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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04867915
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : January 4, 2022
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Description
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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.


Condition or disease
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma MBL-CLL - Monoclonal B-Cell Lymphocytosis Chronic Lymphocytic Leukaemia-Type

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 Design
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Study Type : Observational
Estimated Enrollment : 12500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)
Actual Study Start Date : October 13, 2021
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

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:

  • - -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04867915


Contacts
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Contact: Paola Fazi 0670390528 p.fazi@gimema.it
Contact: Enrico Crea 0670390514 e.crea@gimema.it

Locations
Show Show 18 study locations
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
More Information
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT04867915    
Other Study ID Numbers: CLL2121
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: January 4, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphocytosis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Leukocytosis
Leukocyte Disorders
Hematologic Diseases