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

Last updated: January 15, 2025
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Chronic Lymphocytic Leukemia

Lymphocytic Leukemia, Chronic

Treatment

Venetoclax

Clinical Study ID

NCT04282811
CLL1920
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria

  1. Patients with R/R CLL fulfilling the eligibility criteria required by the VenetoclaxNamed 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 scheduledto 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 nationallocal laws indicating that the patients understand the purpose of the study and theyagree to give complete access to their medical records.

Exclusion

Exclusion Criteria:

None

Study Design

Total Participants: 321
Treatment Group(s): 1
Primary Treatment: Venetoclax
Phase:
Study Start date:
July 24, 2020
Estimated Completion Date:
October 31, 2025

Study Description

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).

Connect with a study center

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

    Cona, Ferrara
    Italy

    Active - Recruiting

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

    Alessandria,
    Italy

    Active - Recruiting

  • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

    Bari,
    Italy

    Active - Recruiting

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

    Cagliari,
    Italy

    Active - Recruiting

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

    Catania,
    Italy

    Active - Recruiting

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

    Catanzaro,
    Italy

    Active - Recruiting

  • Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia

    Cosenza,
    Italy

    Active - Recruiting

  • Aou Careggi - Firenze - Sod Ematologia

    Firenze,
    Italy

    Active - Recruiting

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

    Messina,
    Italy

    Active - Recruiting

  • Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia

    Milano,
    Italy

    Active - Recruiting

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

    Milano,
    Italy

    Active - Recruiting

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

    Milano,
    Italy

    Active - Recruiting

  • Aou Di Modena - Sc Ematologia

    Modena,
    Italy

    Active - Recruiting

  • Aou Maggiore Della Carita' Di Novara - Scdu Ematologia

    Novara,
    Italy

    Active - Recruiting

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

    Palermo,
    Italy

    Active - Recruiting

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

    Perugia,
    Italy

    Active - Recruiting

  • Aou Pisana - Uo Ematologia Universitaria

    Pisa,
    Italy

    Active - Recruiting

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

    Ravenna,
    Italy

    Active - Recruiting

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

    Reggio Calabria,
    Italy

    Active - Recruiting

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

    Reggio Emilia,
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

    Roma,
    Italy

    Active - Recruiting

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

    Roma,
    Italy

    Active - Recruiting

  • Ao S. Maria - Terni - Sc Onco Ematologia

    Terni,
    Italy

    Active - Recruiting

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

    Torino,
    Italy

    Active - Recruiting

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

    Torino,
    Italy

    Active - Recruiting

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

    Varese,
    Italy

    Active - Recruiting

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

    Verona,
    Italy

    Active - Recruiting

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