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Clinical Trial Summary

In this study, we will evaluate the incidence of hepatitis B virus reactivation within the first 6 months of treatment with rituximab, standard chemotherapy and TAF in patients with diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive.


Clinical Trial Description

This is a prospective, multicenter, interventional, single arm, evaluating the incidence of hepatitis B virus (HBV) reactivation within the first 6 months treatment period in HBsAg positive patients treated for DLBCL/Chronic Lymphoid Leukemia with Rituximab, standard chemotherapy, and TAF. Approximate duration of the recruitment period based on the number of patients available The duration of the recruitment period has been estimated at 12 months. Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy. Then patients will be also observed for further12 months ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03804372
Study type Interventional
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone +39 0670390514
Email p.fazi@gimema.it
Status Recruiting
Phase Phase 2
Start date July 7, 2020
Completion date July 2024

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