Observational Study Relapsed or Refractory Chronic Lymphocytic Leukemia Venetoclax-based Regimens Outside Clinical Trials in Italy

NCT ID: NCT04282811

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

321 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-24

Study Completion Date

2025-10-31

Brief Summary

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Observational study aimed at describing the characteristics and outcome of CLL patients who started treatment with venetoclax-based regimens according to the local label outside clinical trials in Italy in a period of time ranging from the start of the Venetoclax Named Patient Program (March 2016) until June 30th, 2025.

Detailed Description

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Observational study to describe the characteristics and outcome of CLL patients treated with venetoclax according to the local label. The study includes two different groups: a retrospective group (all patients who have received at least one dose of venetoclax before enrolment) and a prospective group (patients receiving treatment with venetoclax after enrolment). All patients in both groups will be observed for up to 48 months from the treatment start. In the prospective cohort only, QoL and treatment adherence will be assessed at the time of study entry (i.e. baseline) and thereafter at 3, 6, 9, 12, 18 24, 30, 36, 42 and 48 months of follow-up and at treatment discontinuation (due to any cause).

Conditions

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Chronic Lymphocytic Leukemia Relapse Leukemia Refractory Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cohort group

Patients who have received at least one dose of venetoclax

Venetoclax

Intervention Type DRUG

Patients treated with venetoclax-based regimens outside clinical trials in Italy

Interventions

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Venetoclax

Patients treated with venetoclax-based regimens outside clinical trials in Italy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients with R/R CLL fulfilling the eligibility criteria required by the Venetoclax Named Patient Program who have received at least 1 dose of venetoclax.
2. Patients with CLL who have received at least 1 dose of venetoclax or are scheduled to start treatment with venetoclax according to the Post-marketing Use before June 30th, 2025.
3. Signed informed consent document (if feasible) according to ICH/EU/GCP and national local laws indicating that the patients understand the purpose of the study and they agree to give complete access to their medical records.

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione

Cona, Ferrara, Italy

Site Status RECRUITING

Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia

Alessandria, , Italy

Site Status RECRUITING

Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

Bari, , Italy

Site Status RECRUITING

Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo

Cagliari, , Italy

Site Status RECRUITING

Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania

Catania, , Italy

Site Status RECRUITING

Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia

Catanzaro, , Italy

Site Status RECRUITING

Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia

Cosenza, , Italy

Site Status RECRUITING

Aou Careggi - Firenze - Sod Ematologia

Florence, , Italy

Site Status RECRUITING

Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia

Messina, , Italy

Site Status RECRUITING

Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia

Milan, , Italy

Site Status RECRUITING

Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora

Milan, , Italy

Site Status RECRUITING

Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B

Milan, , Italy

Site Status RECRUITING

Aou Di Modena - Sc Ematologia

Modena, , Italy

Site Status RECRUITING

Aou Maggiore Della Carita' Di Novara - Scdu Ematologia

Novara, , Italy

Site Status RECRUITING

Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo

Palermo, , Italy

Site Status RECRUITING

Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo

Perugia, , Italy

Site Status RECRUITING

Aou Pisana - Uo Ematologia Universitaria

Pisa, , Italy

Site Status RECRUITING

Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia

Ravenna, , Italy

Site Status RECRUITING

Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia

Reggio Calabria, , Italy

Site Status RECRUITING

Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia

Reggio Emilia, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

Roma, , Italy

Site Status RECRUITING

Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia

Roma, , Italy

Site Status RECRUITING

Ao S. Maria - Terni - Sc Onco Ematologia

Terni, , Italy

Site Status RECRUITING

Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino

Torino, , Italy

Site Status RECRUITING

Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2

Torino, , Italy

Site Status RECRUITING

Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi - Uoc Ematologia

Varese, , Italy

Site Status RECRUITING

Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia

Verona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paola Fazi

Role: CONTACT

0670390528

Enrico Crea

Role: CONTACT

0670390514

Facility Contacts

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GianMatteo Rigolin

Role: primary

Daniela S Pietrasanta

Role: primary

Francesco C Albano

Role: primary

Roberta Murru

Role: primary

Annalisa Chiarenza

Role: primary

Monica Stefano

Role: primary

Massimo Gentile

Role: primary

Sanna Alessandro

Role: primary

Donato Mannina

Role: primary

Alessandra Tedeschi

Role: primary

Gianluigi P Reda

Role: primary

Lydia Scarfò

Role: primary

Roberto Marasca

Role: primary

Gianluca Gaidano

Role: primary

Caterina Patti

Role: primary

Paolo Sportoletti

Role: primary

Sara Galimberti

Role: primary

Monica Tani

Role: primary

Caterina Stelitano

Role: primary

Angela Ferrari

Role: primary

Luca Laurenti

Role: primary

Francesca R Mauro

Role: primary

Anna Marina Liberati

Role: primary

Marta Coscia

Role: primary

Lorella Orsucci

Role: primary

Andrea Ferrario

Role: primary

Francesca Maria Quaglia

Role: primary

Other Identifiers

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CLL1920

Identifier Type: -

Identifier Source: org_study_id

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