Chronic Lymphocytic LeukemiaNCT04282811
Observational Study Relapsed or Refractory Chronic Lymphocytic Leukemia Venetoclax-based Regimens Outside Clinical Trials in Italy
An observational study of Chronic Lymphocytic Leukemia and Relapse Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 27 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Relapse Leukemia, Refractory Leukemia
- What is being tested?
- Venetoclax
- How many people
- 321 participants
- Where
- 27 sitesItaly
- Study dates
- 24 Jul 2020to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 June 30th, 2025.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Italy27 sites
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
Cagliari
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
Catania
Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia
Catanzaro
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
Cona, Ferrara
Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia
Cosenza
Aou Careggi - Firenze - Sod Ematologia
Florence
Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
Messina
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan
Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B
Milan
Aou Di Modena - Sc Ematologia
Modena
Aou Maggiore Della Carita' Di Novara - Scdu Ematologia
Novara
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
Palermo
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
Perugia
Aou Pisana - Uo Ematologia Universitaria
Pisa
Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia
Ravenna
Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia
Reggio Calabria
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Reggio Emilia
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
Roma
Ao S. Maria - Terni - Sc Onco Ematologia
Terni
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
Torino
Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi - Uoc Ematologia
Varese
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Verona
About this study
Official title: 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 June 30th, 2025.
Read the 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).
- Being tested
- Venetoclax
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Patients treated with venetoclax-based regimens outside clinical trials in Italy
| Study group | Role | What they receive |
|---|---|---|
| cohort group | Patients who have received at least one dose of venetoclax Receives: Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start24 Jul 2020
- Primary completion31 Jan 2023
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 321 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282811
- Sponsor's protocol ID
- CLL1920
- Status last verified
- Jun 2026
- First submitted
- 21 Feb 2020
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04282811
- Acronym / sponsor ID
- CLL1920
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 321 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort group | – | Drug: VenetoclaxPatients who have received at least one dose of venetoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 June 30th, 2025.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxPatients treated with venetoclax-based regimens outside clinical trials in Italy | Drug | cohort group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia and Relapse Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 27 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.