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Collecting data on Chronic Lymphocytic Leukemia in Italy

Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)

Observational Gruppo Italiano Malattie EMatologiche dell'Adulto · NCT04867915

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
Enrollment12500 (estimated)
Ages18 Years and up
SexAll
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto Academic / other
Locations24 sites (Alessandria and 23 other locations)
Trial IDNCT04867915 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been newly diagnosed with CLL, SLL, or MBL.

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.

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 performed: While this study follows established diagnostic criteria, similar observational studies have shown success in improving understanding and treatment of hematological conditions.

Eligibility criteria

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 this trial is running

Alessandria and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMBL-CLL - Monoclonal B-Cell Lymphocytosis Chronic Lymphocytic Leukaemia-Type
Last reviewed 2026-06-15 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.