Clinical trial · Interventional
Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP
Incidence of HBV Reactivation in HBsAg Negative/HBcAb Positive Diffuse Large B Cell Lymphoma or High Grade Follicular Lymphoma Patients: A Prospective Study
NCT01210287CI-TRIAL-00013353IHBVRLunknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nucleoside analog reverse transcriptase inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- Observation
- description
- Observation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment.
- interventionNames
- Drug: nucleoside analog reverse transcriptase inhibitor
Primary outcomes (1)
- measure
- incidence of HBV reactivation
- timeFrame
- from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP
- description
- HBV reactivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN).
Secondary outcomes (1)
- measure
- the outcome of antiviral therapy in HBV-DNA abnormal patients
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Infection of HAV,HCV,HIV * Pregnant or lactating women * Serious uncontrolled diseases
References
Publications (0)
Data not yet available
No reference posted for this study.