Observational Study Relapsed or Refractory Chronic Lymphocytic Leukemia Venetoclax-based Regimens Outside Clinical Trials in Italy

Recruiting

• Conditions: Chronic Lymphocytic Leukemia; Relapse Leukemia; Refractory Leukemia
• Interventions: Drug: Venetoclax

• Registration Number: NCT04282811
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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).

Study Timeline

• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-25
• Study Start: 2020-07-24
• Primary Completion: 2023-01-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

Not provided

Exclusion Criteria

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

Trial Locations

Locations (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; 🇮🇹 Firenze, Italy

Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia; 🇮🇹 Messina, Italy

Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia; 🇮🇹 Milano, Italy

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