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

NCT04539119 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-09-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Tenofovir

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.

DRUG

Entecavir

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-03
Primary Completion
2022-09-01
Completion
2024-09-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04539119 on ClinicalTrials.gov