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Prospective Study on the Incidence of Hepatitis B Virus Reactivation in Untreated Patients With Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide
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.
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 All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria, Italy
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
Ancona, Italy
Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
Ascoli Piceno, Italy
Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari
Aviano, Italy
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, Italy
Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia
Bari, Italy
Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia
Brindisi, Italy
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
Catania, Italy
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
Cona, Italy
Aou Ospedali Riuniti - Foggia - Uoc Ematologia
Foggia, Italy
Start Date
July 7, 2020
Primary Completion Date
May 22, 2024
Completion Date
May 22, 2024
Last Updated
February 27, 2025
5
ACTUAL participants
Rituximab
DRUG
Chemotherapy
DRUG
Tenofovir alafenamide
DRUG
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
NCT03852407
NCT02787369
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