Entecavir and Tenofovir Versus Entecavir in Lymphoma Patients With Positive HBV DNA

Ruijin Hospital120 enrolled

Overview

This is a prospective, single-center, open-label, randomized controlled trial aimed to evaluate the efficacy and safety of entecavir and tenofovir versus entecavir alone in the antiviral treatment of HBV DNA positive B-cell lymphoma patients. This study plans to enroll about 120 participants in total. Recruitment will last for 2 years. The study visit will take place on the first day of each cycle of therapy until the end of the treatment. Participants who meet the inclusion/exclusion criteria were randomly assigned to receive entecavir and tenofovir or entecavir alone after signing the informed consent. HBV DNA will be measured before each cycle of chemotherapy or immunotherapy. When the copy count of HBV DNA drops below 1\*10\^3/L, entecavir single agent will be given orally, until one year after the cycle of therapy. Treatment response will be evaluated routinely after chemotherapy or immunotherapy. Within 2 years after the last participant is enrolled, participants' survival information will collected by telephone and/or clinical visit every 3 months after the last visit (i.e. date and cause of death, subsequent cancer treatment, etc.), if there is no withdrawal of the informed consent form.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

B-cell Lymphoma HBV

Interventions

TenofovirDRUG

Participants will be given tenofovir 300mg (1 capsule) qd po two weeks before the first cycle of treatment. HBV DNA will be measured before each cycle of chemotherapy or immunotherapy. Tenofovir will be given until the copy count of HBV DNA drops below 1\*10\^3/L.

EntecavirDRUG

Participants will be given entecavir 0.5 mg (1 capsule) qd po from two weeks before the first cycle of treatment until one year after the end of treatment. HBV DNA will be measured before each cycle of chemotherapy or immunotherapy. Entecavir will be given until one year after the end of treatment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Treatment-naive, pathologically confirmed diagnosis of B-cell lymphomas with the viral load of HBV DNA\>1\*10\^3/L * Age≥18 years old * Measurable lesions in radiographic images, defined as at least one well-defined lesions/knots, with both the long diameter and the short diameter≥1.5cm * Life expectancy of at least 3 months according to researchers' judgement * Written informed consent must be provided by participants or their legal representatives prior to any research examination or procedure Exclusion Criteria: * Creatine\<50mL/min * Any medical condition that may affect the conduction of this study according to researchers' judgement

Outcomes

Primary Outcomes

The rate of successful HBV replication inhibition at cycle 2

The rate of participants that the copy count of HBV DNA is lower than 1\*10\^3/L.

Time frame: At the start of cycle 2 (each cycle is 21-28 days)

Secondary Outcomes

Time to successful HBV replication inhibition

The time needed to lower the copy count of HBV DNA to 1\*10\^3/L

Time frame: During the intervention

2-year PFS

Progression free survival

Time frame: 2 years after enrollment

2-year OS

Overall survival

Time frame: 2 years after enrollment

Complete response rate

Time frame: After the completion of first-line chemotherapy, an average of 4 months from enrollment

The incidence of adverse events

Time frame: From enrollment to study completion, an maximum of 3 years.