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

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)
Overall Status
Recruiting
CT.gov ID
NCT04867915
Collaborator
(none)
12,500
Enrollment
18
Locations
59.6
Anticipated Duration (Months)
694.4
Patients Per Site
11.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    12500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)
    Actual Study Start Date :
    Oct 13, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2026
    Anticipated Study Completion Date :
    Oct 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Describe the diagnosis and management of CLL patients [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 (if applicable)

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia Alessandria Italy
    2 Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia Brescia Italy
    3 Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia Brindisi Italy
    4 Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia Messina Italy
    5 Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia Mestre Italy
    6 Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia Milano Italy
    7 Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora Milano Italy
    8 Ospedale San Raffaele Milano Italy
    9 Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti Piacenza Italy
    10 Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica Roma Italy
    11 Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche Salerno Italy
    12 Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia San Giovanni Rotondo Italy
    13 Aou Senese - Uoc Ematologia E Trapianti Siena Italy
    14 Ao S. Maria - Terni - Sc Onco Ematologia Terni Italy
    15 Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino Torino Italy
    16 Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2 Torino Italy
    17 Asl to 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia Torino Italy
    18 Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia Vicenza Italy

    Sponsors and Collaborators

    • Gruppo Italiano Malattie EMatologiche dell'Adulto

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gruppo Italiano Malattie EMatologiche dell'Adulto
    ClinicalTrials.gov Identifier:
    NCT04867915
    Other Study ID Numbers:
    • CLL2121
    First Posted:
    Apr 30, 2021
    Last Update Posted:
    Jan 4, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell
    Lymphocytosis

    Study Results

    No Results Posted as of Jan 4, 2022