Study on the Diagnosis and Management of CLL in Italy by GIMEMA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, MBL-CLL - Monoclonal B-Cell Lymphocytosis Chronic Lymphocytic Leukaemia-Type. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)
Overview
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.
Detailed description
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.
Primary outcome measures
- 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]
Eligibility criteria
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
- \- -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 24 centers
- Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia — Alessandria
- Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra — Brescia
- Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia — Brindisi
- Fondazione Del Piemonte Per L'Oncologia Centro Trapianti — Candiolo
- SOD ematologia AOU Careggi — Florence
- Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia — Messina
- UOC Ematologia AOU Policlinico "G. Martino" — Messina
- Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia — Mestre
- … and 16 more centers
Identifiers
NCT: NCT04867915 · CLL2121