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

B-cell Lymphoma Clinical Trial

Official title:

A Comparative Study of the Efficacy and Safety of Entecavir and Tenofovir Versus Entecavir Alone in the Treatment of Hepatitis B DNA-positive Patients With Lymphomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04539119
• Other study ID #: EnTe-HBV
• Status: Recruiting
• Phase: Phase 3
• Start date: July 3, 2020
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2020
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• B-cell Lymphoma
• HBV
• Lymphoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Associated factors for successful inhibition of HBV replication	Biomarkers measured in tumor tissues and peripheral blood	From enrollment to study completion, an maximum of 3 years.
Primary	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.	At the start of cycle 2 (each cycle is 21-28 days)
Secondary	Time to successful HBV replication inhibition	The time needed to lower the copy count of HBV DNA to 1*10^3/L	During the intervention
Secondary	2-year PFS	Progression free survival	2 years after enrollment
Secondary	2-year OS	Overall survival	2 years after enrollment
Secondary	Complete response rate		After the completion of first-line chemotherapy, an average of 4 months from enrollment
Secondary	The incidence of adverse events		From enrollment to study completion, an maximum of 3 years.