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

July 7, 2020 updated by: Associazione Angela Serra per la ricerca sul cancro

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1093

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Academia Nacional de Medicina - Oncohematology Department, Instituto de Investigaciones Hematologicas
      • Buenos Aires, Argentina
        • Centro de Internacion e Investigacion Clinica "Angelica Ocampo" - Hematologia
  • Czechia
      • Praha, Czechia
        • Charles University General Hospital - Ist Dept Medicine
  • France
      • Besancon, France
        • Centre Hospitalier Universitaire - Hématologie
      • Bordeaux, France
        • Institut Bergonié Comprehensive Cancer Center
      • Le Mans, France
        • Centre Jean Bernard, Clinique Victor Hugo
      • Nantes, France
        • Centre Hospitalier Univeristaire - Hématologie clinique
      • Nimes, France
        • Hopital caremeau - Service de Medecine Interne B
      • Tours, France
        • CHRU Bretonneau - Oncologie medicale
  • Italy
      • Novara, Italy, 28100
        • Azienda Ospedaliera Maggiore Della Carita
      • Roma, 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
    • BS
      • Brescia, BS, Italy, 25123
        • Presidio Spedali Civili
    • CN
      • Cuneo, CN, Italy, 12100
        • Azienda Ospedaliera S. Croce e Carle
    • CT
      • Catania, CT, Italy, 95124
        • Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • Azienda Ospedaliera Pugliese-Ciaccio
    • FG
      • San Giovanni Rotondo, FG, Italy, 71013
        • Ospedale Casa Sollievo Della Sofferenza IRCCS
    • Lucca
      • Lido di Camaiore, Lucca, Italy
        • Ospedale unico Versilia USL 12 - Divisione di Medicina II, DH Oncoematologico
    • ME
      • Messina, ME, Italy, 98158
        • Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
    • MI
      • Milano, MI, Italy, 20089
        • Istituto Clinico Humanitas
      • Milano, MI, Italy, 20132
        • Istituto scientifico universitario San Raffaele
      • Milano, MI, Italy, 20142
        • Istituto Europeo di Oncologia
    • MO
      • Modena, MO, Italy, 41100
        • Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Ematologia
      • Modena, MO, Italy, 41100
        • Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Medicina Interna
      • Modena, MO, Italy, 41100
        • Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Oncologia II
    • Messina
      • Taormina, Messina, Italy
        • Ospedale San Vincenzo - Ematologia e Immunologia
    • Mount
      • Matera, Mount, Italy, 75100
        • Ospedale Madonna delle Grazie
    • PC
      • Piacenza, PC, Italy
        • Ospedale civile Guglielmo da Saliceto - Medicina Oncologica ed Ematologica
    • PE
      • Pescara, PE, Italy
        • Ospedale Santo Spirito, USL di Pescara - Dipartimento di Oncologia
    • PG
      • Perugia, PG, Italy
        • Policlinico Monteluce - Divisione di Clinica Medica
    • PI
      • Pisa, PI, Italy
        • Azienda Ospedaliera Universitaria Pisana - UO di Ematologia
    • PV
      • Pavia, PV, Italy
        • Fondazione IRCCS Policlinico San Matteo - Clinica Ematologica
    • PZ
      • Potenza, PZ, Italy
        • Azienda Ospedaliera S. Carlo - Oncologia Medica
    • Pa
      • Palermo, Pa, Italy, 90100
        • Casa di Cura La Maddalena
    • RC
      • Reggio Calabria, RC, Italy, 89100
        • Azienda Ospedaliera Bianchi-Melacrino-Morelli
    • RE
      • Reggio Emilia, RE, Italy, 42100
        • Arcispedale S. Maria Nuova
    • Sondrio
      • Sondalo, Sondrio, Italy
        • Ospedale E. Morelli - Divisione di Medicina Generale, Ematologia
    • TO
      • Torino, TO, Italy, 10126
        • Azienda Ospedaliera Universitaria San Giovanni Battista
    • UD
      • Udine, UD, Italy
        • Policlinico Universitario a gestione diretta - Divisione di Ematologia
    • VE
      • Venezia, VE, Italy
        • Ospedale Civile SS. Giovanni e Paolo - UO di Ematologia
  • Spain
      • Badalona, Spain
        • Hospital Universitari Germans Trias i Pujol - Institut Català d'Oncologia
      • Barcelona, Spain
        • Hospital Clinic - Institut d'Hematologia i Oncologia
      • Barcelona, Spain
        • Hospital Universitario Vall de Hebron - Servei d'Hematologia Clinica
      • Girona, Spain
        • Institu Catala d'Oncologia - Servei d'Hematologia
      • Valencia, Spain
        • Hospital Clinico Universitario
  • Switzerland
    • TI
      • Bellinzona, TI, Switzerland, 6500
        • Ospedale S. Giovanni
  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Barths and The London NHS Trust
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine - Department of Hematology/Oncology
    • Nebraska
      • Omaha, Nebraska, United States, 68022
        • University of Nebraska Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS)
Time Frame: 5-year
5-year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 5-year
5-year
Event Free Survival (EFS)
Time Frame: 5-year
5-year
Treatment Free Survival
Time Frame: 5-year
5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associazione Angela Serra per la ricerca sul cancro

Collaborators

Fondazione Italiana Linfomi ONLUS
The International Non-Hodgkin Lymphoma Prognostic Factor Project

Investigators

  • Study Chair: Massimo Federico, MD, Dip. Oncologia, Ematologia e Patologie dell'Apparato Respiratorio - Università di Modena e Reggio Emilia, Modena, Italy
  • Study Chair: Philippe Solal-Céligny, MD, Centre Jean Bernard, Le Mans, France
  • Study Chair: Armando Lopez-Guillermo, MD, Institut d'Hematologia i Oncologia, Hospital Clinic, Barcelona, Spain
  • Study Chair: Peter McLaughlin, MD, UT MD Anderson Cancer Ctr, Houston, TX, USA
  • Study Chair: Umberto Vitolo, MD, Azienda Universitaria Ospedaliera San Giovanni Battista, Torino, Italy
  • Study Chair: Stefano A. Pileri, MD, Instituto Seragnoli, Unità Operativa di Emolinfopatologia, Università di Bologna, Bologna, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 26, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F2-study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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