Clinical trial · Observational
Factors Influencing Hepatitis B Virus Reactivation in Lymphoma Patients Treated With Rituximab
Hepatitis B Virus Reactivation in Asian Patients Treated With Rituximab-containing Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients Treated With Rituximab-CHOP or Rituximab-CVP | — | UNRESOLVED | — |
| Patients With Diffuse Large B-cell Lymphoma or Follicular Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Case
- description
- Patients with HBV reactivation
- label
- Control
- description
- Patients without HBV reactivation
Primary outcomes (1)
- measure
- Hepatitis B virus reactivation
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria
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
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:
1. Patients who had received chemotherapy other than R-CHOP or R-CVP after diagnosis
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 documentedReferences
Publications (0)
Data not yet available