Actively Recruiting
Observational Study of Clinical Features and Outcomes in Relapsed or Refractory Chronic Lymphocytic Leukemia Treated With Venetoclax-Based Regimens Outside Clinical Trials in Italy
Led by Gruppo Italiano Malattie EMatologiche dell'Adulto · Updated on 2025-01-17
321
Participants Needed
27
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study focuses on patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) who have been treated with venetoclax-based regimens outside of clinical trials in Italy. The goal is to describe the characteristics and outcomes of these patients over a period extending from the start of the Venetoclax Named Patient Program in March 2016 until June 30th, 2025. The study is sponsored by the Gruppo Italiano Malattie EMatologiche dell'Adulto and aims to understand real-world use of venetoclax in this setting. The study includes two groups: a retrospective group consisting of patients who have already received at least one dose of venetoclax before enrollment, and a prospective group that includes patients starting venetoclax treatment after joining the study. All patients will be monitored for up to 48 months from the start of their treatment. In the prospective group, researchers will assess quality of life and how well patients adhere to their treatment schedule at multiple time points including baseline and several follow-up months, as well as when treatment ends for any reason. Participants will have their clinical and biological features observed alongside their treatment outcomes, including progression-free survival over 15 months. Data collection involves reviewing medical records and conducting regular assessments for those in the prospective group. The study period allows researchers to track long-term effects and patient experiences with venetoclax outside of controlled trial settings, providing valuable insights into its use in everyday clinical practice.
CONDITIONS
Brief Title
Observational Study Relapsed or Refractory Chronic Lymphocytic Leukemia Venetoclax-based Regimens Outside Clinical Trials in Italy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) who meet the Venetoclax Named Patient Program eligibility criteria and have received at least one dose of venetoclax.
- Patients with CLL who have received at least one dose of venetoclax or are scheduled to start venetoclax treatment before June 30, 2025.
- Signed informed consent indicating understanding of the study purpose and agreeing to provide complete access to medical records, if feasible.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 months from treatment start
Participants who have received at least one dose of venetoclax are observed to describe clinical characteristics and outcomes.
Visits at baseline and every 3 months up to 48 months, plus at treatment discontinuation (prospective group only)
Trial Site Locations
Total: 27 locations
1
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
Cona, Ferrara, Italy
Actively Recruiting
2
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria, Italy
Actively Recruiting
3
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, Italy
Actively Recruiting
4
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
Cagliari, Italy
Actively Recruiting
5
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
Catania, Italy
Actively Recruiting
6
Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia
Catanzaro, Italy
Actively Recruiting
7
Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia
Cosenza, Italy
Actively Recruiting
8
Aou Careggi - Firenze - Sod Ematologia
Florence, Italy
Actively Recruiting
9
Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
Messina, Italy
Actively Recruiting
10
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan, Italy
Actively Recruiting
11
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan, Italy
Actively Recruiting
12
Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B
Milan, Italy
Actively Recruiting
13
Aou Di Modena - Sc Ematologia
Modena, Italy
Actively Recruiting
14
Aou Maggiore Della Carita' Di Novara - Scdu Ematologia
Novara, Italy
Actively Recruiting
15
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
Palermo, Italy
Actively Recruiting
16
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
Perugia, Italy
Actively Recruiting
17
Aou Pisana - Uo Ematologia Universitaria
Pisa, Italy
Actively Recruiting
18
Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia
Ravenna, Italy
Actively Recruiting
19
Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia
Reggio Calabria, Italy
Actively Recruiting
20
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Reggio Emilia, Italy
Actively Recruiting
21
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma, Italy
Actively Recruiting
22
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
Roma, Italy
Actively Recruiting
23
Ao S. Maria - Terni - Sc Onco Ematologia
Terni, Italy
Actively Recruiting
24
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino, Italy
Actively Recruiting
25
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
Torino, Italy
Actively Recruiting
26
Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi - Uoc Ematologia
Varese, Italy
Actively Recruiting
27
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Verona, Italy
Actively Recruiting
Research Team
P
Paola Fazi
E
Enrico Crea
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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