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Italian study tracks how venetoclax works for CLL patients in everyday practice

NCT ID NCT04282811

Knowledge-focused Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study follows 321 Italian patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who are treated with venetoclax-based regimens outside of clinical trials. The goal is to describe their clinical features and outcomes, such as how long they live without the disease worsening. By collecting real-world data from March 2016 to June 2025, researchers hope to better understand the effectiveness and safety of venetoclax in routine care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Venetoclax
What this could lead to
If successful, this study could provide real-world evidence on how well venetoclax works for CLL patients outside of clinical trials, potentially guiding better treatment decisions.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection and other factors. It does not test a new treatment but observes existing ones.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 321 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. 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

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia leukemia refractory hematologic cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukemia Refractory leukemia Relapse leukemia

Contacts and locations

Locations

  • 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

  • Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia

    Cosenza, Italy

  • Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo

    Perugia, Italy

  • Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia

    Messina, Italy

  • Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo

    Palermo, Italy

  • Ao S. Maria - Terni - Sc Onco Ematologia

    Terni, Italy

  • Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia

    Alessandria, Italy

  • Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione

    Cona, Ferrara, Italy

  • Aou Careggi - Firenze - Sod Ematologia

    Florence, 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

  • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

    Bari, Italy

  • Aou Di Modena - Sc Ematologia

    Modena, Italy

  • Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia

    Verona, Italy

  • Aou Maggiore Della Carita' Di Novara - Scdu Ematologia

    Novara, Italy

  • Aou Pisana - Uo Ematologia Universitaria

    Pisa, Italy

  • Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi - Uoc Ematologia

    Varese, Italy

  • Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia

    Milan, 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

  • Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania

    Catania, Italy

  • Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora

    Milan, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

    Roma, Italy

  • Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia

    Reggio Calabria, Italy

  • Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B

    Milan, Italy

  • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia

    Roma, Italy

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