The objective of this study is to analyze factors affecting Hepatitis B Virus (HBV) reactivation in anti-HBc positive patients with Non-Hodgkin's lymphoma treated with rituximab and compare HBV reactivation rates by duration of prophylactic treatment with tenofovir to contribute to the establishment of an effective prevention strategy.
This study will be conducted in a randomized, open-label, multi-center design. On Day 1 of chemotherapy, approximately 90 subjects screened and determined eligible will be randomized to either Group A or Group B in a 1:1 manner for study participation. * Group A: Upon the EOC, subjects will receive tenofovir 300mg for approximately 6 months (24 weeks) and undergo treatment and follow-up every 12 weeks for up to 72 weeks post chemotherapy. * Group A: Upon the EOC, subjects will receive tenofovir 300mg for approximately 12 months (48 weeks) and undergo treatment and follow-up every 12 weeks for up to 72 weeks post chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
90
Anti-HBc positive patients with Non-Hodgkin's lymphoma planned to receive rituximab based chemotherapy will be randomized to either Group A or Group B in a 1:1 ratio and will be monitored every 12 weeks from the start of treatment for up to 72 weeks after the end of chemotherapy (EOC).
Seoul National University
Seoul, South Korea
RECRUITINGHBV reactivation: defined as an increase in HBV DNA at least 10 folds from nadir or reappearance of HBsA or HBeAg in blood during treatment.
Time frame: after 48 week from the End of treatment
Hepatitis flare: defined as elevation of HBV viral load more than 2,000IU/ml from the baseline or by the reappearance of HBsAg and elevation of ALT at least 100IU/ml from the baseline.
Time frame: after 48 week from the End of treatment
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