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Hepatitis B Virus Reactivation in Asian Patients Treated With Rituximab-containing Treatment

15 Years
90 Years
Open (Enrolling)
Patients With Diffuse Large B-cell Lymphoma or Follicular Lymphoma, Patients Treated With Rituximab-CHOP or Rituximab-CVP

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Trial Information

Hepatitis B Virus Reactivation in Asian Patients Treated With Rituximab-containing Treatment

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

Inclusion Criteria

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

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

Hepatitis B virus reactivation

Outcome Time Frame:

one year

Safety Issue:



Korea: Ministry for Health, Welfare and Family Affairs

Study ID:




Start Date:

November 2010

Completion Date:

December 2013

Related Keywords:

  • Patients With Diffuse Large B-cell Lymphoma or Follicular Lymphoma
  • Patients Treated With Rituximab-CHOP or Rituximab-CVP
  • rituximab, lymphoma, hepatitis B virus
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse