Chronic Lymphocytic LeukemiaLLC1618NCT03528941
The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia With Ibrutinib
An observational study of Chronic Lymphocytic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 23 sites in Italy.
Trial summary
This observational retrospective study will enroll at least 158 patients affected by Chronic Lymphoid Leukemia (CLL) with previous HBV exposure (HBsAg negative, anti-HBc positive with or without anti-HBs) treated with Ibrutinib single agent according to the IWCLL criteria 2008. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Lamivudine and No prophylaxis
- How many people
- 109 participants
- Where
- 23 sitesItaly
- Study dates
- 28 Nov 2018to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with CLL with previous HBV exposure treated with at least one dose of Ibrutinib.
Who may be able to join
- CLL/small lymphocytic lymphoma (SLL) patients.
- Patients treated with single-agent Ibrutinib (at least one dose) outside interventional clinical trials before January 31, 2019.
- Serology positive with previous HBV/OBI (HBsAg negatives, anti-HBc positives with or without anti-HBs) infection.
- Signed written informed consent, if applicable, indicating study scope and procedure understanding.
Who cannot join
- Patients who did not undergo hepatitis B screening before starting the Ibrutinib therapy.
- Patients affected by CLL treated with Ibrutinib vaccinated against hepatitis B or with serology not compatible with a previous infection.
- Patients affected by HCV, HIV or with other causes of liver disease.
- Patients enrolled in clinical trials including Ibrutinib administered in combination with other drugs.
- Patients positive for active hepatitis B.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Italy23 sites
AOU Consorziale Policlinico - UO Ematologia con Trapianto
Bari
ASST degli Ospedali Civili di Brescia - UO Ematologia
Brescia
AO Brotzu, Presidio Ospedaliero A.Businco - 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 S.Anna - UOC Ematologia e fisiopatologia della coagulazione
Cona, Ferrara
Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia
Cosenza
IRCCS AOU San Martino - UO Ematologia e Trapianti
Genova
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan
Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico - Ematologia
Milan
IRCCS Ospedale San Raffaele - Unità neoplasie linfocitarie B
Milan
Aou Di Modena - Sc Ematologia
Modena
AOU Maggiore della Carità di Novara - SCDU Ematologia
Novara
Fondazione IRCCS Policlinico San Matteo - OU Ematologia
Pavia
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
Pescara
AOU Pisana - UO Ematologia Universitaria
Pisa
AOU Policlinico Tor Vergata - UOC Trapianto cellule staminali
Roma
Fondazione Policlinico Universitario A. Gemelli IRCCS - Area Ematologica
Roma
Policlinico Universitario Campus Bio Medico - UOC Ematologia e Trapianto di cellule staminali
Roma
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
Roma
Aou Senese - Uoc Ematologia E Trapianti
Siena
AOU Città della Salute e della Scienza, Ospedale S.Giovanni Battista Molinette - SC Ematologia
Torino
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Verona
About this study
Official title: Observational Retrospective Multicenter Study Aimed at Evaluating the Incidence of Hepatitis B Reactivation in Patients Affected by Chronic Lymphocytic Leukemia Treated With Ibrutinib
This observational retrospective study will enroll at least 158 patients affected by Chronic Lymphoid Leukemia (CLL) with previous HBV exposure (HBsAg negative, anti-HBc positive with or without anti-HBs) treated with Ibrutinib single agent according to the IWCLL criteria 2008. Patients will be divided into two cohorts, one encompassing patients who received lamivudine and the second one including patients who received no prophylaxis. Each patient will be observed for one year from the first administration of Ibrutinib.
Read the detailed description
This observational retrospective study will enroll at least 158 patients affected by CLL with previous HBV exposure (HBsAg negative, anti HBc positive with or without anti-HBs) treated with Ibrutinib single agent according to the IWCLL criteria 2008. Patients will be divided in two cohorts one encompassing patients receiving lamivudine and the second one including patients who will not be given any prophylaxis. Each patient will be observed for one year from the first administration of Ibrutinib.
The aim of the Study is to evaluate the incidence of HBV reactivation cases in patients affected by CLL treated with Ibrutinib.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Lamivudine, No prophylaxis
- Keywords
- Chronic Lymphocytic Leukemia, Hepatitis B, Ibrutinib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamivudineDrug
Patients who received lamivudine to prevent hepatitis B
No prophylaxisOther
Patients who did not receive any prophylaxis to prevent hepatitis B
| Study group | Role | What they receive |
|---|---|---|
| Lamivudine | Patients who received lamivudine Receives: Drug: Lamivudine | |
| No prophylaxis | Patients who did not receive any prophylaxis Receives: Other: No prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with hepatitis B reactivation
The primary objective of the Study is to evaluate the incidence of HBV reactivation cases in patients affected by CLL treated with Ibrutinib.
