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NCT04282811 Clinical Trial

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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04282811
Other study ID # CLL1920
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 24, 2020
Est. completion date October 31, 2025

Study information
Verified date January 2022
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone 0670390528
Email p.fazi@gimema.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 October 31st, 2021.

Description:

A longitudinal survey will be carried out by collecting data of patients who received at least 1 dose of venetoclax. 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 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 157
Est. completion date October 31, 2025
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 R/R 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 October 31st, 2021. 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Venetoclax
Patients treated with venetoclax-based regimens outside clinical trials in Italy

Locations
Country Name City State
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 Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione Cona Ferrara
Italy Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia Cosenza
Italy Aou Careggi - Firenze - Sod Ematologia Firenze
Italy Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia Messina
Italy Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia Milano
Italy Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora Milano
Italy Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B Milano
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

Sponsors (1)
Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Estimation of the PFS in relapsed/refractory (R/R) patients with CLL treated with venetoclax-based regimens according to the local label outside clinical trials in Italy. Estimation of the PFS at 15 months from the start of venetoclax treatment in patients with R/R CLL who started treatment with venetoclax-based regimens according to the local label from the start of the Venetoclax Named Patient Program (March 2016) until October 31st, 2021 15 months
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