Indolent Non Follicular Lymphomas Prognostic Project
- Conditions
- Indolent B-Cell Lymphomas
- Interventions
- Other: Any treatment, watch and wait policy included
- Registration Number
- NCT02904577
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 370
-
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
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Training and validation cohort Any treatment, watch and wait policy included 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
- Primary Outcome Measures
Name Time Method Progression-free survival for the treated cohort September 2024 (13 years) 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.
- Secondary Outcome Measures
Name Time Method Progression-free survival for the untreated cohort September 2024 (13 years) 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.
Overall survival September 2024 (13 years) Overall survival (OS) is defined as the time from the study entry until the date of death irrespective of cause. Patients who have not died at the time of end of the whole study , and patients who are lost to follow up , will be censored at the date of the last contact.
Event-free survival September 2024 (13 years) Event Free Survival (EFS) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression) or death from any cause.
Time dependent analysis for patients in Watch & Wait policy. September 2024 (13 years) In WW group the start of treatment will be treated as a time-varying covariate in Cox proportional hazard regression.
Remission rate with initial therapy September 2017 (Six years) Remission rate (RR) is defined as the number of complete and partial remission (CR and PR) after the completion of the first line of treatment.
Epidemiology September 2016 (Five years) Will be collected the risk factors potentially associated to the outcome of indolent non follicular lymphomas (clinical status, biochemistry, hemochrome, HCV, HBV and autoimmnity markers). Will be collected the risk factors potentially associated to the outcome of indolent non follicular lymphoma (clinical status, biochemistry, hemochrome, HCV, HBV and autoimmunity markers). Those risk factors will be utilized to obtain a prognostic model (prognostic index) from the Cox proportional hazard regression and, finally, a prognostic score grouping the prognostic index in at least three group of risk (low, intermediate, high risk).
Remission rates with second and subsequent lines of therapy September 2024 (13 years) Remission rate (RR) is defined as the number of CR and PR after the second and subsequent lines of therapy, due to progression disease.
Trial Locations
- Locations (46)
UO Oncoematologia Ospedale Umberto I
🇮🇹Pagani, Salerno, Italy
US Oncoematologia- Ospedale Valduce
🇮🇹Como, Italy
Ematologia Ospedale Madonna delle Grazie
🇮🇹Matera, Italy
Vienna Univ Med Int I
🇦🇹Vienna, Austria
Oncologia Medica A - Centro di Riferimento Oncologico
🇮🇹Aviano (PN), Italy
UO Ematologia con Trapianto Policlinico Consorziale
🇮🇹Bari, Italy
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
SC. Ematologia. Osp. Riuniti Papardo Piemonte
🇮🇹Messina, Italy
UO Ematologia, AO San Carlo Borromeo
🇮🇹Milano, Italy
UOC Ematologia 1/CTMO, Fondazione IRCCS CÃ Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Ematologia IRCCS Policlinico S. Matteo di Pavia
🇮🇹Pavia, Italy
UOC Ematologia, AOU Senese
🇮🇹Siena, Italy
Hospital Saint-Louis
🇫🇷Paris, France
USC Ematologia Ospedali Riuniti di Bergamo
🇮🇹Bergamo, Italy
Ematologia e CTMO Ospedale Businco
🇮🇹Cagliari, Italy
Ematologia e CTMO Ospedale Maggiore di Parma
🇮🇹Parma, Italy
Divisione di Ematologia, Ospedale San Bortolo
🇮🇹Vicenza, Italy
Ematologia Università Roma La Sapienza
🇮🇹Roma, Italy
UOC Ematologia, Azienda Ospedaliera Garibaldi P.O. Nesima
🇮🇹Catania, Italy
UO Ematologia, PO Vito Fazzi
🇮🇹Lecce, Italy
Dipartimento di Oncoematologia Ospedale San Raffaele
🇮🇹Milano, Italy
Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia
🇮🇹Modena, Italy
SCDU Ematologia - AOU Ospedale Maggiore
🇮🇹Novara, Italy
UOC Medicina Interna MO DH Oncologico
🇮🇹Sassuolo, Italy
Ematologia PO SG Moscati
🇮🇹Taranto, Italy
SC Ematologia Universitaria, AO Città della Salute e della Scienza
🇮🇹Torino, Italy
SC Ematologia, AO Città della Salute e della Scienza
🇮🇹Torino, Italy
LISBOA-IPO "Francisco Gentil"
🇵🇹Lisboa, Portugal
Ematologia Università Campus Biomedico
🇮🇹Roma, Italy
Unità Operativa Complessa di Ematologia - AO di Cosenza
🇮🇹Cosenza, Italy
Clinica Ematologica AO San Gerardo di Monza
🇮🇹Monza, Italy
Dipartimento di Ematologia Ospedale Civile Spirito Santo Pescara
🇮🇹Pescara, Italy
Dipartimento di Oncologia Medica ed Ematologia Istituto Humanitas
🇮🇹Rozzano (MI), Italy
National Cancer Institute of Health Ukraine
🇺🇦Kiev, Ukraine
UOSD DH Ematologia Ospedale San Eugenio
🇮🇹Roma, Italy
SC Ematologia AO Niguarda Ca' Granda
🇮🇹Milano, Italy
UO Oncologia Medica, Ospedale San Paolo
🇮🇹Milano, Italy
Istituto Oncologico Veneto IRCCS
🇮🇹Padova, 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
SC Oncoematologia con autotrapianto AO S. Maria Terni
🇮🇹Terni, Italy
Unità operativa Complessa Ematologia - Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy