Clinical trial NCT02904577: Indolent Non Follicular Lymphomas Prognostic Project
Official title: Indolent Non Follicular Lymphomas Prognostic Project - Prospective Collection of Data of Possible Prognostic Relevance in Patients with Indolent Non-follicular B-CELL Lymphomas
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Indolent B-Cell Lymphomas
Keywords: Indolent B-Cell Lymphomas
prospective collection
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed diagnosis of non-follicular low grade B-cell lymphoma.

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival for the treated cohort
timeFrame: September 2024 (13 years)
Secondary outcomes:
measure: Progression-free survival for the untreated cohort
timeFrame: September 2024 (13 years)
measure: Overall survival
timeFrame: September 2024 (13 years)
measure: Event-free survival
timeFrame: September 2024 (13 years)
measure: Remission rate with initial therapy
timeFrame: September 2017 (Six years)
measure: Epidemiology
timeFrame: September 2016 (Five years)
measure: Time dependent analysis for patients in Watch & Wait policy.
timeFrame: September 2024 (13 years)
measure: Remission rates with second and subsequent lines of therapy
timeFrame: September 2024 (13 years)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Univ Med Int I
city: Campinas
country: Brazil
facility: Center of Hematology and Hemotherapy, UNICAMP, University of Campinas
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal Do Rio de Janeiro
city: São Paulo
country: Brazil
facility: São Paulo-Santa Casa Medical School
city: Paris
country: France
facility: Hospital Saint-Louis
city: Pagani
country: Italy
facility: UO Oncoematologia Ospedale Umberto I
state: Salerno
city: Aviano (PN)
country: Italy
facility: Oncologia Medica A - Centro di Riferimento Oncologico
city: Bari
country: Italy
facility: UO Ematologia con Trapianto Policlinico Consorziale
city: Bergamo
country: Italy
facility: USC Ematologia Ospedali Riuniti di Bergamo
city: Cagliari
country: Italy
facility: Ematologia e CTMO Ospedale Businco
city: Catania
country: Italy
facility: UOC Ematologia, Azienda Ospedaliera Garibaldi P.O. Nesima
city: Como
country: Italy
facility: US Oncoematologia- Ospedale Valduce
city: Cosenza
country: Italy
facility: Unità Operativa Complessa di Ematologia - AO di Cosenza
city: Lecce
country: Italy
facility: UO Ematologia, PO Vito Fazzi
city: Matera
country: Italy
facility: Ematologia Ospedale Madonna delle Grazie
city: Messina
country: Italy
facility: SC. Ematologia. Osp. Riuniti Papardo Piemonte
city: Milano
country: Italy
facility: Dipartimento di Oncoematologia Ospedale San Raffaele
city: Milano
country: Italy
facility: SC Ematologia AO Niguarda Ca' Granda
city: Milano
country: Italy
facility: UO Ematologia, AO San Carlo Borromeo
city: Milano
country: Italy
facility: UO Oncologia Medica, Ospedale San Paolo
city: Milano
country: Italy
facility: UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
city: Modena
country: Italy
facility: Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia
city: Monza
country: Italy
facility: Clinica Ematologica AO San Gerardo di Monza
city: Novara
country: Italy
facility: SCDU Ematologia - AOU Ospedale Maggiore
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Parma
country: Italy
facility: Ematologia e CTMO Ospedale Maggiore di Parma
city: Pavia
country: Italy
facility: Ematologia IRCCS Policlinico S. Matteo di Pavia
city: Pescara
country: Italy
facility: Dipartimento di Ematologia Ospedale Civile Spirito Santo Pescara
city: Pisa
country: Italy
facility: UO Ematologia AOU S. Chiara Pisa
city: Reggio Calabria
country: Italy
facility: Divisione di Ematologia - Azienda Ospedaliera Bianchi Melacrino Morelli
city: Reggio Emilia
country: Italy
facility: SC Ematologia Arcispedale Santa Maria Nuova
city: Rionero in Vulture
country: Italy
facility: UO Ematologia e Trapianto Cellule Staminali, IRCCS, Centro di riferimento Oncologico di Basilicata
city: Roma
country: Italy
facility: Ematologia Università Campus Biomedico
city: Roma
country: Italy
facility: Ematologia Università Roma La Sapienza
city: Roma
country: Italy
facility: UOSD DH Ematologia Ospedale San Eugenio
city: Rozzano (MI)
country: Italy
facility: Dipartimento di Oncologia Medica ed Ematologia Istituto Humanitas
city: Sassuolo
country: Italy
facility: UOC Medicina Interna MO DH Oncologico
city: Siena
country: Italy
facility: UOC Ematologia, AOU Senese
city: Taranto
country: Italy
facility: Ematologia PO SG Moscati
city: Terni
country: Italy
facility: SC Oncoematologia con autotrapianto AO S. Maria Terni
city: Torino
country: Italy
facility: SC Ematologia Universitaria, AO Città della Salute e della Scienza
city: Torino
country: Italy
facility: SC Ematologia, AO Città della Salute e della Scienza
city: Varese
country: Italy
facility: Unità operativa Complessa Ematologia - Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
city: Vicenza
country: Italy
facility: Divisione di Ematologia, Ospedale San Bortolo
city: Lisboa
country: Portugal
facility: LISBOA-IPO "Francisco Gentil"
city: Kiev
country: Ukraine
facility: National Cancer Institute of Health Ukraine
Study officials:
affiliation: Divisione di Ematologia IRCCS Policlinico S. Matteo Pavia
name: Arcaini Luca, MD
role: STUDY_CHAIR
References:
citation: 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.