B-cell Lymphoma, HBV
Conditions
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.
Interventions
DRUGTenofovir
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.
DRUGEntecavir
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
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. | — |
| 2-year OS | 2 years after enrollment | Overall survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| Associated factors for successful inhibition of HBV replication | From enrollment to study completion, an maximum of 3 years. | Biomarkers measured in tumor tissues and peripheral blood |
Countries
China
Outcome results
None listed