RecruitingNCT04282811

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

An Observational Study to Evaluate the Clinical and Biologic Features and Outcome of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Treated With Venetoclax-based Regimens Outside Clinical Trials in Italy

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Enrollment

321 participants

Start Date

Jul 24, 2020

Study Type

OBSERVATIONAL

Conditions

Chronic Lymphocytic Leukemia Refractory Leukemia Relapse Leukemia

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an observational study (no new treatment given) that follows patients in Italy with chronic lymphocytic leukemia (CLL) — a slow-growing blood cancer — who are receiving a drug called venetoclax after their disease came back or stopped responding to previous treatment. **You may be eligible if...** - You have been diagnosed with relapsed or refractory CLL (leukemia that returned or isn't responding) - You have received at least one dose of venetoclax, or you are about to start it - You meet the criteria for the venetoclax patient access program in Italy **You may NOT be eligible if...** - You have not received venetoclax and are not scheduled to receive it - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

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

Locations(27)

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

Cona, Ferrara, Italy

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

Alessandria, Italy

Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

Bari, Italy

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

Cagliari, Italy

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

Catania, Italy

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

Catanzaro, Italy

Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia

Cosenza, Italy

Aou Careggi - Firenze - Sod Ematologia

Florence, Italy

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

Messina, Italy

Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia

Milan, Italy

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

Milan, Italy

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

Milan, Italy

Aou Di Modena - Sc Ematologia

Modena, Italy

Aou Maggiore Della Carita' Di Novara - Scdu Ematologia

Novara, Italy

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

Palermo, Italy

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

Perugia, Italy

Aou Pisana - Uo Ematologia Universitaria

Pisa, Italy

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

Ravenna, Italy

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

Reggio Calabria, Italy

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

Reggio Emilia, Italy

Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

Roma, Italy

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

Roma, 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

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

Varese, Italy

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

Verona, Italy

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NCT04282811

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