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