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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Samsung Medical Center.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center Identifier:
First received: March 6, 2011
Last updated: January 12, 2013
Last verified: January 2013

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.

Patients With Diffuse Large B-cell Lymphoma or Follicular Lymphoma
Patients Treated With Rituximab-CHOP or Rituximab-CVP

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Hepatitis B Virus Reactivation in Asian Patients Treated With Rituximab-containing Treatment

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Hepatitis B virus reactivation [ Time Frame: one year ]

Estimated Enrollment: 600
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Patients with HBV reactivation
Patients without HBV reactivation

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


Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
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Please refer to this study by its identifier: NCT01311232

Queen Mary Hospital
Hing Kong, China
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
National Cancer Center
Singapore, Singapore
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: Won Seog Kim, Professor, Samsung Medical Center Identifier: NCT01311232     History of Changes
Other Study ID Numbers: 2010-11-035
Study First Received: March 6, 2011
Last Updated: January 12, 2013

Keywords provided by Samsung Medical Center:
rituximab, lymphoma, hepatitis B virus

Additional relevant MeSH terms:
Lymphoma, Follicular
Hepatitis B
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liver Diseases
Digestive System Diseases
Lymphoma, Non-Hodgkin
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 23, 2017