NCT03804372TerminatedPhase 2
The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide
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
Source: ClinicalTrials.gov · Last updated 27 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 8 Jan 2019
- Start date
- 7 Jul 2020
- Primary completion date
- 22 May 2024
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- NCT number
- NCT03804372
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intolerance to any of the components of the therapeutic regimen. Treatment with any investigational medicinal product (unapproved) in the last 30 days.
Other illness
- 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
- 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.
- 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.
Other
- Pregnant or breastfeeding women
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (31)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia Coordinator of this site? Confirm its status | Alessandria | Italy | Unknown status |
| Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia Coordinator of this site? Confirm its status | Ascoli Piceno | Italy | Unknown status |
| Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari Coordinator of this site? Confirm its status | Aviano | Italy | Unknown status |
| Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia Coordinator of this site? Confirm its status | Brindisi | Italy | Unknown status |
| Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione Coordinator of this site? Confirm its status | Cona | Italy | Unknown status |
| Aou Ospedali Riuniti - Foggia - Uoc Ematologia Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
| Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| Aou Federico Ii - Napoli - Uoc Ematologia Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| AOU Maggiore della Carità di Novara, SCDU Ematologia Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia Coordinator of this site? Confirm its status | Pagani | Italy | Unknown status |
| Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica Coordinator of this site? Confirm its status | Pescara | Italy | Unknown status |
| Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia Coordinator of this site? Confirm its status | Rimini | Italy | Unknown status |
| Ao San Camillo Forlanini - Roma - Uoc Ematologia E Trapianto Cellule Staminali Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Aou Sant'Andrea - Roma - Uoc Ematologia Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Unknown status |
| Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia Coordinator of this site? Confirm its status | Vicenza | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.