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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir and Tenofovir | Experimental |
| |
| Entecavir | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir | Drug | 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. |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| C413685 | entecavir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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|
| Entecavir | Drug | 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. |
|
| 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. |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |