Observational Study Relapsed or Refractory Chronic Lymphocytic Leukemia Venetoclax-based Regimens Outside Clinical Trials in Italy
- Conditions
- Chronic Lymphocytic LeukemiaRelapse LeukemiaRefractory Leukemia
- Interventions
- Registration Number
- NCT04282811
- Brief 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.
- Detailed 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 321
Not provided
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description cohort group Venetoclax Patients who have received at least one dose of venetoclax
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
🇮🇹Bari, Italy
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
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
🇮🇹Cagliari, Italy
Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia
🇮🇹Catanzaro, Italy
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
🇮🇹Catania, Italy
Aou Careggi - Firenze - Sod Ematologia
🇮🇹Firenze, Italy
Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia
🇮🇹Cosenza, Italy
Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
🇮🇹Messina, Italy
Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B
🇮🇹Milano, Italy
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
🇮🇹Milano, Italy
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
🇮🇹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
Aou Pisana - Uo Ematologia Universitaria
🇮🇹Pisa, Italy
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
🇮🇹Perugia, Italy
Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia
🇮🇹Ravenna, Italy
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
🇮🇹Reggio Emilia, Italy
Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia
🇮🇹Reggio Calabria, Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
🇮🇹Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
🇮🇹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
Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi - Uoc Ematologia
🇮🇹Varese, Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
🇮🇹Torino, Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
🇮🇹Verona, Italy