Clinical trial Recruiting at 24 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment12500 (estimated)
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto
Academic / other
Locations24 sites (Alessandria and 23 other locations)
StatusRecruiting
StartedOctober 13, 2021
Main results expectedOctober 2026
Study endsOctober 2026
Registry record updatedMarch 14, 2025
Trial IDNCT04867915 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • 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.

    Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07734038

  • 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.

    Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07582159

  • 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.

    Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07557056

  • 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.

    Recruiting at 5 sites Phase 1/2 Nurix Therapeutics, Inc. · Aurora, Colorado and 8 other locations · NCT07520006

  • 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.

    Recruiting at 6 sites Phase 3 Nurix Therapeutics, Inc. · Macon, Georgia and 5 other locations · NCT07516093

  • 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.

    Recruiting Phase 1 Case Comprehensive Cancer Center · Cleveland, Ohio and 1 other locations · NCT07225439

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.