Collecting data on Chronic Lymphocytic Leukemia in Italy
Official title: Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)
Run by Gruppo Italiano Malattie EMatologiche dell'Adulto · NCT04867915 · Data updated 2026-11-12
This study is collecting information from patients newly diagnosed with Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Monoclonal B-Cell Lymphocytosis in Italy to better understand these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12500 (estimated) |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto Academic / other |
| Locations | 24 sites (Alessandria and 23 other locations) |
| Status | Recruiting |
| Started | October 13, 2021 |
| Main results expected | October 2026 |
| Study ends | October 2026 |
| Registry record updated | March 14, 2025 |
| Trial ID | NCT04867915 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have been newly diagnosed with CLL, SLL, or MBL.
✕Probably not a fit
Patients who do not meet the diagnostic criteria for CLL, SLL, or MBL, or those diagnosed before January 2010 or after September 2025, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study, conducted by the Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA), aims to gather clinical and biological data from patients newly diagnosed with Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), or Monoclonal B-Cell Lymphocytosis (MBL). It includes both retrospective data from cases diagnosed between January 2010 and August 2021, and prospective data from patients diagnosed between September 2021 and September 2025. Data will be collected through a dedicated electronic case report form accessible to participating centers.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and management of CLL, SLL, and MBL, leading to improved patient outcomes.
How similar studies have gone: While this study follows established diagnostic criteria, similar observational studies have shown success in improving understanding and treatment of hematological conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
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: * \- -
Where it's running
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Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria, Italy Recruiting -
Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia
Brescia, Italy Recruiting -
Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia
Brindisi, Italy Recruiting -
Fondazione Del Piemonte Per L'Oncologia Centro Trapianti
Candiolo, Italy Recruiting -
SOD ematologia AOU Careggi
Florence, Italy Recruiting -
Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
Messina, Italy Recruiting
Show 18 more locations
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UOC Ematologia AOU Policlinico "G. Martino"
Messina, Italy Recruiting -
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
Mestre, Italy Recruiting -
Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
Milan, Italy Recruiting -
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan, Italy Recruiting -
Ospedale San Raffaele
Milan, Italy Recruiting -
Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza, Italy Recruiting -
UOSD Ematologia Giovanni Paolo II
Ragusa, Italy Recruiting -
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma, Italy Recruiting -
Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
Salerno, Italy Recruiting -
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
San Giovanni Rotondo, Italy Recruiting -
Aou Senese - Uoc Ematologia E Trapianti
Siena, Italy Recruiting -
Ao S. Maria - Terni - Sc Onco Ematologia
Terni, Italy Recruiting -
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino, Italy Recruiting -
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
Torino, Italy Recruiting -
Asl to 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia
Torino, Italy Recruiting -
UOC Ematologia PO Treviso
Treviso, Italy Recruiting -
UCO Ematologia ASUGI Trieste
Trieste, Italy Recruiting -
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Vicenza, Italy Recruiting
Study contacts
- Study coordinator: Paola Fazi
- Email: p.fazi@gimema.it
- Phone: 0670390528
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Venetoclax plus Zanubrutinib for CLL/SLL in frontline or previously treated patients
This phase II trial tests if venetoclax plus zanubrutinib can safely and effectively treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, including those who are newly diagnosed and those who have had prior therapy.
-
Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL
This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.
-
Nemtabrutinib and venetoclax in untreated CLL/SLL
This phase 2 study tests whether combining nemtabrutinib with venetoclax can help people with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
-
NX-5948 plus other medicines for B-cell cancers
This trial tests NX-5948 in combination with venetoclax, with or without anti-CD20 antibodies, for adults with CLL/SLL or B-cell lymphoma that has returned or worsened or is newly diagnosed but needing treatment.
-
NX-5948 vs Pirtobrutinib in R/R CLL/SLL
This study tests NX-5948 against pirtobrutinib in people with relapsed or refractory CLL/SLL who have previously tried a covalent BTK inhibitor.
-
Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL
This trial tests whether giving allogeneic NK cells with Rituximab, Tafasitamab, and IL-2 can help people with relapsed or refractory B-cell non-Hodgkin lymphoma who have tried at least two prior therapies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.