Non-Hodgkin LymphomaPhase 2NCT01914744
Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL
A Phase 2 study testing Entecavir and Lamivudine in people with Non-Hodgkin Lymphoma and Hepatitis B Reactivation, run by Fudan University at 1 site in China.
Trial summary
The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Hodgkin Lymphoma, Hepatitis B Reactivation
- What is being tested?
- Entecavir and Lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Dec 2016
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated NHL suitable for CHOP/R-CHOP treatment
- Age range 18-80 years old
- HBsAg positive with high level of HBV DNA
- Eastern Cooperative Oncology Group performance status 0-2
- Life expectancy of more than 3 months
- Adequate organ function
Who cannot join
- Primary or secondary central nervous system involvement
- With hepatitis C virus infection
- Previous serious cardiac disease
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Pregnant or lactating women
- Serious uncontrolled diseases and intercurrent infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Ye Guo, MD, +86 21 64175590 ext. 8906, pattrick_guo@msn.com
Ye Guo, MD
About this study
Official title: Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Virus Reactivation in Patients With Non-Hodgkin Lymphoma on CHOP/R-CHOP: a Randomized Phase II Study
The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.
Read the detailed description
In china, previous studies showed patients with non-Hodgkin lymphoma (NHL) are likely to have hepatitis B virus (HBV) infection. The risk of HBV reactivation is high when patients were treated with CHOP, especially in combination with rituximab. The aim of this study is to compare entecavir with lamivudine, 2 commonly used anti-virus agents, for preventing the risk of HBV reactivation in patients with NHL on CHOP/R-CHOP.
- Conditions
- Non-Hodgkin Lymphoma, Hepatitis B Reactivation
- Being tested
- Entecavir, Lamivudine
- Keywords
- NHL, HBV, entecavir, lamivudine
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
Also called baraclude
entecavir 0.5 mg/day PO
LamivudineDrug
Also called epivir
lamivudine 100 mg/day PO
| Study group | Role | What they receive |
|---|---|---|
| entecavir | Experimental | entecavir 0.5 mg/day PO Receives: Drug: Entecavir; Drug: Lamivudine |
| lamivudine | Active comparator | lamivudine 100 mg/day PO Receives: Drug: Entecavir; Drug: Lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of HBV reactivation
Defined by increased level of HBV DNA
Measured: 12 months
Secondary outcomes (3)
Incidence rate of hepatitis and HBV reactivation-related hepatitis
Defined by increased level of alanine transaminase
Measured: 6 months
Incidence rate and median time of treatment delay due to hepatitis
Measured by information of treatment delay
Measured: 6 months
Incidence rate and median time of HBV DNA level normalization
Measured by information of HBV DNA level normalization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Guo, Fudan University
- Investigators
- Ye Guo, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914744
- Sponsor's protocol ID
- LMTG 13-03
- Status last verified
- Jul 2013
- First submitted
- 2 Mar 2013
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Virus Reactivation in Patients With Non-Hodgkin Lymphoma on CHOP/R-CHOP: a Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT01914744
- Acronym / sponsor ID
- LMTG 13-03
- Conditions
- Non-Hodgkin Lymphoma, Hepatitis B Reactivation
- Keywords
- NHL, HBV, entecavir, lamivudine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Aug 2013 (estimated)
- 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.
The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.
Detailed description
In china, previous studies showed patients with non-Hodgkin lymphoma (NHL) are likely to have hepatitis B virus (HBV) infection. The risk of HBV reactivation is high when patients were treated with CHOP, especially in combination with rituximab. The aim of this study is to compare entecavir with lamivudine, 2 commonly used anti-virus agents, for preventing the risk of HBV reactivation in patients with NHL on CHOP/R-CHOP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| entecavir | Experimental | Drug: Entecavir, Drug: Lamivudineentecavir 0.5 mg/day PO |
| lamivudine | Active comparator | Drug: Entecavir, Drug: Lamivudinelamivudine 100 mg/day PO |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Previously untreated NHL suitable for CHOP/R-CHOP treatment
- Age range 18-80 years old
- HBsAg positive with high level of HBV DNA
- Eastern Cooperative Oncology Group performance status 0-2
- Life expectancy of more than 3 months
Key exclusion criteria (6 listed)
- Primary or secondary central nervous system involvement
- With hepatitis C virus infection
- Previous serious cardiac disease
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Pregnant or lactating women
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 |
|---|---|---|
| EntecavirAlso: baracludeentecavir 0.5 mg/day PO | Drug | entecavir, lamivudine |
| LamivudineAlso: epivirlamivudine 100 mg/day PO | Drug | entecavir, lamivudine |
Primary outcome
Incidence rate of HBV reactivation
Time frame: 12 months
Defined by increased level of HBV DNA
3 secondary outcomes
Incidence rate of hepatitis and HBV reactivation-related hepatitis
Time frame: 6 months
Incidence rate and median time of treatment delay due to hepatitis
Time frame: 6 months
Incidence rate and median time of HBV DNA level normalization
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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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.
Ye Guo, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Entecavir and Lamivudine in people with Non-Hodgkin Lymphoma and Hepatitis B Reactivation, run by Fudan University 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 6 inclusion and 6 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 2 Aug 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Ye Guo, MD (+86 21 64175590 ext. 8906, pattrick_guo@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of HBV reactivation (time frame: 12 months). 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 2 Aug 2013.