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

Last updated: March 12, 2025
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Platelet Disorders

Lymphocytic Leukemia, Chronic

Lymphoma

Treatment

N/A

Clinical Study ID

NCT04867915
CLL2121
  • Ages > 18
  • All Genders

Study 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.

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years at diagnosis

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

  3. Chronic lymphocytic leukemia (CLL)

  4. Small lymphocytic lymphoma (SLL)

  5. CLL-like monoclonal B-cell lymphocytosis (MBL)

  6. Retrospective cohort: CLL/SLL/MBL diagnosis between January 1st 2010 and August 31th

  8. Prospective cohort: CLL/SLL/MBL diagnosis between September 1st 2021 and September 1st, 2025.

  9. Signed written informed consent according to ICH/EU/GCP and national local laws (ifapplicable)

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 12500
Study Start date:
October 13, 2021
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

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

    Alessandria,
    Italy

    Active - Recruiting

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

    Brescia,
    Italy

    Active - Recruiting

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

    Brindisi,
    Italy

    Active - Recruiting

  • Fondazione Del Piemonte Per L'Oncologia Centro Trapianti

    Candiolo,
    Italy

    Active - Recruiting

  • SOD ematologia AOU Careggi

    Firenze,
    Italy

    Active - Recruiting

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

    Messina,
    Italy

    Active - Recruiting

  • UOC Ematologia AOU Policlinico "G. Martino"

    Messina,
    Italy

    Active - Recruiting

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

    Mestre,
    Italy

    Active - Recruiting

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

    Milano,
    Italy

    Active - Recruiting

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

    Milano,
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milano,
    Italy

    Active - Recruiting

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

    Piacenza,
    Italy

    Active - Recruiting

  • UOSD Ematologia Giovanni Paolo II

    Ragusa,
    Italy

    Active - Recruiting

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

    Roma,
    Italy

    Active - Recruiting

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

    Salerno,
    Italy

    Active - Recruiting

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

    San Giovanni Rotondo,
    Italy

    Active - Recruiting

  • Aou Senese - Uoc Ematologia E Trapianti

    Siena,
    Italy

    Active - Recruiting

  • Ao S. Maria - Terni - Sc Onco Ematologia

    Terni,
    Italy

    Active - Recruiting

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

    Torino,
    Italy

    Active - Recruiting

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

    Torino,
    Italy

    Active - Recruiting

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

    Torino,
    Italy

    Active - Recruiting

  • UOC Ematologia PO Treviso

    Treviso,
    Italy

    Active - Recruiting

  • UCO Ematologia ASUGI Trieste

    Trieste,
    Italy

    Active - Recruiting

  • Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

    Vicenza,
    Italy

    Active - Recruiting

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