Under construction – not a live service
Sign in

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

Full criteria on ClinicalTrials.gov

Sites (31)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Coordinator of this site? Confirm its status
AlessandriaItalyUnknown status
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
Coordinator of this site? Confirm its status
AnconaItalyUnknown 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 PicenoItalyUnknown status
Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari
Coordinator of this site? Confirm its status
AvianoItalyUnknown status
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Coordinator of this site? Confirm its status
BariItalyUnknown status
Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia
Coordinator of this site? Confirm its status
BariItalyUnknown status
Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia
Coordinator of this site? Confirm its status
BrindisiItalyUnknown status
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
Coordinator of this site? Confirm its status
CataniaItalyUnknown status
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
Coordinator of this site? Confirm its status
ConaItalyUnknown status
Aou Ospedali Riuniti - Foggia - Uoc Ematologia
Coordinator of this site? Confirm its status
FoggiaItalyUnknown status
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
Coordinator of this site? Confirm its status
LecceItalyUnknown status
Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
Coordinator of this site? Confirm its status
MessinaItalyUnknown status
Aou Federico Ii - Napoli - Uoc Ematologia
Coordinator of this site? Confirm its status
NaplesItalyUnknown status
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
Coordinator of this site? Confirm its status
NaplesItalyUnknown status
AOU Maggiore della Carità di Novara, SCDU Ematologia
Coordinator of this site? Confirm its status
NovaraItalyUnknown status
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
Coordinator of this site? Confirm its status
PaganiItalyUnknown status
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
Coordinator of this site? Confirm its status
PalermoItalyUnknown status
Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
Coordinator of this site? Confirm its status
PaviaItalyUnknown status
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
Coordinator of this site? Confirm its status
PescaraItalyUnknown status
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Coordinator of this site? Confirm its status
Reggio EmiliaItalyUnknown status
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
Coordinator of this site? Confirm its status
RiminiItalyUnknown status
Ao San Camillo Forlanini - Roma - Uoc Ematologia E Trapianto Cellule Staminali
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Aou Sant'Andrea - Roma - Uoc Ematologia
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
Coordinator of this site? Confirm its status
San Giovanni RotondoItalyUnknown 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
TorinoItalyUnknown status
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Coordinator of this site? Confirm its status
VeronaItalyUnknown status
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Coordinator of this site? Confirm its status
VicenzaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.