Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Infections

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Hepatitis A

Hepatitis

Hepatitis B

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Large B-Cell, Diffuse

Virus Diseases

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Communicable Diseases

Blood-Borne Infections

Hepadnaviridae Infections

DNA Virus Infections

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Herpes Simiae (B Virus)

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Rituximab

Tenofovir

Antineoplastic Agents, Immunological

Immunologic Factors

Antiviral Agents

Reverse Transcriptase Inhibitors

Enzyme Inhibitors

Anti-HIV Agents

Anti-Retroviral Agents

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 All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.

Chemotherapy

Tenofovir alafenamide

Paola Fazi

Enrico Crea

Giuseppe Gentile

Alessandra Micozzi

Daniela Pietrasanta

Guido Gini

Piero Galieni

Emanuela Chimienti

Francesco C Albano

Attilio Guarini

Domenico Pastore

Francesco Di Raimondo

Antonio Cuneo

Vincenza Fernanda Fesce

Nicola Di Renzo

Donato Mannina

Felicetto Ferrara

Fabrizio Pane

Gianluca Gaidano

Catello Califano

Caterina Patti

Luca U Arcaini

Elsa Pennese

Fiorella Ilariucci

Anna Merli

Roberta Battistini

Maria Cantonetti

Agostino Tafuri

Paolo De Fabritiis

Luca Laurenti

Nicola Cascavilla

Marta Coscia

Carlo Visco

Maria Chiara Tisi

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.

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

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

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

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.

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

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

Gruppo Italiano Malattie EMatologiche dell'Adulto

Lymphoma, Follicular

Follicular Lymphoma

Lamivudine

Observation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment.

nucleoside analog reverse transcriptase inhibitor

Junning Cao, Doctor

The aim of this study is to identify the incidence of hepatitis B virus reactivation rate in Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved hepatitis B undergoing RCHOP immuno-chemotherapy.

Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP

Incidence of HBV Reactivation in HBsAg Negative/HBcAb Positive Diffuse Large B Cell Lymphoma or High Grade Follicular Lymphoma Patients: A Prospective Study

HBV reactivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN).

Once the level of HBV-DNA exceeds the upper limit of normal, antiviral therapy will be given immediately.Liver function and serum HBsAg and HBcAg of these patients will be monitored until six months after the last dosing of RCHOP.

Fudan University

Vice Director of the department of Medical Oncology, Fudan University Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide	NCT03804372	Large-B-cell Di... Chronic Lymphoi...	Rituximab Chemotherapy Tenofovir alafe...	18 Years -	Gruppo Italiano Malattie EMatologiche dell'Adulto
The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide	NCT03804372	Large-B-cell Di... Chronic Lymphoi...	Rituximab Chemotherapy Tenofovir alafe...	18 Years -	Gruppo Italiano Malattie EMatologiche dell'Adulto
Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP	NCT01210287	Lymphoma	nucleoside anal...	18 Years - 75 Years	Fudan University

Spots Global Cancer Trial Database for hepatitis b virus reactivation