Indolent Non Follicular Lymphomas Prognostic Project

NCT ID: NCT02904577

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

370 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2024-12-31

Brief Summary

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Prospective collection of data of possible prognostic relevance in patients with indolent non - follicular B-CELL Lymphomas.

Detailed Description

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The present study is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed patients with non-follicular low grade B-cell lymphoma.

The study is aimed to verify whether a prognostic collection of data would allow the development of a more accurate prognostic assessment for non-follicular low grade B-cell lymphomas.

Conditions

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Indolent B-Cell Lymphomas

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Training and validation cohort

One cohort: from this cohort 2/3 of patients will be randomly separated after registration in training sample, to develop a prognostic model, and 1/3 in test sample, to validate the prognostic score obtained from the prognostic model.

The training cohort aims to develop a prognostic model and a resulting score, on the basis of clinical, biochemical and blood count parameters, in patients with non-follicular indolent lymphomas.

Intervention: any treatment, watch and wait policy included

The validation cohort is aims to assess the prognostic score on a collected set of data in parallel but independently of the "sample training".

Intervention: any treatment, watch and wait policy included

Any treatment, watch and wait policy included

Intervention Type OTHER

Patients registered in the study despite their planned treatment, watch and wait policy included. The "planned treatment" mentioned in the protocol is just the ideal approach proposed by investigators.The treatment can change depending on the evolution of the disease, without this affects the study's purposes.

Interventions

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Any treatment, watch and wait policy included

Patients registered in the study despite their planned treatment, watch and wait policy included. The "planned treatment" mentioned in the protocol is just the ideal approach proposed by investigators.The treatment can change depending on the evolution of the disease, without this affects the study's purposes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients with histologically confirmed diagnosis of non-follicular low grade B-cell lymphoma

* Splenic MZL (bone marrow histology and/or spleen tissue)
* Extranodal MZL of MALT (tissue biopsy)
* Nodal MZL (lymph node biopsy)
* Lymphocytic lymphoma (lymph node biopsy)
* Lymphoplasmacytic lymphoma (bone marrow histology or lymph node biopsy)
* CD5-negative low grade B-cell lymphoma (bone marrow histology)
2. Age over 18
3. Written informed consent

Exclusion Criteria

1\. None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arcaini Luca, MD

Role: STUDY_CHAIR

Divisione di Ematologia IRCCS Policlinico S. Matteo Pavia

Locations

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Vienna Univ Med Int I

Vienna, , Austria

Site Status

Center of Hematology and Hemotherapy, UNICAMP, University of Campinas

Campinas, , Brazil

Site Status

Universidade Federal Do Rio de Janeiro

Rio de Janeiro, , Brazil

Site Status

São Paulo-Santa Casa Medical School

São Paulo, , Brazil

Site Status

Hospital Saint-Louis

Paris, , France

Site Status

UO Oncoematologia Ospedale Umberto I

Pagani, Salerno, Italy

Site Status

Oncologia Medica A - Centro di Riferimento Oncologico

Aviano (PN), , Italy

Site Status

UO Ematologia con Trapianto Policlinico Consorziale

Bari, , Italy

Site Status

USC Ematologia Ospedali Riuniti di Bergamo

Bergamo, , Italy

Site Status

Ematologia e CTMO Ospedale Businco

Cagliari, , Italy

Site Status

UOC Ematologia, Azienda Ospedaliera Garibaldi P.O. Nesima

Catania, , Italy

Site Status

US Oncoematologia- Ospedale Valduce

Como, , Italy

Site Status

Unità Operativa Complessa di Ematologia - AO di Cosenza

Cosenza, , Italy

Site Status

UO Ematologia, PO Vito Fazzi

Lecce, , Italy

Site Status

Ematologia Ospedale Madonna delle Grazie

Matera, , Italy

Site Status

SC. Ematologia. Osp. Riuniti Papardo Piemonte

Messina, , Italy

Site Status

Dipartimento di Oncoematologia Ospedale San Raffaele

Milan, , Italy

Site Status

SC Ematologia AO Niguarda Ca' Granda

Milan, , Italy

Site Status

UO Ematologia, AO San Carlo Borromeo

Milan, , Italy

Site Status

UO Oncologia Medica, Ospedale San Paolo

Milan, , Italy

Site Status

UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia

Modena, , Italy

Site Status

Clinica Ematologica AO San Gerardo di Monza

Monza, , Italy

Site Status

SCDU Ematologia - AOU Ospedale Maggiore

Novara, , Italy

Site Status

Istituto Oncologico Veneto IRCCS

Padua, , Italy

Site Status

Ematologia e CTMO Ospedale Maggiore di Parma

Parma, , Italy

Site Status

Ematologia IRCCS Policlinico S. Matteo di Pavia

Pavia, , Italy

Site Status

Dipartimento di Ematologia Ospedale Civile Spirito Santo Pescara

Pescara, , Italy

Site Status

UO Ematologia AOU S. Chiara Pisa

Pisa, , Italy

Site Status

Divisione di Ematologia - Azienda Ospedaliera Bianchi Melacrino Morelli

Reggio Calabria, , Italy

Site Status

SC Ematologia Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Site Status

UO Ematologia e Trapianto Cellule Staminali, IRCCS, Centro di riferimento Oncologico di Basilicata

Rionero in Vulture, , Italy

Site Status

Ematologia Università Campus Biomedico

Roma, , Italy

Site Status

Ematologia Università Roma La Sapienza

Roma, , Italy

Site Status

UOSD DH Ematologia Ospedale San Eugenio

Roma, , Italy

Site Status

Dipartimento di Oncologia Medica ed Ematologia Istituto Humanitas

Rozzano (MI), , Italy

Site Status

UOC Medicina Interna MO DH Oncologico

Sassuolo, , Italy

Site Status

UOC Ematologia, AOU Senese

Siena, , Italy

Site Status

Ematologia PO SG Moscati

Taranto, , Italy

Site Status

SC Oncoematologia con autotrapianto AO S. Maria Terni

Terni, , Italy

Site Status

SC Ematologia Universitaria, AO Città della Salute e della Scienza

Torino, , Italy

Site Status

SC Ematologia, AO Città della Salute e della Scienza

Torino, , Italy

Site Status

Unità operativa Complessa Ematologia - Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Site Status

Divisione di Ematologia, Ospedale San Bortolo

Vicenza, , Italy

Site Status

LISBOA-IPO "Francisco Gentil"

Lisbon, , Portugal

Site Status

National Cancer Institute of Health Ukraine

Kiev, , Ukraine

Site Status

Countries

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Austria Brazil France Italy Portugal Ukraine

References

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Luminari S, Merli M, Rattotti S, Tarantino V, Marcheselli L, Cavallo F, Varettoni M, Bianchi B, Merli F, Tedeschi A, Cabras G, Re F, Visco C, Torresan Delamain M, Cencini E, Spina M, Ferrero S, Ferrari A, Deodato M, Mannina D, Annibali O, Rago A, Orsucci L, Defrancesco I, Frigeni M, Cesaretti M, Arcaini L. Early progression as a predictor of survival in marginal zone lymphomas: an analysis from the FIL-NF10 study. Blood. 2019 Sep 5;134(10):798-801. doi: 10.1182/blood.2019001088. Epub 2019 Jul 10.

Reference Type DERIVED
PMID: 31292118 (View on PubMed)

Other Identifiers

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NF2010

Identifier Type: -

Identifier Source: org_study_id

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