Indolent Non Follicular Lymphomas Prognostic Project

Indolent Non Follicular Lymphomas Prognostic Project - Prospective Collection of Data of Possible Prognostic Relevance in Patients With Indolent Non-follicular B-CELL Lymphomas

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

Study Overview

• Status: Active, not recruiting
• Conditions: Indolent B-Cell Lymphomas
• Intervention / Treatment: Other: Any treatment, watch and wait policy included

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.

• Study Type: Observational
• Enrollment (Estimated): 370

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Vienna Univ Med Int I
• Brazil
  • Campinas, Brazil
    • Center of Hematology and Hemotherapy, UNICAMP, University of Campinas
  • Rio de Janeiro, Brazil
    • Universidade Federal do Rio de Janeiro
  • São Paulo, Brazil
    • São Paulo-Santa Casa Medical School
• France
  • Paris, France
    • Hôspital Saint-Louis
• Italy
  • Aviano (PN), Italy
    • Oncologia Medica A - Centro di Riferimento Oncologico
  • Bari, Italy
    • UO Ematologia con Trapianto Policlinico Consorziale
  • Bergamo, Italy
    • USC Ematologia Ospedali Riuniti di Bergamo
  • Cagliari, Italy
    • Ematologia e CTMO Ospedale Businco
  • Catania, Italy
    • UOC Ematologia, Azienda Ospedaliera Garibaldi P.O. Nesima
  • Como, Italy
    • US Oncoematologia- Ospedale Valduce
  • Cosenza, Italy
    • Unità Operativa Complessa di Ematologia - AO di Cosenza
  • Lecce, Italy
    • UO Ematologia, PO Vito Fazzi
  • Matera, Italy
    • Ematologia Ospedale Madonna delle Grazie
  • Messina, Italy
    • SC. Ematologia. Osp. Riuniti Papardo Piemonte
  • Milano, 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
  • Modena, Italy
    • Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia
  • Monza, Italy
    • Clinica Ematologica AO San Gerardo di Monza
  • Novara, Italy
    • SCDU Ematologia - AOU Ospedale Maggiore
  • Padova, Italy
    • Istituto Oncologico Veneto IRCCS
  • Parma, Italy
    • Ematologia e CTMO Ospedale Maggiore di Parma
  • Pavia, Italy
    • Ematologia IRCCS Policlinico S. Matteo di Pavia
  • Pescara, Italy
    • Dipartimento di Ematologia Ospedale Civile Spirito Santo Pescara
  • Pisa, Italy
    • UO Ematologia AOU S. Chiara Pisa
  • Reggio Calabria, Italy
    • Divisione di Ematologia - Azienda Ospedaliera Bianchi Melacrino Morelli
  • Reggio Emilia, Italy
    • SC Ematologia Arcispedale Santa Maria Nuova
  • Rionero in Vulture, Italy
    • UO Ematologia e Trapianto Cellule Staminali, IRCCS, Centro di riferimento Oncologico di Basilicata
  • Roma, Italy
    • Ematologia Università Campus Biomedico
  • Roma, Italy
    • Ematologia Università Roma La Sapienza
  • Roma, Italy
    • UOSD DH Ematologia Ospedale San Eugenio
  • Rozzano (MI), Italy
    • Dipartimento di Oncologia Medica ed Ematologia Istituto Humanitas
  • Sassuolo, Italy
    • UOC Medicina Interna MO DH Oncologico
  • Siena, Italy
    • UOC Ematologia, AOU Senese
  • Taranto, Italy
    • Ematologia PO SG Moscati
  • Terni, Italy
    • SC Oncoematologia con autotrapianto AO S. Maria Terni
  • Torino, Italy
    • SC Ematologia Universitaria, AO Città della Salute e della Scienza
  • Torino, Italy
    • SC Ematologia, AO Città della Salute e della Scienza
  • Varese, Italy
    • Unità operativa Complessa Ematologia - Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
  • Vicenza, Italy
    • Divisione di Ematologia, Ospedale San Bortolo
  • Salerno
    • Pagani, Salerno, Italy
      • UO Oncoematologia Ospedale Umberto I
• Portugal
  • Lisboa, Portugal
    • LISBOA-IPO "Francisco Gentil"
• Ukraine
  • Kiev, Ukraine
    • National Cancer Institute of Health Ukraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Fondazione Italiana Linfomi - ETS
• Investigators: Study Chair: Arcaini Luca, MD, Divisione di Ematologia IRCCS Policlinico S. Matteo Pavia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimated): September 19, 2016

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Indolent B-Cell Lymphomas; prospective collection
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: NF2010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO