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

Lymphoma, Follicular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250223
• Other study ID #: F2-study
• Status: Completed
• Start date: February 2003
• Est. completion date: December 2016

Study information

• Verified date: July 2020
• Source: Associazione Angela Serra per la ricerca sul cancro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1093
• Est. completion date: December 2016
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Locations

Country	Name	City	State
Argentina	Academia Nacional de Medicina - Oncohematology Department, Instituto de Investigaciones Hematologicas	Buenos Aires
Argentina	Centro de Internacion e Investigacion Clinica "Angelica Ocampo" - Hematologia	Buenos Aires
Czechia	Charles University General Hospital - Ist Dept Medicine	Praha
France	Centre Hospitalier Universitaire - Hématologie	Besancon
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	Nimes
France	CHRU Bretonneau - Oncologie medicale	Tours
Italy	Presidio Spedali Civili	Brescia	BS
Italy	Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino	Catania	CT
Italy	Azienda Ospedaliera Pugliese-Ciaccio	Catanzaro	CZ
Italy	Azienda Ospedaliera S. Croce e Carle	Cuneo	CN
Italy	Ospedale unico Versilia USL 12 - Divisione di Medicina II, DH Oncoematologico	Lido di Camaiore	Lucca
Italy	Ospedale Madonna delle Grazie	Matera	Mount
Italy	Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte	Messina	ME
Italy	Istituto Clinico Humanitas	Milano	MI
Italy	Istituto Europeo di Oncologia	Milano	MI
Italy	Istituto Scientifico Universitario San Raffaele	Milano	MI
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	Azienda Ospedaliera Maggiore della Carità	Novara
Italy	Casa di Cura La Maddalena	Palermo	Pa
Italy	Fondazione IRCCS Policlinico San Matteo - Clinica Ematologica	Pavia	PV
Italy	Policlinico Monteluce - Divisione di Clinica Medica	Perugia	PG
Italy	Ospedale Santo Spirito, USL di Pescara - Dipartimento di Oncologia	Pescara	PE
Italy	Ospedale civile Guglielmo da Saliceto - Medicina Oncologica ed Ematologica	Piacenza	PC
Italy	Azienda Ospedaliera Universitaria Pisana - UO di Ematologia	Pisa	PI
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	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	Ospedale Casa Sollievo della Sofferenza IRCCS	San Giovanni Rotondo	FG
Italy	Ospedale E. Morelli - Divisione di Medicina Generale, Ematologia	Sondalo	Sondrio
Italy	Ospedale San Vincenzo - Ematologia e Immunologia	Taormina	Messina
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
Spain	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
Switzerland	Ospedale S. Giovanni	Bellinzona	TI
United Kingdom	Barths and The London NHS Trust	London
United States	Northwestern University Feinberg School of Medicine - Department of Hematology/Oncology	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (3)

Lead Sponsor	Collaborator
Associazione Angela Serra per la ricerca sul cancro	Fondazione Italiana Linfomi ONLUS, The International Non-Hodgkin Lymphoma Prognostic Factor Project

Countries where clinical trial is conducted

United States,  Argentina,  Czechia,  France,  Italy,  Spain,  Switzerland,  United Kingdom, 

References & Publications (4)

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 (IFL

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-Céligny P. Follic — View Citation

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

Solal-Céligny 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)		5-year
Secondary	Overall Survival (OS)		5-year
Secondary	Event Free Survival (EFS)		5-year
Secondary	Treatment Free Survival		5-year