Non-Hodgkin's Lymphoma, Burkitt's Clinical Trial
Official title:
A Multicenter Study to Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma Patients With Isolated Anti-HBc-positivity Who Will be Treated With Rituximab Based Chemotherapy
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention