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

January 3, 2022 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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 October 31st, 2021.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A longitudinal survey will be carried out by collecting data of patients who received at least 1 dose of venetoclax. 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 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 Type

Observational

Enrollment (Anticipated)

157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • Recruiting
        • Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
        • Contact:
      • Bari, Italy
        • Recruiting
        • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
        • Contact:
      • Cagliari, Italy
        • Recruiting
        • Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
        • Contact:
      • Catania, Italy
      • Catanzaro, Italy
        • Recruiting
        • Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia
        • Contact:
      • Cosenza, Italy
        • Recruiting
        • Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia
        • Contact:
      • Firenze, Italy
        • Recruiting
        • Aou Careggi - Firenze - Sod Ematologia
        • Contact:
          • Sanna Alessandro
      • Messina, Italy
        • Recruiting
        • Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
      • Milano, Italy
        • Recruiting
        • Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B
        • Contact:
          • Lydia Scarfò
      • Milano, Italy
        • Recruiting
        • Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
        • Contact:
          • Alessandra Tedeschi
      • Milano, Italy
        • Recruiting
        • Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
        • Contact:
      • Modena, Italy
        • Recruiting
        • Aou Di Modena - Sc Ematologia
        • Contact:
          • Roberto Marasca
      • Novara, Italy
        • Recruiting
        • Aou Maggiore Della Carita' Di Novara - Scdu Ematologia
      • Palermo, Italy
      • Perugia, Italy
        • Recruiting
        • Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
        • Contact:
      • Pisa, Italy
      • Ravenna, Italy
        • Recruiting
        • Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia
        • Contact:
      • Reggio Calabria, Italy
        • Recruiting
        • Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia
        • Contact:
      • Reggio Emilia, Italy
        • Recruiting
        • Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
        • Contact:
      • Roma, Italy
        • Recruiting
        • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
        • Contact:
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
        • Contact:
      • Terni, Italy
        • Recruiting
        • Ao S. Maria - Terni - Sc Onco Ematologia
      • Torino, Italy
        • Recruiting
        • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
      • Torino, Italy
        • Recruiting
        • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
      • Varese, Italy
      • Verona, Italy
    • Ferrara
      • Cona, Ferrara, Italy
        • Recruiting
        • Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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 October 31st, 2021.

Description

Inclusion Criteria

  1. 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.
  2. Patients with R/R 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 October 31st, 2021.
  3. 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.

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cohort group
Patients who have received at least one dose of venetoclax
Drug: Venetoclax
Patients treated with venetoclax-based regimens outside clinical trials in Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 24, 2020

Primary Completion (ANTICIPATED)

January 31, 2023

Study Completion (ANTICIPATED)

October 31, 2025

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (ACTUAL)

February 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 4, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLL1920

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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