AzTrials
AzTrials

Chronic Lymphocytic LeukemiaNCT04867915

Study on the Diagnosis and Management of CLL in Italy by GIMEMA

An observational study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 24 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

retrospective and prospective multicenter observational clinical and biological data collection from all patients with newly diagnosed CLL, SLL or MBL. retrospective cohort: all cases with a diagnosis between January 1st 2010 and August 31th 2021. Read more about this study

Who is it for?
Ages 18 years and older
How many people
12,500 participants
Where
24 sitesItaly
Study dates
13 Oct 2021to Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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: All patients with CLL/SLL or MBL diagnosis followed at participant sites starting from January 1st, 2010 (retrospective cohort) and from September 1st, 2021 (prospective cohort).

Who may be able to join

  • Age ≥18 years at diagnosis
  • One of the following diagnoses that meet the international diagnostic criteria (iwCLL2018 and WHO2017)
  • Chronic lymphocytic leukemia (CLL)
  • Small lymphocytic lymphoma (SLL)
  • CLL-like monoclonal B-cell lymphocytosis (MBL)
  • Retrospective cohort: CLL/SLL/MBL diagnosis between January 1st 2010 and August 31th 2021.
  • Prospective cohort: CLL/SLL/MBL diagnosis between September 1st 2021 and September 1st, 2025.
  • Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable)

Who cannot join

  • - -

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Paola Fazi contact

0670390528

p.fazi@gimema.it

Enrico Crea contact

0670390514

e.crea@gimema.it

24 sites in 1 country

Italy24 sites, 24 recruiting

  • Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia

    Alessandria

    Daniela Pietrasanta, dpietrasanta@ospedale.al.it

    Recruiting

  • Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia

    Brescia

    Michele Malagola, 3494628987, malagola@med.unibs.it

    Recruiting

  • Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia

    Brindisi

    Domenico Pastore, 3393061521, domenico.pastore0@gmail.com

    Recruiting

  • Fondazione Del Piemonte Per L'Oncologia Centro Trapianti

    Candiolo

    Umberto Vitolo

    Recruiting

  • SOD ematologia AOU Careggi

    Florence

    Alessandro Sanna

    Recruiting

  • Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia

    Messina

    Donato Mannina, donamanni@gmail.com

    Recruiting

  • UOC Ematologia AOU Policlinico "G. Martino"

    Messina

    Giuseppina Penna

    Recruiting

  • Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia

    Mestre

    Rosaria Sancetta, rosaria.sancetta@aulss3.veneto.it

    Recruiting

  • Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia

    Milan

    Lucia Farina, lucia.farina@istitutotumori.mi.it

    Recruiting

  • Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora

    Milan

    Gianluigi Reda, gianluigi.reda@policlinico.mi.it

    Recruiting

  • Ospedale San Raffaele

    Milan

    Paolo Ghia

    Recruiting

  • Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti

    Piacenza

    Daniele Vallisa, d.vallisa@ausl.pc.it

    Recruiting

  • UOSD Ematologia Giovanni Paolo II

    Ragusa

    Sergio Cabibbo

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

    Roma

    Luca Laurenti, 3386743346, luca.laurenti@Unicatt.it

    Recruiting

  • Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche

    Salerno

    Carmine Selleri, 3356166591, cselleri@unisa.it

    Recruiting

  • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia

    San Giovanni Rotondo

    Potito Rosario Scalzulli, p.scalzulli@operapadrepio.it

    Recruiting

  • Aou Senese - Uoc Ematologia E Trapianti

    Siena

    Alessandro Gozzetti, gozzetti@unisi.it

    Recruiting

  • Ao S. Maria - Terni - Sc Onco Ematologia

    Terni

    Marina Liberati, 3356291390, marina.liberati@unipg.it

    Recruiting

  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino

    Torino

    Marta Coscia, marta.coscia@unito.it

    Recruiting

  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2

    Torino

    Lorella Orsucci, lorsucci@cittadellasalute.to.it

    Recruiting

  • Asl to 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia

    Torino

    Massimo Pini, 3389482076, massimo.pini@aslcittaditorino.it

    Recruiting

  • UOC Ematologia PO Treviso

    Treviso

    Francesca Cibien

    Recruiting

  • UCO Ematologia ASUGI Trieste

    Trieste

    Francesco Zaja

    Recruiting

  • Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

    Vicenza

    Davide Facchinelli, davide.facchinelli@aulss8.veneto.it

    Recruiting

Other trials in Italy

About this study

Official title: Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)

retrospective and prospective multicenter observational clinical and biological data collection from all patients with newly diagnosed CLL, SLL or MBL.

retrospective cohort: all cases with a diagnosis between January 1st 2010 and August 31th 2021.

prospective cohort: all patients with a diagnosis between September 1st 2021 and September 1st 2025.

Read the detailed description

This is a retrospective and prospective multicenter observational study designed by the Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA). The study consists of clinical and biological data collection from all patients with newly diagnosed CLL, SLL or MBL (according to the WHO 2007 and 2018 diagnostic criteria). The retrospective part aims at including all cases followed at participating centers with a diagnosis between January 1st 2010 and August 31th 2021 (planned study initiation), while the prospective part will include all patients with a documented diagnosis of CLL, SLL or MBL between September 1st 2021 and September 1st 2025 by the first immunophenotypic/histological evaluation. The data is collected through electronic case report form accessible by the participating centers on a dedicated platform.

Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What is being measured

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

  1. Describe the diagnosis and management of CLL patients

    evaluation of CLL management in terms of time to first treatment

    Measured: at 1 year for the prospective cohort and at 4 years for the retrospective cohort

Timeline

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

  1. First posted30 Apr 2021
  2. Study start13 Oct 2021
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

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
Case only
Time perspective
Prospective
Enrolment
12,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04867915
Sponsor's protocol ID
CLL2121
Status last verified
Mar 2025
First submitted
28 Apr 2021
Last updated
14 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 24 sites in Italy.

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 8 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: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Italy. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Describe the diagnosis and management of CLL patients (time frame: at 1 year for the prospective cohort and at 4 years for the retrospective cohort). 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 NCT04867915.

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 14 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in