2 factors); high risk (3-5 factors).

Notwithstanding the huge number of patients considered in these studies, all mentioned prognostic scores (IPI, ILI and FLIPI) are based on a retrospective analysis of archive data. This approach can introduce biases that can hamper final results. A first problem is the selection of patients that can be influenced by single institution policy and patient's or physician's related factors. Furthermore, some important variables, such as beta2-microglobulin or Erythrocyte Sedimentation Rate (ESR), that have frequently shown a high prognostic significance in univariate analysis, are hardly included in the final indexes because they are available only in a small number of patients thus loosing their value in multivariate analysis. Then, lacking homogeneous and prospectively defined criteria, retrospective evaluation of some study parameter as for example clinical response cannot be easily defined and all derived endpoints such as Failure Free Survival (FFS)or Progression Free Survival (PFS) may be biased.

Finally the results of a retrospective analysis aiming at the evaluation of survival are dependent on the type of administered treatment and with the recent advent of new drugs such as monoclonal antibodies and purine analogs that can be used also in the elderly patients the role of some established prognostic factor may have changed.

These are the reasons why we thought it would be useful to start a new study based on the prospective registration in a short period of time of patients with follicular lymphoma for whom it would be possible collect an exhaustive set of clinical data and biological information.

Keywords
Lymphoma, Follicular, Prognosis, Progression-Free Survival, Outcome, International Cooperation, Data Collection, Prospective studies, Rare Diseases
Medical subject headings
Lymphoma, Follicular, Rare Diseases

What is being measured

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

  1. Progression Free Survival (PFS)

    Measured: 5-year

Secondary outcomes (3)

  1. Overall Survival (OS)

    Measured: 5-year

  2. Event Free Survival (EFS)

    Measured: 5-year

  3. Treatment Free Survival

    Measured: 5-year

Timeline

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

  1. First posted30 Nov 2010 (estimated)
  2. Study startFeb 2003
  3. Primary completionMay 2008
  4. Study completionDec 2016

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,093 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01250223
Sponsor's protocol ID
F2-study
Status last verified
Jul 2020
First submitted
26 Nov 2010
Last updated
9 Jul 2020
Results posted
No
Data monitoring committee
No

Publications

  • Federico M, Bellei M, Pro B, Lopez-Guillermo A, Marcheselli L, Trneny M, Soubeyran P, MCLaughlin P, Pileri S, Solal-Céligny P on behalf of the F2 study. Revalidation of FLIPI in patients with Follicular Lymphoma (FL) registered in the F2 study and treated upfront with immunochemotherapy. J Clin Oncol 25(18s), 2007. Abstr 8008.

  • Federico M, Bellei M, Marcheselli L, Luminari S, Lopez-Guillermo A, Vitolo U, Pro B, Martelli M, Soubeyran P, Cortelazzo S, Martinelli G, Pileri S, McLaughlin P, Solal-Céligny P on behalf of International Follicular Lymphoma Prognostic factor Project (IFLPFP) F2-study group. F2 prognostic index. Ann Oncol 19(suppl 4):101-102, 2008. Abstr 058.

  • Federico M, Bellei M, Marcheselli L, Luminari S, Lopez-Guillermo A, Vitolo U, Pro B, Pileri S, Pulsoni A, Soubeyran P, Cortelazzo S, Martinelli G, Martelli M, Rigacci L, Arcaini L, Di Raimondo F, Merli F, Sabattini E, McLaughlin P, Solal-Celigny P. Follicular lymphoma international prognostic index 2: a new prognostic index for follicular lymphoma developed by the international follicular lymphoma prognostic factor project. J Clin Oncol. 2009 Sep 20;27(27):4555-62. doi: 10.1200/JCO.2008.21.3991. Epub 2009 Aug 3.

    PubMed 19652063

  • Solal-Celigny P, Bellei M, Marcheselli L, Pesce EA, Pileri S, McLaughlin P, Luminari S, Pro B, Montoto S, Ferreri AJ, Deconinck E, Milpied N, Gordon LI, Federico M. Watchful waiting in low-tumor burden follicular lymphoma in the rituximab era: results of an F2-study database. J Clin Oncol. 2012 Nov 1;30(31):3848-53. doi: 10.1200/JCO.2010.33.4474. Epub 2012 Sep 24.

    PubMed 23008294

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphoma, Follicular, run by Associazione Angela Serra per la ricerca sul cancro at 51 sites in 8 countries.

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 4 inclusion and 1 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: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Italy, France, Spain, United States, Argentina and 3 more countries. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression Free Survival (PFS) (time frame: 5-year). 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 NCT01250223, which also lists 4 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 9 Jul 2020.

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