B-cell LymphomaPhase 3NCT04539119
Entecavir and Tenofovir Versus Entecavir in Lymphoma Patients With Positive HBV DNA
A Phase 3 study testing Tenofovir and Entecavir in people with B-cell Lymphoma and HBV, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Lymphoma, HBV
- What is being tested?
- Tenofovir and Entecavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2020to 1 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Creatine<50mL/min
- Any medical condition that may affect the conduction of this study according to researchers' judgement
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Weili Zhao, M.D. and Ph.D, 021-64370045, zwl_trial@163.com
About this study
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
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.
Read more
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.
- Conditions
- B-cell Lymphoma, HBV
- Being tested
- Tenofovir, Entecavir
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenofovirDrug
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.
EntecavirDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Entecavir and Tenofovir | Experimental | Not described Receives: Drug: Tenofovir; Drug: Entecavir |
| Entecavir | Active comparator | Not described Receives: Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the start of cycle 2 (each cycle is 21-28 days)
Secondary outcomes (5)
Time to successful HBV replication inhibition
The time needed to lower the copy count of HBV DNA to 1*10^3/L
Measured: During the intervention
2-year PFS
Progression free survival
Measured: 2 years after enrollment
2-year OS
Overall survival
Measured: 2 years after enrollment
Complete response rate
Measured: After the completion of first-line chemotherapy, an average of 4 months from enrollment
The incidence of adverse events
Measured: From enrollment to study completion, an maximum of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start3 Jul 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539119
- Sponsor's protocol ID
- EnTe-HBV
- Status last verified
- Sep 2020
- First submitted
- 28 Aug 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04539119
- Acronym / sponsor ID
- EnTe-HBV
- Conditions
- B-cell Lymphoma, HBV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entecavir and Tenofovir | Experimental | Drug: Tenofovir, Drug: Entecavir |
| Entecavir | Active comparator | Drug: Entecavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Creatine<50mL/min
- Any medical condition that may affect the conduction of this study according to researchers' judgement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenofovirParticipants 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. | Drug | Entecavir and Tenofovir |
| EntecavirParticipants 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. | Drug | Entecavir, Entecavir and Tenofovir |
Primary outcome
The rate of successful HBV replication inhibition at cycle 2
Time frame: 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.
5 secondary outcomes
Time to successful HBV replication inhibition
Time frame: During the intervention
2-year PFS
Time frame: 2 years after enrollment
2-year OS
Time frame: 2 years after enrollment
Complete response rate
Time frame: After the completion of first-line chemotherapy, an average of 4 months from enrollment
The incidence of adverse events
Time frame: From enrollment to study completion, an maximum of 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenofovir and Entecavir in people with B-cell Lymphoma and HBV, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of successful HBV replication inhibition at cycle 2 (time frame: At the start of cycle 2 (each cycle is 21-28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.