Factors Influencing Hepatitis B Virus Reactivation in Lymphoma Patients Treated With Rituximab
NCT ID: NCT01311232
Last Updated: 2017-10-27
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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COMPLETED
600 participants
OBSERVATIONAL
2010-11-01
2013-12-01
Brief Summary
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We collect the clinical features and laboratory findings of patients satisfied the inclusion criteria as follows.
1. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) or \\ follicular B-cell lymphoma (FL).
2. Patients who had received at least two cycles of rituximab-CHOP or rituximab-CVP as a primary treatment
3. 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
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* 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
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Case
Patients with HBV reactivation
No interventions assigned to this group
Control
Patients without HBV reactivation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patients who had received at least two cycles of rituximab-CHOP or rituximab-CVP as a primary treatment
3. Patients with a history of previous exposure to HBV
* HBV surface antigen (HBs Ag) positive Or
* HBV core antibody (IgG anti-HBc antibody) positive
4. 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
* 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
Exclusion Criteria
2. patients diagnosed with HIV, HCV or HDV co-infection
3. Patients who had undergone allogenic stem cell transplantation before hepatitis B virus reactivation was documented
15 Years
90 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Won Seog Kim
Professor
Locations
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Queen Mary Hospital
Hing Kong, , China
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
National Cancer Center
Singapore, , Singapore
Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2010-11-035
Identifier Type: -
Identifier Source: org_study_id