Entecavir and Tenofovir Versus Entecavir in Lymphoma Patients With Positive HBV DNA
NCT ID: NCT04539119
Last Updated: 2020-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2020-07-03
2024-09-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Entecavir and Tenofovir
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.
Entecavir
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Any medical condition that may affect the conduction of this study according to researchers' judgement
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
First Deputy Director of Shanghai Institute of Hematology
Locations
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Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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EnTe-HBV
Identifier Type: -
Identifier Source: org_study_id
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