AzTrials
AzTrials

Large-B-cell Diffuse LymphomaPhase 2CLL1818NCT03804372

The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide

A Phase 2 study testing Rituximab, Chemotherapy and Tenofovir alafenamide in people with Large-B-cell Diffuse Lymphoma and Chronic Lymphoid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 31 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

In this study, we will evaluate the incidence of hepatitis B virus reactivation within the first 6 months of treatment with rituximab, standard chemotherapy and TAF in patients with diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rituximab, Chemotherapy and Tenofovir alafenamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
31 sitesItaly
Study dates
7 Jul 2020to 22 May 2024
Phase
Phase 2
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

Who may be able to join

  • Signed written informed consent according to ICH/EU/GCP and national local laws.
  • Male/non-pregnant/non-lactating female subjects >18 years old with newly diagnosed DLBCL/Chronic Lymphoid Leukemia who are going to receive treatment with rituximab in combination with chemotherapy.
  • HBsAg positivity, serum HBV-DNA negative or positive (<2000/IU), and normal liver function, including alanine aminotransferase(ALT), aspartate aminotransferase(AST) and bilirubin. (inactive carriers).
  • No previous treatment with antiviral drugs for HBV infection.
  • Patients with satisfactory renal function.

Who cannot join

  • Hepatic insufficiency for any reason
  • History of other liver diseases such as hepatitis C, D, autoimmune hepatitis, primary biliary cirrhosis, Wilsons' disease
  • Positive viral markers, such as IgM antibody to hepatitis A virus, hepatitis C virus, IgG antibody to hepatitis D virus, IgM antibody to hepatitis E virus, or antibody to HIV
  • Pregnant or breastfeeding women
  • Other major systemic diseases, such as active infection, significant cardiac disease, neurological deficit or psychiatric disorder, that the investigators consider being a significant risk
  • Patients with moderate or severe renal failure.
  • Intolerance to any of the components of the therapeutic regimen. Treatment with any investigational medicinal product (unapproved) in the last 30 days.
  • Any other disorder that, in the investigator's opinion, makes the patient ineligible for recruitment or that could interfere in his/her participation or in the conclusion of the study.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Italy31 sites

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

    Alessandria

  • Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica

    Ancona

  • Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia

    Ascoli Piceno

  • Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari

    Aviano

  • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

    Bari

  • Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia

    Bari

  • Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia

    Brindisi

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

    Catania

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

    Cona

  • Aou Ospedali Riuniti - Foggia - Uoc Ematologia

    Foggia

  • Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia

    Lecce

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

    Messina

  • Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo

    Naples

  • Aou Federico Ii - Napoli - Uoc Ematologia

    Naples

  • Aou Maggiore Della Carita' Di Novara - Scdu Ematologia

    Novara

  • Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia

    Pagani

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

    Palermo

  • Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia

    Pavia

  • Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica

    Pescara

  • Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia

    Reggio Emilia

  • Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia

    Rimini

  • Ao San Camillo Forlanini - Roma - Uoc Ematologia E Trapianto Cellule Staminali

    Roma

  • Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali

    Roma

  • Aou Sant'Andrea - Roma - Uoc Ematologia

    Roma

  • Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia

    Roma

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

    Roma

  • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

    Roma

  • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia

    San Giovanni Rotondo

  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino

    Torino

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

    Verona

  • Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

    Vicenza

Other trials in Italy

About this study

Official title: Prospective Study on the Incidence of Hepatitis B Virus Reactivation in Untreated Patients With Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide

In this study, we will evaluate the incidence of hepatitis B virus reactivation within the first 6 months of treatment with rituximab, standard chemotherapy and TAF in patients with diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive.

Read the detailed description

This is a prospective, multicenter, interventional, single arm, evaluating the incidence of hepatitis B virus (HBV) reactivation within the first 6 months treatment period in HBsAg positive patients treated for DLBCL/Chronic Lymphoid Leukemia with Rituximab, standard chemotherapy, and TAF.

Approximate duration of the recruitment period based on the number of patients available The duration of the recruitment period has been estimated at 12 months.

Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy. Then patients will be also observed for further12 months

Being tested
Rituximab, Chemotherapy, Tenofovir alafenamide
Keywords
diffuse Large B-Cell Lymphoma, chronic Lymphoid Leukemia HBsAg-positive, Rituximab, chemotherapy, alafenamide, hepatitis B virus reactivation
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Leukemia, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.

  • ChemotherapyDrug

    Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.

  • Tenofovir alafenamideDrug

    Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.

Study groups in NCT03804372
Study groupRoleWhat they receive
Study groupExperimentalPatients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.
Receives: Drug: Rituximab; Drug: Chemotherapy; Drug: Tenofovir alafenamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients presenting hepatitis B virus reactivation

    Assessment of the percentage of patients presenting HBV reactivation within 6 months following the start of treatment with Rituximab, chemotherapy and TAF in in DLBCL and Chronic Lymphoid Leukemia patients.

    Measured: Within 6 months following the start of treatment

Secondary outcomes (5)

  1. Percentage of patients presenting hepatitis B virus reactivation

    Assessment of the percentage of patients presenting HBV reactivation during and after the 12-month treatment of TAF as a single agent in in DLBCL and Chronic Lymphoid Leukemia patients

    Measured: After 12 months following the study entry and start of treatment

  2. Number of patients stratified by DLBCL and Chronic Lymphoid Leukemia with hepatitis related to the HBV infection or with liver failure during their participation in the study.

    Measured: After 31 months from study entry

  3. Percentage of patients in which chemotherapy is delayed due to HBV-reactivation.

    In terms of percentage of patients with a delay of at least 7 days between chemotherapy cycles stratified by DLBCL and chronic lymphoid leukemia.

    Measured: After 31 months from study entry

  4. Number of patients with DLBCL and with Chronic Lymphoid Leukemia who survive

    Measured: After 31 months from study entry

  5. Number of patients experiencing adverse events.

    Measured: After 31 months from study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start7 Jul 2020
  3. Primary completion22 May 2024
  4. Study completion22 May 2024

Why it stopped: low enrollment rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03804372
Sponsor's protocol ID
CLL1818
Acronym
CLL1818
Status last verified
Feb 2025
First submitted
8 Jan 2019
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Picardi M, Giordano C, Della Pepa R, Pugliese N, Leone A, Delle Cave G, Iula R, Pane F, Gentile G. Regarding "Hepatitis B Surface Antigen Positivity Is an Independent Unfavorable Prognostic Factor in Diffuse Large B-Cell Lymphoma in the Rituximab Era". Oncologist. 2021 Jun;26(6):e1083-e1084. doi: 10.1002/onco.13710. Epub 2021 Feb 24.

    PubMed 33559286

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, Chemotherapy and Tenofovir alafenamide in people with Large-B-cell Diffuse Lymphoma and Chronic Lymphoid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 31 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low enrollment rate). Results are not available in the source record.

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?

Percentage of patients presenting hepatitis B virus reactivation (time frame: Within 6 months following the start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03804372, which also lists 1 linked publication.

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 27 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in