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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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B-cell Lymphoma, HBV

Intervention / Treatment
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* Drug: Tenofovir
* Drug: Entecavir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Entecavir and Tenofovir<br> | Drug: Tenofovir<br>* 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.<br>Drug: Entecavir<br>* 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.<br>|
| Active Comparator: Entecavir<br> | Drug: Entecavir<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 2-year PFS | Progression free survival | 2 years after enrollment | 
| 2-year OS | Overall survival | 2 years after enrollment | 
| 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. |