Study on the Diagnosis and Management of CLL in Italy by GIMEMA
Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)
1 other identifier
observational
12,500
1 country
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2021
CompletedFirst Posted
Study publicly available on registry
April 30, 2021
CompletedStudy Start
First participant enrolled
October 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
March 14, 2025
March 1, 2025
5 years
April 28, 2021
March 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Describe the diagnosis and management of CLL patients
evaluation of CLL management in terms of time to first treatment
at 1 year for the prospective cohort and at 4 years for the retrospective cohort
Eligibility Criteria
All patients with CLL/SLL or MBL diagnosis followed at participant sites starting from January 1st, 2010 (retrospective cohort) and from September 1st, 2021 (prospective cohort).
You may qualify if:
- 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)
You may not qualify if:
- \- -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria, Italy
Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia
Brescia, Italy
Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia
Brindisi, Italy
Fondazione Del Piemonte Per L'Oncologia Centro Trapianti
Candiolo, Italy
SOD ematologia AOU Careggi
Florence, Italy
Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
Messina, Italy
UOC Ematologia AOU Policlinico "G. Martino"
Messina, Italy
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
Mestre, Italy
Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
Milan, Italy
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan, Italy
Ospedale San Raffaele
Milan, Italy
Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza, Italy
UOSD Ematologia Giovanni Paolo II
Ragusa, Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma, Italy
Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
Salerno, Italy
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
San Giovanni Rotondo, Italy
Aou Senese - Uoc Ematologia E Trapianti
Siena, Italy
Ao S. Maria - Terni - Sc Onco Ematologia
Terni, Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino, Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
Torino, Italy
Asl to 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia
Torino, Italy
UOC Ematologia PO Treviso
Treviso, Italy
UCO Ematologia ASUGI Trieste
Trieste, Italy
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Vicenza, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2021
First Posted
April 30, 2021
Study Start
October 13, 2021
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
March 14, 2025
Record last verified: 2025-03