Clinical Trials in Italy / NCT04282811
Active, not recruiting
Observational
Observational Study Relapsed or Refractory Chronic Lymphocytic Leukemia Venetoclax-based Regimens Outside Clinical Trials in Italy
NCT04282811 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Chronic Lymphocytic LeukemiaRelapse LeukemiaRefractory Leukemia
Investigational drug(s) / intervention(s)
Venetoclax: Patients treated with venetoclax-based regimens outside clinical trials in Italy
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
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
Primary outcome measure(s)
- 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. — 15 months
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
Trial sites (27)
| Facility | City | Region | Status |
|---|---|---|---|
| Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione | Cona | Ferrara | |
| 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 |
On this site
📄 Venclexta (venetoclax) drug profile →More Gruppo Italiano Malattie EMatologiche dell'Adulto trials in Italy
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04282811 on ClinicalTrials.gov ↗ ← All trials in Italy