The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide (CLL1818)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.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

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2

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:
          • Daniela Pietrasanta
      • Ancona, Italy
      • Ascoli Piceno, Italy
        • Recruiting
        • Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
      • Aviano, Italy
        • Recruiting
        • Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari
        • Contact:
      • Bari, Italy
        • Recruiting
        • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
        • Contact:
      • Bari, Italy
      • Brindisi, Italy
      • Catania, Italy
        • Recruiting
        • Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
        • Contact:
      • Cona, Italy
        • Recruiting
        • Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
        • Contact:
      • Foggia, Italy
        • Recruiting
        • Aou Ospedali Riuniti - Foggia - Uoc Ematologia
        • Contact:
      • Lecce, Italy
        • Recruiting
        • Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
      • Messina, Italy
        • Recruiting
        • Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
      • Napoli, Italy
        • Recruiting
        • Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
        • Contact:
      • Napoli, Italy
        • Recruiting
        • Aou Federico Ii - Napoli - Uoc Ematologia
      • Novara, Italy
        • Recruiting
        • Aou Maggiore Della Carita' Di Novara - Scdu Ematologia
      • Pagani, Italy
        • Recruiting
        • Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
      • Palermo, Italy
        • Recruiting
        • Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
        • Contact:
          • Caterina Patti
      • Pavia, Italy
        • Recruiting
        • Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
        • Contact:
      • Pescara, Italy
        • Recruiting
        • Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
        • Contact:
          • Elsa Pennese
      • Reggio Emilia, Italy
        • Recruiting
        • Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
        • Contact:
      • Rimini, Italy
        • Recruiting
        • Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
        • Contact:
          • Anna Merli
      • Roma, Italy
        • Recruiting
        • Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
        • Contact:
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
        • Contact:
      • Roma, Italy
        • Recruiting
        • Aou Sant'Andrea - Roma - Uoc Ematologia
      • Roma, Italy
      • Roma, Italy
      • San Giovanni Rotondo, Italy
        • Recruiting
        • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
      • Torino, Italy
        • Recruiting
        • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
      • Verona, Italy
        • Recruiting
        • Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
      • Vicenza, Italy
    • (rm)
      • Roma, (rm), Italy
        • Recruiting
        • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
        • Contact:
          • Giuseppe Gentile
        • Principal Investigator:
          • Giuseppe Gentile
        • Sub-Investigator:
          • Alessandra Micozzi

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study group
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.
Drug: Rituximab
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.
Drug: Chemotherapy
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.
Drug: Tenofovir alafenamide
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients presenting hepatitis B virus reactivation
Time Frame: Within 6 months following the start of treatment
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.
Within 6 months following the start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients presenting hepatitis B virus reactivation
Time Frame: After 12 months following the study entry and start of treatment
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
After 12 months following the study entry and start of treatment
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.
Time Frame: After 31 months from study entry
After 31 months from study entry
Percentage of patients in which chemotherapy is delayed due to HBV-reactivation.
Time Frame: After 31 months from study entry
In terms of percentage of patients with a delay of at least 7 days between chemotherapy cycles stratified by DLBCL and chronic lymphoid leukemia.
After 31 months from study entry
Number of patients with DLBCL and with Chronic Lymphoid Leukemia who survive
Time Frame: After 31 months from study entry
After 31 months from study entry
Number of patients experiencing adverse events.
Time Frame: After 31 months from study entry
After 31 months from study entry

Collaborators and Investigators

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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Study Chair: Giuseppe Gentile, Università Sapienza di Roma
  • Study Director: Alessandra Micozzi, Università Sapienza di Roma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 7, 2020

Primary Completion (ANTICIPATED)

January 1, 2024

Study Completion (ANTICIPATED)

July 1, 2024

Study Registration Dates

First Submitted

January 8, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (ACTUAL)

January 15, 2019

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLL1818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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