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Indolent B-Cell LymphomasNCT02904577

Indolent Non Follicular Lymphomas Prognostic Project

An observational study of Indolent B-Cell Lymphomas, run by Fondazione Italiana Linfomi - ETS at 46 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective collection of data of possible prognostic relevance in patients with indolent non - follicular B-CELL Lymphomas. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Indolent B-Cell Lymphomas
What is being tested?
Any treatment, watch and wait policy included
How many people
370 participants
Where
46 sitesin 6 countries
Study dates
Sep 2011to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)
Show all 9Show fewer
  • CD5-negative low grade B-cell lymphoma (bone marrow histology)
  • Age over 18
  • Written informed consent

Who cannot join

  • 1. None

Trial locations and contacts

46 sites in 6 countries.

46 sites in 6 countries

Italy39 sites

  • Oncologia Medica A - Centro di Riferimento Oncologico

    Aviano (PN)

  • UO Ematologia con Trapianto Policlinico Consorziale

    Bari

  • USC Ematologia Ospedali Riuniti di Bergamo

    Bergamo

  • Ematologia e CTMO Ospedale Businco

    Cagliari

  • UOC Ematologia, Azienda Ospedaliera Garibaldi P.O. Nesima

    Catania

  • US Oncoematologia- Ospedale Valduce

    Como

  • Unità Operativa Complessa di Ematologia - AO di Cosenza

    Cosenza

  • UO Ematologia, PO Vito Fazzi

    Lecce

  • Ematologia Ospedale Madonna delle Grazie

    Matera

  • SC. Ematologia. Osp. Riuniti Papardo Piemonte

    Messina

  • Dipartimento di Oncoematologia Ospedale San Raffaele

    Milan

  • SC Ematologia AO Niguarda Ca' Granda

    Milan

  • UO Ematologia, AO San Carlo Borromeo

    Milan

  • UO Oncologia Medica, Ospedale San Paolo

    Milan

  • UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan

  • Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia

    Modena

  • Clinica Ematologica AO San Gerardo di Monza

    Monza

  • SCDU Ematologia - AOU Ospedale Maggiore

    Novara

  • Istituto Oncologico Veneto IRCCS

    Padova

  • UO Oncoematologia Ospedale Umberto I

    Pagani, Salerno

  • Ematologia e CTMO Ospedale Maggiore di Parma

    Parma

  • Ematologia IRCCS Policlinico S. Matteo di Pavia

    Pavia

  • Dipartimento di Ematologia Ospedale Civile Spirito Santo Pescara

    Pescara

  • UO Ematologia AOU S. Chiara Pisa

    Pisa

  • Divisione di Ematologia - Azienda Ospedaliera Bianchi Melacrino Morelli

    Reggio Calabria

  • SC Ematologia Arcispedale Santa Maria Nuova

    Reggio Emilia

  • UO Ematologia e Trapianto Cellule Staminali, IRCCS, Centro di riferimento Oncologico di Basilicata

    Rionero in Vulture

  • Ematologia Università Campus Biomedico

    Roma

  • Ematologia Università Roma La Sapienza

    Roma

  • UOSD DH Ematologia Ospedale San Eugenio

    Roma

  • Dipartimento di Oncologia Medica ed Ematologia Istituto Humanitas

    Rozzano (MI)

  • UOC Medicina Interna MO DH Oncologico

    Sassuolo

  • UOC Ematologia, AOU Senese

    Siena

  • Ematologia PO SG Moscati

    Taranto

  • SC Oncoematologia con autotrapianto AO S. Maria Terni

    Terni

  • SC Ematologia Universitaria, AO Città della Salute e della Scienza

    Torino

  • SC Ematologia, AO Città della Salute e della Scienza

    Torino

  • Unità operativa Complessa Ematologia - Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi

    Varese

  • Divisione di Ematologia, Ospedale San Bortolo

    Vicenza

Other trials in Italy

Brazil3 sites

  • Center of Hematology and Hemotherapy, UNICAMP, University of Campinas

    Campinas

  • Universidade Federal Do Rio de Janeiro

    Rio de Janeiro

  • São Paulo-Santa Casa Medical School

    São Paulo

Other trials in Brazil

Austria1 site

  • Vienna Univ Med Int I

    Vienna

Other trials in Austria

France1 site

  • Hospital Saint-Louis

    Paris

Other trials in France

Portugal1 site

  • LISBOA-IPO "Francisco Gentil"

    Lisbon

Other trials in Portugal

Ukraine1 site

  • National Cancer Institute of Health Ukraine

    Kiev

Other trials in Ukraine

About this study

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

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

Read the 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.

Being tested
Any treatment, watch and wait policy included
Keywords
Indolent B-Cell Lymphomas, prospective collection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Any treatment, watch and wait policy includedOther

    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.

Study groups in NCT02904577
Study groupRoleWhat they receive
Training and validation cohortOne 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
Receives: Other: Any treatment, watch and wait policy included

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: September 2024 (13 years)

Secondary outcomes (7)

  1. 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.

    Measured: September 2024 (13 years)

  2. 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.

    Measured: September 2024 (13 years)

  3. 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.

    Measured: September 2024 (13 years)

  4. 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.

    Measured: September 2017 (Six years)

  5. 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).

    Measured: September 2016 (Five years)

  6. 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.

    Measured: September 2024 (13 years)

  7. 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.

    Measured: September 2024 (13 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2016 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
370 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02904577
Sponsor's protocol ID
NF2010
Status last verified
Dec 2024
First submitted
6 Sep 2016
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 31292118

Questions about this trial

What is this clinical trial studying?

An observational study of Indolent B-Cell Lymphomas, run by Fondazione Italiana Linfomi - ETS at 46 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Italy, Brazil, Austria, France, Portugal and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival for the treated cohort (time frame: September 2024 (13 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02904577, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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