Spots Global Cancer Trial Database for The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide
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Trial Identification
Brief Title: The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide
Official Title: 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
Study ID: NCT03804372
Study Description
Brief 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.
Detailed 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 All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia, Roma, (rm), Italy
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
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia, Lecce, , Italy
Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia, Messina, , Italy
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo, Napoli, , Italy
Aou Federico Ii - Napoli - Uoc Ematologia, Napoli, , Italy
Aou Maggiore Della Carita' Di Novara - Scdu Ematologia, Novara, , Italy
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia, Pagani, , Italy
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo, Palermo, , Italy
Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia, Pavia, , Italy
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica, Pescara, , Italy
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia, Reggio Emilia, , Italy
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia, Rimini, , Italy
Ao San Camillo Forlanini - Roma - Uoc Ematologia E Trapianto Cellule Staminali, Roma, , Italy
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali, Roma, , Italy
Aou Sant'Andrea - Roma - Uoc Ematologia, Roma, , Italy
Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia, Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica, Roma, , Italy
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia, San Giovanni Rotondo, , Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino, Torino, , Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia, Verona, , Italy
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia, Vicenza, , Italy
Contact Details
Name: Giuseppe Gentile
Affiliation: Università Sapienza di Roma
Role: STUDY_CHAIR
Name: Alessandra Micozzi
Affiliation: Università Sapienza di Roma
Role: STUDY_DIRECTOR
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