NCT04282811Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 321 (estimated)
- First submitted
- 21 Feb 2020
- Start date
- 24 Jul 2020
- Primary completion date
- 31 Jan 2023
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT04282811
What you commit to
- Study type: Observational
- Planned participants: 321
- From 24 Jul 2020 to the primary completion date, 31 Jan 2023
- 27 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None
Who the study is looking for
- 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.
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia Coordinator of this site? Confirm its status | Alessandria | Italy | Unknown status |
| Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo Coordinator of this site? Confirm its status | Cagliari | Italy | Unknown status |
| Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione Coordinator of this site? Confirm its status | Cona | Italy | Unknown status |
| Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia Coordinator of this site? Confirm its status | Cosenza | Italy | Unknown status |
| Aou Careggi - Firenze - Sod Ematologia Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Aou Di Modena - Sc Ematologia Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| AOU Maggiore della Carità di Novara, SCDU Ematologia Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| Aou Pisana - Uo Ematologia Universitaria Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia Coordinator of this site? Confirm its status | Ravenna | Italy | Unknown status |
| Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia Coordinator of this site? Confirm its status | Reggio Calabria | Italy | Unknown status |
| Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ao S. Maria - Terni - Sc Onco Ematologia Coordinator of this site? Confirm its status | Terni | Italy | Unknown status |
| Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2 Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi - Uoc Ematologia Coordinator of this site? Confirm its status | Varese | Italy | Unknown status |
| Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.