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

NCT04867915 · tracked via the Priya Life Science Italy tracker

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Phase

Observational

Started

2021-10-13

Last updated

2025-03-14

Condition(s) studied

Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMBL-CLL - Monoclonal B-Cell Lymphocytosis Chronic Lymphocytic Leukaemia-Type

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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: * \- -

Primary outcome measure(s)

Describe the diagnosis and management of CLL patients — 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

Trial sites (24)

Facility	City	Region	Status
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
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

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Other trials for the same condition

Fixed-duration Therapy With Ibrutinib and Obinutuzumab (GA-101) in Treatment-naïve Patients With CLL Recruiting

A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Recruiting

Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL Recruiting

A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04867915 on ClinicalTrials.gov ↗ ← All trials in Italy