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

March 12, 2025 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

12500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Alessandria, Italy
        • Recruiting
        • Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
        • Contact:
      • Brescia, Italy
        • Recruiting
        • Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia
        • Contact:
      • Brindisi, Italy
        • Recruiting
        • Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia
        • Contact:
      • Candiolo, Italy
        • Recruiting
        • Fondazione Del Piemonte Per L'Oncologia Centro Trapianti
        • Contact:
          • Umberto Vitolo
      • Firenze, Italy
        • Recruiting
        • SOD ematologia AOU Careggi
        • Contact:
          • Alessandro Sanna
      • Messina, Italy
        • Recruiting
        • Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
        • Contact:
      • Messina, Italy
        • Recruiting
        • UOC Ematologia AOU Policlinico "G. Martino"
        • Contact:
          • Giuseppina Penna
      • Mestre, Italy
      • Milano, Italy
      • Milano, Italy
        • Recruiting
        • Ospedale San Raffaele
        • Contact:
          • Paolo Ghia
      • Milano, Italy
        • Recruiting
        • Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
        • Contact:
      • Piacenza, Italy
        • Recruiting
        • Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
        • Contact:
      • Ragusa, Italy
        • Recruiting
        • UOSD Ematologia Giovanni Paolo II
        • Contact:
          • Sergio Cabibbo
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
        • Contact:
      • Salerno, Italy
        • Recruiting
        • Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
        • Contact:
      • San Giovanni Rotondo, Italy
        • Recruiting
        • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
        • Contact:
      • Siena, Italy
        • Recruiting
        • Aou Senese - Uoc Ematologia E Trapianti
        • Contact:
      • Terni, Italy
        • Recruiting
        • Ao S. Maria - Terni - Sc Onco Ematologia
        • Contact:
      • Torino, Italy
        • Recruiting
        • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
        • Contact:
      • Torino, Italy
        • Recruiting
        • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
        • Contact:
      • Torino, Italy
        • Recruiting
        • Asl to 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia
        • Contact:
      • Treviso, Italy
        • Recruiting
        • UOC Ematologia PO Treviso
        • Contact:
          • Francesca Cibien
      • Trieste, Italy
        • Recruiting
        • UCO Ematologia ASUGI Trieste
        • Contact:
          • Francesco Zaja
      • Vicenza, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  1. Age ≥18 years at diagnosis

  2. One of the following diagnoses that meet the international diagnostic criteria (iwCLL2018 and WHO2017)

    1. Chronic lymphocytic leukemia (CLL)
    2. Small lymphocytic lymphoma (SLL)
    3. CLL-like monoclonal B-cell lymphocytosis (MBL)
  3. Retrospective cohort: CLL/SLL/MBL diagnosis between January 1st 2010 and August 31th 2021.
  4. Prospective cohort: CLL/SLL/MBL diagnosis between September 1st 2021 and September 1st, 2025.
  5. Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable)

Exclusion Criteria:

  • - -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
evaluation of CLL management in terms of time to first treatment
at 1 year for the prospective cohort and at 4 years for the retrospective cohort

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2021

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLL2121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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