Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)
| NCT number | NCT04867915 |
| Other study ID # | CLL2121 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 13, 2021 |
| Est. completion date | October 2026 |
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.
| Status | Recruiting |
| Enrollment | 12500 |
| Est. completion date | October 2026 |
| Est. primary completion date | October 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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: - - - |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia | Alessandria | |
| Italy | Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia | Brescia | |
| Italy | Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia | Brindisi | |
| Italy | Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia | Messina | |
| Italy | Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia | Mestre | |
| Italy | Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia | Milano | |
| Italy | Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora | Milano | |
| Italy | Ospedale San Raffaele | Milano | |
| Italy | Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti | Piacenza | |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica | Roma | |
| Italy | Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche | Salerno | |
| Italy | Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia | San Giovanni Rotondo | |
| Italy | Aou Senese - Uoc Ematologia E Trapianti | Siena | |
| Italy | Ao S. Maria - Terni - Sc Onco Ematologia | Terni | |
| Italy | Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino | Torino | |
| Italy | Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2 | Torino | |
| Italy | Asl to 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia | Torino | |
| Italy | Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia | Vicenza |
| Lead Sponsor | Collaborator |
|---|---|
| Gruppo Italiano Malattie EMatologiche dell'Adulto |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Describe the diagnosis and management of CLL patients | 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 |
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