The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide
- Conditions
- Large-B-cell Diffuse LymphomaChronic Lymphoid Leukemia
- Interventions
- Registration Number
- NCT03804372
- 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 All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- Signed written informed consent according to ICH/EU/GCP and national local laws.
- Male/non-pregnant/non-lactating female subjects >18 years old with newly diagnosed DLBCL/Chronic Lymphoid Leukemia who are going to receive treatment with rituximab in combination with chemotherapy.
- HBsAg positivity, serum HBV-DNA negative or positive (<2000/IU), and normal liver function, including alanine aminotransferase(ALT), aspartate aminotransferase(AST) and bilirubin. (inactive carriers).
- No previous treatment with antiviral drugs for HBV infection.
- Patients with satisfactory renal function.
- Hepatic insufficiency for any reason
- History of other liver diseases such as hepatitis C, D, autoimmune hepatitis, primary biliary cirrhosis, Wilsons' disease
- Positive viral markers, such as IgM antibody to hepatitis A virus, hepatitis C virus, IgG antibody to hepatitis D virus, IgM antibody to hepatitis E virus, or antibody to HIV
- Pregnant or breastfeeding women
- Other major systemic diseases, such as active infection, significant cardiac disease, neurological deficit or psychiatric disorder, that the investigators consider being a significant risk
- Patients with moderate or severe renal failure.
- Intolerance to any of the components of the therapeutic regimen. Treatment with any investigational medicinal product (unapproved) in the last 30 days.
- Any other disorder that, in the investigator's opinion, makes the patient ineligible for recruitment or that could interfere in his/her participation or in the conclusion of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study group Tenofovir alafenamide 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. Study group Chemotherapy 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. Study group Rituximab 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.
- Primary Outcome Measures
Name Time Method Percentage of patients presenting hepatitis B virus reactivation Within 6 months following the start of treatment Assessment of the percentage of patients presenting HBV reactivation within 6 months following the start of treatment with Rituximab, chemotherapy and TAF in in DLBCL and Chronic Lymphoid Leukemia patients.
- Secondary Outcome Measures
Name Time Method Number of patients stratified by DLBCL and Chronic Lymphoid Leukemia with hepatitis related to the HBV infection or with liver failure during their participation in the study. After 31 months from study entry Number of patients with DLBCL and with Chronic Lymphoid Leukemia who survive After 31 months from study entry Percentage of patients presenting hepatitis B virus reactivation After 12 months following the study entry and start of treatment Assessment of the percentage of patients presenting HBV reactivation during and after the 12-month treatment of TAF as a single agent in in DLBCL and Chronic Lymphoid Leukemia patients
Percentage of patients in which chemotherapy is delayed due to HBV-reactivation. After 31 months from study entry In terms of percentage of patients with a delay of at least 7 days between chemotherapy cycles stratified by DLBCL and chronic lymphoid leukemia.
Number of patients experiencing adverse events. After 31 months from study entry
Trial Locations
- Locations (31)
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
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
🇮🇹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