Clinical trial NCT04539119: Entecavir and Tenofovir Versus Entecavir in Lymphoma Patients With Positive HBV DNA
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: B-cell Lymphoma
HBV
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The rate of successful HBV replication inhibition at cycle 2
timeFrame: At the start of cycle 2 (each cycle is 21-28 days)
Secondary outcomes:
measure: Time to successful HBV replication inhibition
timeFrame: During the intervention
measure: 2-year PFS
timeFrame: 2 years after enrollment
measure: 2-year OS
timeFrame: 2 years after enrollment
measure: Complete response rate
timeFrame: After the completion of first-line chemotherapy, an average of 4 months from enrollment
measure: The incidence of adverse events
timeFrame: From enrollment to study completion, an maximum of 3 years.
Other outcomes:
measure: Associated factors for successful inhibition of HBV replication
timeFrame: From enrollment to study completion, an maximum of 3 years.
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
Study officials:
References: