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

Phase 3

Recruiting

• Conditions: B-cell Lymphoma; HBV
• Interventions: Drug: Tenofovir; Drug: Entecavir

• Registration Number: NCT04539119
• Lead Sponsor: Ruijin Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-03
• Study First Submitted: 2020-08-28
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-02
• Study First Posted: 2020-09-04
• Last Update Posted: 2020-09-04
• Primary Completion: 2022-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entecavir and Tenofovir	Tenofovir	-
Entecavir	Entecavir	-
Entecavir and Tenofovir	Entecavir	-

Primary Outcome Measures

Name	Time	Method
The rate of successful HBV replication inhibition at cycle 2	At the start of cycle 2 (each cycle is 21-28 days)	The rate of participants that the copy count of HBV DNA is lower than 1\*10\^3/L.

Secondary Outcome Measures

Name	Time	Method
Time to successful HBV replication inhibition	During the intervention	The time needed to lower the copy count of HBV DNA to 1\*10\^3/L
2-year PFS	2 years after enrollment	Progression free survival
2-year OS	2 years after enrollment	Overall survival
Complete response rate	After the completion of first-line chemotherapy, an average of 4 months from enrollment
The incidence of adverse events	From enrollment to study completion, an maximum of 3 years.

Trial Locations

Locations (1)

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China