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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fondazione Italiana Linfomi ONLUS
International Follicular Lymphoma Prognostic Factor Project
Information provided by (Responsible Party):
Associazione Angela Serra per la ricerca sul cancro
ClinicalTrials.gov Identifier:
NCT01250223
First received: November 26, 2010
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition
Lymphoma, Follicular

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: F2-PROTOCOL: Prospective Collection of Data of Possible Prognostic Relevance in Patients With Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by Associazione Angela Serra per la ricerca sul cancro:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: 5-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 5-year ] [ Designated as safety issue: No ]
  • Event Free Survival (EFS) [ Time Frame: 5-year ] [ Designated as safety issue: No ]
  • Treatment Free Survival [ Time Frame: 5-year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Formalin-fixed tissue for central diagnostic pathology review


Enrollment: 1093
Study Start Date: February 2003
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250223

  Show 51 Study Locations
Sponsors and Collaborators
Associazione Angela Serra per la ricerca sul cancro
Fondazione Italiana Linfomi ONLUS
International Follicular 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
  More Information

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.

Responsible Party: Associazione Angela Serra per la ricerca sul cancro
ClinicalTrials.gov Identifier: NCT01250223     History of Changes
Other Study ID Numbers: F2-study
Study First Received: November 26, 2010
Last Updated: May 21, 2014
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Associazione Angela Serra per la ricerca sul cancro:
Lymphoma, Follicular
Prognosis
Progression-Free Survival
Outcome
International Cooperation
Data Collection
Prospective studies
Rare Diseases

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014