Indolent Non Follicular Lymphomas Prognostic Project

Indolent B-Cell Lymphomas Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02904577
• Other study ID #: NF2010
• Status: Active, not recruiting
• Start date: September 2011
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Fondazione Italiana Linfomi - ETS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 370
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Indolent B-Cell Lymphomas
• Lymphoma
• Lymphoma, B-Cell

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Austria	Vienna Univ Med Int I	Vienna
Brazil	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
France	Hospital Saint-Louis	Paris
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	Milano
Italy	SC Ematologia AO Niguarda Ca' Granda	Milano
Italy	UO Ematologia, AO San Carlo Borromeo	Milano
Italy	UO Oncologia Medica, Ospedale San Paolo	Milano
Italy	UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano
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	Padova
Italy	UO Oncoematologia Ospedale Umberto I	Pagani	Salerno
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
Portugal	LISBOA-IPO "Francisco Gentil"	Lisboa
Ukraine	National Cancer Institute of Health Ukraine	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi - ETS

Countries where clinical trial is conducted

Austria,  Brazil,  France,  Italy,  Portugal,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free survival for the untreated 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	Overall survival	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.	September 2024 (13 years)
Secondary	Event-free survival	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.	September 2024 (13 years)
Secondary	Remission rate with initial therapy	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.	September 2017 (Six years)
Secondary	Epidemiology	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).	September 2016 (Five years)
Secondary	Time dependent analysis for patients in Watch & Wait policy.	In WW group the start of treatment will be treated as a time-varying covariate in Cox proportional hazard regression.	September 2024 (13 years)
Secondary	Remission rates with second and subsequent lines of therapy	Remission rate (RR) is defined as the number of CR and PR after the second and subsequent lines of therapy, due to progression disease.	September 2024 (13 years)