Study of Prognosis of Follicular Lymphoma Through a Prospective Collection of Data (F2-study)
NCT ID: NCT01250223
Last Updated: 2020-07-09
Study Results
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Basic Information
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COMPLETED
1093 participants
OBSERVATIONAL
2003-02-28
2016-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients with histologically confirmed diagnosis of follicular lymphoma according to WHO classification (any grade)
* Age over 18
* Written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
The International Non-Hodgkin Lymphoma Prognostic Factor Project
OTHER
Associazione Angela Serra per la ricerca sul cancro
OTHER
Responsible Party
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Principal Investigators
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Massimo Federico, MD
Role: STUDY_CHAIR
Dip. Oncologia, Ematologia e Patologie dell'Apparato Respiratorio - Università di Modena e Reggio Emilia, Modena, Italy
Philippe Solal-Céligny, MD
Role: STUDY_CHAIR
Centre Jean Bernard, Le Mans, France
Armando Lopez-Guillermo, MD
Role: STUDY_CHAIR
Institut d'Hematologia i Oncologia, Hospital Clinic, Barcelona, Spain
Peter McLaughlin, MD
Role: STUDY_CHAIR
UT MD Anderson Cancer Ctr, Houston, TX, USA
Umberto Vitolo, MD
Role: STUDY_CHAIR
Azienda Universitaria Ospedaliera San Giovanni Battista, Torino, Italy
Stefano A. Pileri, MD
Role: STUDY_CHAIR
Instituto Seragnoli, Unità Operativa di Emolinfopatologia, Università di Bologna, Bologna, Italy
Locations
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Northwestern University Feinberg School of Medicine - Department of Hematology/Oncology
Chicago, Illinois, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
MD Anderson Cancer Center
Houston, Texas, United States
Academia Nacional de Medicina - Oncohematology Department, Instituto de Investigaciones Hematologicas
Buenos Aires, , Argentina
Centro de Internacion e Investigacion Clinica "Angelica Ocampo" - Hematologia
Buenos Aires, , Argentina
Charles University General Hospital - Ist Dept Medicine
Prague, , Czechia
Centre Hospitalier Universitaire - Hématologie
Besançon, , France
Institut Bergonié Comprehensive Cancer Center
Bordeaux, , France
Centre Jean Bernard, Clinique Victor Hugo
Le Mans, , France
Centre Hospitalier Univeristaire - Hématologie clinique
Nantes, , France
Hopital caremeau - Service de Medecine Interne B
Nîmes, , France
CHRU Bretonneau - Oncologie medicale
Tours, , France
Presidio Spedali Civili
Brescia, BS, Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, CN, Italy
Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino
Catania, CT, Italy
Azienda Ospedaliera Pugliese-Ciaccio
Catanzaro, CZ, Italy
Ospedale Casa Sollievo della Sofferenza IRCCS
San Giovanni Rotondo, FG, Italy
Ospedale unico Versilia USL 12 - Divisione di Medicina II, DH Oncoematologico
Lido di Camaiore, Lucca, Italy
Ospedale San Vincenzo - Ematologia e Immunologia
Taormina, Messina, Italy
Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
Messina, ME, Italy
Istituto Clinico Humanitas
Milan, MI, Italy
Istituto Scientifico Universitario San Raffaele
Milan, MI, Italy
Istituto Europeo di Oncologia
Milan, MI, Italy
Ospedale Madonna delle Grazie
Matera, Mount, Italy
Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Ematologia
Modena, MO, Italy
Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Medicina Interna
Modena, MO, Italy
Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Oncologia II
Modena, MO, Italy
Casa di Cura La Maddalena
Palermo, Pa, Italy
Ospedale civile Guglielmo da Saliceto - Medicina Oncologica ed Ematologica
Piacenza, PC, Italy
Ospedale Santo Spirito, USL di Pescara - Dipartimento di Oncologia
Pescara, PE, Italy
Policlinico Monteluce - Divisione di Clinica Medica
Perugia, PG, Italy
Azienda Ospedaliera Universitaria Pisana - UO di Ematologia
Pisa, PI, Italy
Fondazione IRCCS Policlinico San Matteo - Clinica Ematologica
Pavia, PV, Italy
Azienda Ospedaliera S. Carlo - Oncologia Medica
Potenza, PZ, Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria, RC, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, RE, Italy
Ospedale E. Morelli - Divisione di Medicina Generale, Ematologia
Sondalo, Sondrio, Italy
Azienda Ospedaliera Universitaria San Giovanni Battista
Torino, TO, Italy
Policlinico Universitario a gestione diretta - Divisione di Ematologia
Udine, UD, Italy
Ospedale Civile SS. Giovanni e Paolo - UO di Ematologia
Venezia, VE, Italy
Azienda Ospedaliera Maggiore della Carità
Novara, , Italy
Azienda Ospedaliera Sant'Andrea - UOC Ematologia
Roma, , Italy
Ospedale Sant'Eugenio - Ematologia
Roma, , Italy
Università la Sapienza, Dip. di Biotecnologie Cellulari ed Ematologia, Sez. Ematologia
Roma, , Italy
Hospital Universitari Germans Trias i Pujol - Institut Català d'Oncologia
Badalona, , Spain
Hospital Clinic - Institut d'Hematologia i Oncologia
Barcelona, , Spain
Hospital Universitario Vall de Hebron - Servei d'Hematologia Clinica
Barcelona, , Spain
Institu Catala d'Oncologia - Servei d'Hematologia
Girona, , Spain
Hospital Clinico Universitario
Valencia, , Spain
Ospedale S. Giovanni
Bellinzona, Canton Ticino, Switzerland
Barths and The London NHS Trust
London, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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F2-study
Identifier Type: -
Identifier Source: org_study_id
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