Patients With Diffuse Large B-cell Lymphoma or Follicular LymphomaNCT01311232
Factors Influencing Hepatitis B Virus Reactivation in Lymphoma Patients Treated With Rituximab
An observational study of Patients With Diffuse Large B-cell Lymphoma or Follicular Lymphoma and Patients Treated With Rituximab-CHOP or Rituximab-CVP, run by Samsung Medical Center at 4 sites in 4 countries.
Trial summary
This study is a retrospective analysis to identify factors influencing hepatitis B virus reactivation in patients treated with rituximab containing chemotherapy. Rituximab monoclonal antibody targeting CD20 induces B-cell depletion resulting in prolonged immune suppression. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Patients With Diffuse Large B-cell Lymphoma or Follicular Lymphoma, Patients Treated With Rituximab-CHOP or Rituximab-CVP
- How many people
- 600 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Nov 2010to 1 Dec 2013
- Phase
- Observational
- 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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with hepatitis B virus positivity and treated with rituximab-containing chemotherapy to treat their disease, diffuse large B-cell lymphoma or follicular lymphoma
Who may be able to join
- Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) or follicular B-cell lymphoma (FL).
- Patients who had received at least two cycles of rituximab-CHOP or rituximab-CVP as a primary treatment
- Patients with a history of previous exposure to HBV
- HBV surface antigen (HBs Ag) positive Or
- HBV core antibody (IgG anti-HBc antibody) positive
- Patients with documented HBV reactivation (definite or presumptive) occurring during treatment (at least two cycles of R-CHOP or R-CVP) or within 12 months after the last dose of rituximab
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- Definitive HBV reactivation
- Elevation of serum HBV DNA level >1 log IU/mL from baseline or absolute increase of HBV DNA by 6 log10 IU/mL in HBsAg positive patients
- Presumptive HBV reactivation - Increase of ALT (≥3x baseline value or absolute value of ≥100 U/L) and positive conversion of HBs Ag in previously HBsAg-negative patients
Who cannot join
- Patients who had received chemotherapy other than R-CHOP or R-CVP after diagnosis
- patients diagnosed with HIV, HCV or HDV co-infection
- Patients who had undergone allogenic stem cell transplantation before hepatitis B virus reactivation was documented
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Hepatitis B Virus Reactivation in Asian Patients Treated With Rituximab-containing Treatment
This study is a retrospective analysis to identify factors influencing hepatitis B virus reactivation in patients treated with rituximab containing chemotherapy. Rituximab monoclonal antibody targeting CD20 induces B-cell depletion resulting in prolonged immune suppression. This leads to frequent reactivation of patients with a previous history of exposure to HBV or HBV carrier.
We collect the clinical features and laboratory findings of patients satisfied the inclusion criteria as follows.
Read more
- Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) or \ follicular B-cell lymphoma (FL).
- Patients who had received at least two cycles of rituximab-CHOP or rituximab-CVP as a primary treatment
- Patients with a history of previous exposure to HBV
- HBV surface antigen (HBs Ag) positive Or
- HBV core antibody (IgG anti-HBc antibody) positive
Then, we compare the HBV reactivation group with the control group (HBV reactivation does not happen) to find factors influencing HBV reactivation.
Read the detailed description
Description of factors associated with Hepatitis B virus reactivation:
- Laboratory parameters defining HBV status/activity at time of treatment initiation
- Lymphoma stage at rituximab treatment initiation (Ann Arbor, B-symptoms, bone marrow involvement, IPI, ECOG-score, LDH)
- Immunochemotherapy regimen (treatment line, rituximab dose and cycle)
- Disease status at time of HBV reactivation
- Antiviral prophylaxis (medication, dose, duration at time at time of reactivation)
- Patient demographics (age, gender, residence, ethnic origin, smoking status, alcohol consumption and occupation)
Time to Hepatitis B virus reactivation
- The time from start of rituximab-containing immunochemotherapy until first evidence of HBV reactivation meeting the criteria
- Description of prophylaxis and treatment with antiviral medication HBV vaccination Time of initiation of antiviral therapy of prophylaxis relating to clinical or laboratory signs of possible HBV reactivation Anti-viral medication used in prophylaxis or therapy
- Description of outcomes Outcomes of the HBV reactivation Outcomes of the rituximab-containing immunochemotherapy Demographics and previous infection history: Age, gender, nationality, race, social history, past medical history
- Parameters associated with lymphomas: Ann Arbor stage, number of extranodal involvement, serum LDH, serum β2-microglobulin, ECOG performance status, presence of B symptoms, International Prognostic Index, bone marrow invasion
- Laboratory parameters associated with hepatitis B virus: hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti- HBs), hepatitis B e antigen (HBeAg), hepatitis B core antibody (anti-HBc), hepatitis B e antibody (anti-HBe), serum HBV DNA
- Lymphoma treatment history:
Line of treatment (first line, second line), rituximab and chemotherapy administration (dose, schedule), start date, last treatment date
- Prophylaxis or treatment against HBV reactivation: antiviral drug (dose, schedule, duration)
- Hepatitis B virus reactivation: onset, serologic markers, outcome
- Conditions
- Patients With Diffuse Large B-cell Lymphoma or Follicular Lymphoma, Patients Treated With Rituximab-CHOP or Rituximab-CVP
- Keywords
- rituximab, lymphoma, hepatitis B virus
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients with HBV reactivation | |
| Control | Patients without HBV reactivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis B virus reactivation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study start1 Nov 2010
- Primary completion1 Dec 2012
- Study completion1 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Diffuse Large B-cell Lymphoma or Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311232
- Sponsor's protocol ID
- 2010-11-035
- Status last verified
- Oct 2017
- First submitted
- 6 Mar 2011
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis B Virus Reactivation in Asian Patients Treated With Rituximab-containing Treatment
- ClinicalTrials.gov ID
- NCT01311232
- Acronym / sponsor ID
- 2010-11-035
- Conditions
- Patients With Diffuse Large B-cell Lymphoma or Follicular Lymphoma, Patients Treated With Rituximab-CHOP or Rituximab-CVP
- Keywords
- rituximab, lymphoma, hepatitis B virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2010 (actual)
- Primary completion
- 1 Dec 2012 (actual)
- Study completion
- 1 Dec 2013 (actual)
- First posted
- 9 Mar 2011 (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.
