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Status unknownNCT01210287IHBVRLUpdated Jan 8, 2014

Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP

A Phase 2/3 interventional study of nucleoside analog reverse transcriptase inhibitor in Lymphoma, sponsored by Fudan University. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-01-08.

Sponsored by Fudan University · Phase 2/3 and Interventional

The sponsor has not verified this record recently (last verified Jan 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
110
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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.

02

Conditions studied

  • Lymphoma

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Keywords

  • hepatitis B virus reactivation
  • HBsAg negative
  • HBcAb positive
  • lymphoma
  • rituximab
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 110 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

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Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Infection of HAV,HCV,HIV
  • Pregnant or lactating women
  • Serious uncontrolled diseases
05

Study design

Phase
Phase 2 / Phase 3
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • No intervention
    Observation

    Observation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment.

    Drug: nucleoside analog reverse transcriptase inhibitor

Interventions

  • Drugnucleoside analog reverse transcriptase inhibitor

    tablets 100mg qd

    Also known as: lamivudine

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What researchers measure

Primary outcomes

  1. incidence of HBV reactivation

    HBV reactivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN).

    Time frame: 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.

    Time frame: from the initiation of antiviral thearpy to six months after the last cycle of RCHOP

07

Study locations

2 sites
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
  • Fudan University Cancer Hospital
    Shanghai, Shanghai 86-21, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01210287
Lead sponsor
Fudan University
Responsible party
Junning Cao (Vice Director of the department of Medical Oncology, Fudan University Cancer Center, Fudan University) — Principal investigator
First posted
Sep 28, 2010
Start date
Oct 2010
Primary completion
Aug 2014 (estimated)
Completion
Aug 2014 (estimated)
Last update
Jan 8, 2014

Study contacts

Junning Cao, Doctor
principal investigator · member of Fudan University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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