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NCT Number: NCT04867915

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

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.

Recruiting

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years at diagnosis
  • One of the following diagnoses that meet the international diagnostic criteria (iwCLL2018 and WHO2017)
  • Chronic lymphocytic leukemia (CLL)
  • Small lymphocytic lymphoma (SLL)
  • CLL-like monoclonal B-cell lymphocytosis (MBL)
  • Retrospective cohort: CLL/SLL/MBL diagnosis between January 1st 2010 and August 31th 2021.
  • Prospective cohort: CLL/SLL/MBL diagnosis between September 1st 2021 and September 1st, 2025.
  • Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable)

Exclusion criteria

  • - -

Treatment and study plan

Primary outcomes

  1. Describe the diagnosis and management of CLL patients

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Enrico Crea

CONTACT

[email protected]

0670390514

Paola Fazi

CONTACT

[email protected]

0670390528

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2021
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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