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

NCT03804372 | Terminated Phase 2

• 1 other identifier: CLL1818
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 31

Brief 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.

Conditions

Large-B-cell Diffuse Lymphoma; Chronic Lymphoid Leukemia

Keywords

diffuse Large B-Cell Lymphoma; chronic Lymphoid Leukemia HBsAg-positive; Rituximab; chemotherapy; alafenamide; hepatitis B virus reactivation

Outcome Measures

Primary Outcomes (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.

  Within 6 months following the start of treatment

Secondary Outcomes (5)

• Percentage of patients presenting hepatitis B virus reactivation

  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.

  After 31 months from study entry

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

  After 31 months from study entry

• Number of patients with DLBCL and with Chronic Lymphoid Leukemia who survive

  After 31 months from study entry

• Number of patients experiencing adverse events.

  After 31 months from study entry

Study Arms (1)

Study group

EXPERIMENTAL

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 All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.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

Interventions

Rituximab DRUG

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 All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.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

Chemotherapy DRUG

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 group

Tenofovir alafenamide DRUG

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 group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (31)

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

Alessandria, Italy

Location

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

Ancona, Italy

Location

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

Ascoli Piceno, Italy

Location

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

Aviano, Italy

Location

Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

Bari, Italy

Location

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

Bari, Italy

Location

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

Brindisi, Italy

Location

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

Catania, Italy

Location

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

Cona, Italy

Location

Aou Ospedali Riuniti - Foggia - Uoc Ematologia

Foggia, Italy

Location

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

Lecce, Italy

Location

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

Messina, Italy

Location

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

Napoli, Italy

Location

Aou Federico Ii - Napoli - Uoc Ematologia

Napoli, Italy

Location

Aou Maggiore Della Carita' Di Novara - Scdu Ematologia

Novara, Italy

Location

Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia

Pagani, Italy

Location

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

Palermo, Italy

Location

Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia

Pavia, Italy

Location

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

Pescara, Italy

Location

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

Reggio Emilia, Italy

Location

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

Rimini, Italy

Location

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

Roma, Italy

Location

Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali

Roma, Italy

Location

Aou Sant'Andrea - Roma - Uoc Ematologia

Roma, Italy

Location

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

Roma, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

Roma, Italy

Location

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

Roma, Italy

Location

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

San Giovanni Rotondo, Italy

Location

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

Torino, Italy

Location

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

Verona, Italy

Location

Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

Vicenza, Italy

Location

Related Publications (1)

• 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.

  PMID: 33559286 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Leukemia, B-Cell

Interventions

Rituximab; Drug Therapy; tenofovir alafenamide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Giuseppe Gentile

  Università Sapienza di Roma

  STUDY CHAIR

• Alessandra Micozzi

  Università Sapienza di Roma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 15, 2019
• Study Start: July 7, 2020
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (31)