This study is a retrospective analysis to identify factors influencing hepatitis B virus reactivation in patients treated with rituximab containing chemotherapy. Rituximab monoclonal antibody targeting CD20 induces B-cell depletion resulting in prolonged immune suppression. This leads to frequent reactivation of patients with a previous history of exposure to HBV or HBV carrier.
We collect the clinical features and laboratory findings of patients satisfied the inclusion criteria as follows.
- Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) or \ follicular B-cell lymphoma (FL).
- Patients who had received at least two cycles of rituximab-CHOP or rituximab-CVP as a primary treatment
- Patients with a history of previous exposure to HBV
- HBV surface antigen (HBs Ag) positive Or
- HBV core antibody (IgG anti-HBc antibody) positive
Then, we compare the HBV reactivation group with the control group (HBV reactivation does not happen) to find factors influencing HBV reactivation.
Detailed description
Description of factors associated with Hepatitis B virus reactivation:
- Laboratory parameters defining HBV status/activity at time of treatment initiation
- Lymphoma stage at rituximab treatment initiation (Ann Arbor, B-symptoms, bone marrow involvement, IPI, ECOG-score, LDH)
- Immunochemotherapy regimen (treatment line, rituximab dose and cycle)
- Disease status at time of HBV reactivation
- Antiviral prophylaxis (medication, dose, duration at time at time of reactivation)
- Patient demographics (age, gender, residence, ethnic origin, smoking status, alcohol consumption and occupation)
Time to Hepatitis B virus reactivation
- The time from start of rituximab-containing immunochemotherapy until first evidence of HBV reactivation meeting the criteria
- Description of prophylaxis and treatment with antiviral medication HBV vaccination Time of initiation of antiviral therapy of prophylaxis relating to clinical or laboratory signs of possible HBV reactivation Anti-viral medication used in prophylaxis or therapy
- Description of outcomes Outcomes of the HBV reactivation Outcomes of the rituximab-containing immunochemotherapy Demographics and previous infection history: Age, gender, nationality, race, social history, past medical history
- Parameters associated with lymphomas: Ann Arbor stage, number of extranodal involvement, serum LDH, serum β2-microglobulin, ECOG performance status, presence of B symptoms, International Prognostic Index, bone marrow invasion
- Laboratory parameters associated with hepatitis B virus: hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti- HBs), hepatitis B e antigen (HBeAg), hepatitis B core antibody (anti-HBc), hepatitis B e antibody (anti-HBe), serum HBV DNA
- Lymphoma treatment history:
Line of treatment (first line, second line), rituximab and chemotherapy administration (dose, schedule), start date, last treatment date
- Prophylaxis or treatment against HBV reactivation: antiviral drug (dose, schedule, duration)
- Hepatitis B virus reactivation: onset, serologic markers, outcome
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Patients with HBV reactivation |
| Control | – | –Patients without HBV reactivation |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hepatitis B virus positivity and treated with rituximab-containing chemotherapy to treat their disease, diffuse large B-cell lymphoma or follicular lymphoma
Key inclusion criteria (9 listed)
- Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) or follicular B-cell lymphoma (FL).
- Patients who had received at least two cycles of rituximab-CHOP or rituximab-CVP as a primary treatment
- Patients with a history of previous exposure to HBV
- Patients with documented HBV reactivation (definite or presumptive) occurring during treatment (at least two cycles of R-CHOP or R-CVP) or within 12 months after the last dose of rituximab
Key exclusion criteria (3 listed)
- Patients who had received chemotherapy other than R-CHOP or R-CVP after diagnosis
- patients diagnosed with HIV, HCV or HDV co-infection
- Patients who had undergone allogenic stem cell transplantation before hepatitis B virus reactivation was documented
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hepatitis B virus reactivation
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Diffuse Large B-cell Lymphoma or Follicular Lymphoma and Patients Treated With Rituximab-CHOP or Rituximab-CVP, run by Samsung Medical Center at 4 sites in 4 countries.
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 9 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: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China, Malaysia, Singapore, South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hepatitis B virus reactivation (time frame: one year). 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 27 Oct 2017; AzTrials last refreshed its copy on 8 Nov 2026.