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

Recruiting

• Conditions: MBL-CLL - Monoclonal B-Cell Lymphocytosis Chronic Lymphocytic Leukaemia-Type; Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

• Registration Number: NCT04867915
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

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.

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-04-30
• Study Start: 2021-10-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (24)

Fondazione Del Piemonte Per L'Oncologia Centro Trapianti; 🇮🇹 Candiolo, Italy

SOD ematologia AOU Careggi; 🇮🇹 Firenze, Italy

UOC Ematologia AOU Policlinico "G. Martino"; 🇮🇹 Messina, Italy

UOSD Ematologia Giovanni Paolo II; 🇮🇹 Ragusa, Italy

UOC Ematologia PO Treviso; 🇮🇹 Treviso, Italy

UCO Ematologia ASUGI Trieste; 🇮🇹 Trieste, Italy

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

Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia; 🇮🇹 Messina, Italy

Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia; 🇮🇹 Mestre, Italy

Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia; 🇮🇹 Milano, Italy

Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora; 🇮🇹 Milano, Italy

Ospedale San Raffaele; 🇮🇹 Milano, Italy

Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti; 🇮🇹 Piacenza, 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

Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia; 🇮🇹 Vicenza, Italy