Indolent Non Follicular Lymphomas Prognostic Project
1 other identifier
observational
370
6 countries
46
Brief Summary
Prospective collection of data of possible prognostic relevance in patients with indolent non - follicular B-CELL Lymphomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Longer than P75 for all trials
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 6, 2016
CompletedFirst Posted
Study publicly available on registry
September 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedAugust 8, 2025
December 1, 2024
13.3 years
September 6, 2016
August 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival for the treated cohort
Progression free survival (PFS) will be measured from the date of randomization to the date of documented first occurrence of disease progression or relapse or to the date of death from any cause. Patients who are lost to follow up will be censored at their last assessment date.
September 2024 (13 years)
Secondary Outcomes (7)
Progression-free survival for the untreated cohort
September 2024 (13 years)
Overall survival
September 2024 (13 years)
Event-free survival
September 2024 (13 years)
Remission rate with initial therapy
September 2017 (Six years)
Epidemiology
September 2016 (Five years)
- +2 more secondary outcomes
Study Arms (1)
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
Interventions
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.
Eligibility Criteria
Patients with histologically confirmed diagnosis of non-follicular low grade B-cell lymphoma.
You may qualify if:
- 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)
- Age over 18
- Written informed consent
You may not qualify if:
- \. None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Vienna Univ Med Int I
Vienna, Austria
Center of Hematology and Hemotherapy, UNICAMP, University of Campinas
Campinas, Brazil
Universidade Federal Do Rio de Janeiro
Rio de Janeiro, Brazil
São Paulo-Santa Casa Medical School
São Paulo, Brazil
Hospital Saint-Louis
Paris, France
UO Oncoematologia Ospedale Umberto I
Pagani, Salerno, Italy
Oncologia Medica A - Centro di Riferimento Oncologico
Aviano (PN), Italy
UO Ematologia con Trapianto Policlinico Consorziale
Bari, Italy
USC Ematologia Ospedali Riuniti di Bergamo
Bergamo, Italy
Ematologia e CTMO Ospedale Businco
Cagliari, Italy
UOC Ematologia, Azienda Ospedaliera Garibaldi P.O. Nesima
Catania, Italy
US Oncoematologia- Ospedale Valduce
Como, Italy
Unità Operativa Complessa di Ematologia - AO di Cosenza
Cosenza, Italy
UO Ematologia, PO Vito Fazzi
Lecce, Italy
Ematologia Ospedale Madonna delle Grazie
Matera, Italy
SC. Ematologia. Osp. Riuniti Papardo Piemonte
Messina, Italy
Dipartimento di Oncoematologia Ospedale San Raffaele
Milan, Italy
SC Ematologia AO Niguarda Ca' Granda
Milan, Italy
UO Ematologia, AO San Carlo Borromeo
Milan, Italy
UO Oncologia Medica, Ospedale San Paolo
Milan, Italy
UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia
Modena, Italy
Clinica Ematologica AO San Gerardo di Monza
Monza, Italy
SCDU Ematologia - AOU Ospedale Maggiore
Novara, Italy
Istituto Oncologico Veneto IRCCS
Padua, Italy
Ematologia e CTMO Ospedale Maggiore di Parma
Parma, Italy
Ematologia IRCCS Policlinico S. Matteo di Pavia
Pavia, Italy
Dipartimento di Ematologia Ospedale Civile Spirito Santo Pescara
Pescara, Italy
UO Ematologia AOU S. Chiara Pisa
Pisa, Italy
Divisione di Ematologia - Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, Italy
SC Ematologia Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
UO Ematologia e Trapianto Cellule Staminali, IRCCS, Centro di riferimento Oncologico di Basilicata
Rionero in Vulture, Italy
Ematologia Università Campus Biomedico
Roma, Italy
Ematologia Università Roma La Sapienza
Roma, Italy
UOSD DH Ematologia Ospedale San Eugenio
Roma, Italy
Dipartimento di Oncologia Medica ed Ematologia Istituto Humanitas
Rozzano (MI), Italy
UOC Medicina Interna MO DH Oncologico
Sassuolo, Italy
UOC Ematologia, AOU Senese
Siena, Italy
Ematologia PO SG Moscati
Taranto, Italy
SC Oncoematologia con autotrapianto AO S. Maria Terni
Terni, Italy
SC Ematologia Universitaria, AO Città della Salute e della Scienza
Torino, Italy
SC Ematologia, AO Città della Salute e della Scienza
Torino, Italy
Unità operativa Complessa Ematologia - Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Varese, Italy
Divisione di Ematologia, Ospedale San Bortolo
Vicenza, Italy
LISBOA-IPO "Francisco Gentil"
Lisbon, Portugal
National Cancer Institute of Health Ukraine
Kiev, Ukraine
Related Publications (1)
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.
PMID: 31292118DERIVED
Biospecimen
Central pathological review. The reviewed material will refer to both onset and eventual relapse.
Study Officials
- STUDY CHAIR
Arcaini Luca, MD
Divisione di Ematologia IRCCS Policlinico S. Matteo Pavia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2016
First Posted
September 19, 2016
Study Start
September 1, 2011
Primary Completion
December 1, 2024
Study Completion
December 31, 2024
Last Updated
August 8, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share