Measured: After 12 months from the first administration of Ibrutinib
Secondary outcomes (4)
Rate of patients managed by prophylaxis
number of patients managed by lamivudine prophylaxis
Measured: After 12 months from the first administration of Ibrutinib
Rate of patients undergoing strict follow-up only
number of patients who did not receive any prophylaxis
Measured: After 12 months from the first administration of Ibrutinib
Rate of HBV reactivation according to patient status and prophylaxis
Incidence of HBV reactivation related to patient clinical, biological and therapeutic characteristics, especially in connection with the different incidence of reactivation in patients who received lamivudine prophylaxis versus patients observed with a strict follow-up.
Measured: After 12 months from the first administration of Ibrutinib
Rate of adverse events during ibrutinib treatment
Safety profile in patients who received lamivudine prophylaxis versus patients observed with a strict follow-up
Measured: After 12 months from the first administration of Ibrutinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start28 Nov 2018
- Primary completion26 Mar 2021
- Study completion30 Jun 2021
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Laurenti, Principal investigator, Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528941
- Sponsor's protocol ID
- LLC1618
- Acronym
- LLC1618
- Status last verified
- May 2022
- First submitted
- 7 May 2018
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Multicenter Study Aimed at Evaluating the Incidence of Hepatitis B Reactivation in Patients Affected by Chronic Lymphocytic Leukemia Treated With Ibrutinib
- ClinicalTrials.gov ID
- NCT03528941
- Acronym / sponsor ID
- LLC1618 / LLC1618
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, Hepatitis B, Ibrutinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 May 2018 (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.
This observational retrospective study will enroll at least 158 patients affected by Chronic Lymphoid Leukemia (CLL) with previous HBV exposure (HBsAg negative, anti-HBc positive with or without anti-HBs) treated with Ibrutinib single agent according to the IWCLL criteria 2008. Patients will be divided into two cohorts, one encompassing patients who received lamivudine and the second one including patients who received no prophylaxis. Each patient will be observed for one year from the first administration of Ibrutinib.
Detailed description
This observational retrospective study will enroll at least 158 patients affected by CLL with previous HBV exposure (HBsAg negative, anti HBc positive with or without anti-HBs) treated with Ibrutinib single agent according to the IWCLL criteria 2008. Patients will be divided in two cohorts one encompassing patients receiving lamivudine and the second one including patients who will not be given any prophylaxis. Each patient will be observed for one year from the first administration of Ibrutinib.
The aim of the Study is to evaluate the incidence of HBV reactivation cases in patients affected by CLL treated with Ibrutinib.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamivudine | – | Drug: LamivudinePatients who received lamivudine |
| No prophylaxis | – | Other: No prophylaxisPatients who did not receive any prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CLL with previous HBV exposure treated with at least one dose of Ibrutinib.
Key inclusion criteria (4 listed)
- CLL/small lymphocytic lymphoma (SLL) patients.
- Patients treated with single-agent Ibrutinib (at least one dose) outside interventional clinical trials before January 31, 2019.
- Serology positive with previous HBV/OBI (HBsAg negatives, anti-HBc positives with or without anti-HBs) infection.
- Signed written informed consent, if applicable, indicating study scope and procedure understanding.
Key exclusion criteria (5 listed)
- Patients who did not undergo hepatitis B screening before starting the Ibrutinib therapy.
- Patients affected by CLL treated with Ibrutinib vaccinated against hepatitis B or with serology not compatible with a previous infection.
- Patients affected by HCV, HIV or with other causes of liver disease.
- Patients enrolled in clinical trials including Ibrutinib administered in combination with other drugs.
- Patients positive for active hepatitis B.
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 |
|---|---|---|
| LamivudinePatients who received lamivudine to prevent hepatitis B | Drug | Lamivudine |
| No prophylaxisPatients who did not receive any prophylaxis to prevent hepatitis B | Other | No prophylaxis |
Primary outcome
Number of patients with hepatitis B reactivation
Time frame: After 12 months from the first administration of Ibrutinib
The primary objective of the Study is to evaluate the incidence of HBV reactivation cases in patients affected by CLL treated with Ibrutinib.
4 secondary outcomes
Rate of patients managed by prophylaxis
Time frame: After 12 months from the first administration of Ibrutinib
Rate of patients undergoing strict follow-up only
Time frame: After 12 months from the first administration of Ibrutinib
Rate of HBV reactivation according to patient status and prophylaxis
Time frame: After 12 months from the first administration of Ibrutinib
Rate of adverse events during ibrutinib treatment
Time frame: After 12 months from the first administration of Ibrutinib
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- GIMEMA Foundation websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Lymphocytic Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
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.
Luca Laurenti principal investigator
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma
23 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, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 23 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with hepatitis B reactivation (time frame: After 12 months from the first administration of Ibrutinib). 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 12 May 2022.