LymphomaPhase 2/3IHBVRLNCT01210287
Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP
A Phase 2/3 study testing nucleoside analog reverse transcriptase inhibitor in people with Lymphoma, run by Fudan University at 2 sites in China.
Trial summary
The aim of this study is to identify the incidence of hepatitis B virus reactivation rate in Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved hepatitis B undergoing RCHOP immuno-chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- nucleoside analog reverse transcriptase inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2010to Aug 2014
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Naive DLBCL or high grade FL patients
- Age range 18-75 years old
- ECOG performance status 0-3
- Life expectancy of more than 3 months
- Adequate organ function
- HBsAg negative/HBcAb positive at baseline
Who cannot join
- Infection of HAV,HCV,HIV
- Pregnant or lactating women
- Serious uncontrolled diseases
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 86-21
About this study
Official title: Incidence of HBV Reactivation in HBsAg Negative/HBcAb Positive Diffuse Large B Cell Lymphoma or High Grade Follicular Lymphoma Patients: A Prospective Study
The aim of this study is to identify the incidence of hepatitis B virus reactivation rate in Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved hepatitis B undergoing RCHOP immuno-chemotherapy.
- Conditions
- Lymphoma
- Being tested
- nucleoside analog reverse transcriptase inhibitor
- Keywords
- hepatitis B virus reactivation, HBsAg negative, HBcAb positive, lymphoma, rituximab
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nucleoside analog reverse transcriptase inhibitorDrug
Also called lamivudine
tablets 100mg qd
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Observation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment. Receives: Drug: nucleoside analog reverse transcriptase inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of HBV reactivation
HBV reactivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN).
Measured: from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP
Secondary outcomes (1)
the outcome of antiviral therapy in HBV-DNA abnormal patients
Once the level of HBV-DNA exceeds the upper limit of normal, antiviral therapy will be given immediately.Liver function and serum HBsAg and HBcAg of these patients will be monitored until six months after the last dosing of RCHOP.
Measured: from the initiation of antiviral thearpy to six months after the last cycle of RCHOP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junning Cao, Fudan University
- Investigators
- Junning Cao, Doctor, Principal investigator, member of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210287
- Sponsor's protocol ID
- 201010HBV
- Acronym
- IHBVRL
- Status last verified
- Jan 2014
- First submitted
- 27 Sep 2010
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of HBV Reactivation in HBsAg Negative/HBcAb Positive Diffuse Large B Cell Lymphoma or High Grade Follicular Lymphoma Patients: A Prospective Study
- ClinicalTrials.gov ID
- NCT01210287
- Acronym / sponsor ID
- IHBVRL / 201010HBV
- Conditions
- Lymphoma
- Keywords
- hepatitis B virus reactivation, HBsAg negative, HBcAb positive, lymphoma, rituximab
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 28 Sep 2010 (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 identify the incidence of hepatitis B virus reactivation rate in Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved hepatitis B undergoing RCHOP immuno-chemotherapy.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | Drug: nucleoside analog reverse transcriptase inhibitorObservation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Naive DLBCL or high grade FL patients
- Age range 18-75 years old
- ECOG performance status 0-3
- Life expectancy of more than 3 months
- Adequate organ function
Key exclusion criteria (3 listed)
- Infection of HAV,HCV,HIV
- Pregnant or lactating women
- Serious uncontrolled diseases
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 |
|---|---|---|
| nucleoside analog reverse transcriptase inhibitorAlso: lamivudinetablets 100mg qd | Drug | Observation |
Primary outcome
incidence of HBV reactivation
Time frame: from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP
HBV reactivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN).
1 secondary outcome
the outcome of antiviral therapy in HBV-DNA abnormal patients
Time frame: from the initiation of antiviral thearpy to six months after the last cycle of RCHOP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
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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.
Junning Cao, Doctor principal investigator
member of Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing nucleoside analog reverse transcriptase inhibitor in people with Lymphoma, run by Fudan University at 2 sites 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 3 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 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of HBV reactivation (time frame: from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP). 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 8 Jan 2014.