Factors Influencing Hepatitis B Virus Reactivation in Lymphoma Patients Treated With Rituximab

October 25, 2017 updated by: Won Seog Kim, Samsung Medical Center

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.

  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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hing Kong, China
        • Queen Mary Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Samsung Medical Center
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Hospital Kuala Lumpur
  • Singapore
      • Singapore, Singapore
        • National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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 documented

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Case
Patients with HBV reactivation
Control
Patients without HBV reactivation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hepatitis B virus reactivation
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 6, 2011

First Submitted That Met QC Criteria

March 6, 2011

First Posted (Estimate)

March 9, 2011

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-11-035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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