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
1 other identifier
observational
321
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedStudy Start
First participant enrolled
July 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedJanuary 17, 2025
January 1, 2025
2.5 years
February 21, 2020
January 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
cohort group
Patients who have received at least one dose of venetoclax
Interventions
Patients treated with venetoclax-based regimens outside clinical trials in Italy
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2020
First Posted
February 25, 2020
Study Start
July 24, 2020
Primary Completion
January 31, 2023
Study Completion
October 31, 2025
Last Updated
January 17, 2025
Record last verified: 2025-01