search
Back to results

The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide (CLL1818)

Primary Purpose

Large-B-cell Diffuse Lymphoma, Chronic Lymphoid Leukemia

Status
Recruiting
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Rituximab
Chemotherapy
Tenofovir alafenamide
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Large-B-cell Diffuse Lymphoma focused on measuring diffuse Large B-Cell Lymphoma, chronic Lymphoid Leukemia HBsAg-positive, Rituximab, chemotherapy, alafenamide, hepatitis B virus reactivation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di EmatologiaRecruiting
  • Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc EmatologiaRecruiting
  • Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica EmatologicaRecruiting
  • Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc EmatologiaRecruiting
  • Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie CellulariRecruiting
  • Aou Consorziale Policlinico - Bari - Uo Ematologia Con TrapiantoRecruiting
  • Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo EmatologiaRecruiting
  • Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo EmatologiaRecruiting
  • Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - CataniaRecruiting
  • Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della CoagulazioneRecruiting
  • Aou Ospedali Riuniti - Foggia - Uoc EmatologiaRecruiting
  • Asl Lecce, Ospedale 'V. Fazzi' - Uo EmatologiaRecruiting
  • Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc EmatologiaRecruiting
  • Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di MidolloRecruiting
  • Aou Federico Ii - Napoli - Uoc EmatologiaRecruiting
  • Aou Maggiore Della Carita' Di Novara - Scdu EmatologiaRecruiting
  • Asl Salerno, Presidio Ospedaliero Tortora Pagani - EmatologiaRecruiting
  • Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con UtmoRecruiting
  • Fondazione Ircss Policlinico San Matteo - Pavia - Uo EmatologiaRecruiting
  • Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia ClinicaRecruiting
  • Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc EmatologiaRecruiting
  • Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo EmatologiaRecruiting
  • Ao San Camillo Forlanini - Roma - Uoc Ematologia E Trapianto Cellule StaminaliRecruiting
  • Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule StaminaliRecruiting
  • Aou Sant'Andrea - Roma - Uoc EmatologiaRecruiting
  • Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc EmatologiaRecruiting
  • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area EmatologicaRecruiting
  • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - EmatologiaRecruiting
  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di TorinoRecruiting
  • Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc EmatologiaRecruiting
  • Aulss 8 Berica - Ospedale Di Vicenza - Uoc EmatologiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of patients presenting hepatitis B virus reactivation
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

Percentage of patients presenting hepatitis B virus reactivation
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
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.
Percentage of patients in which chemotherapy is delayed due to HBV-reactivation.
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 with DLBCL and with Chronic Lymphoid Leukemia who survive
Number of patients experiencing adverse events.

Full Information

First Posted
January 8, 2019
Last Updated
January 3, 2022
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
search

1. Study Identification

Unique Protocol Identification Number
NCT03804372
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
Acronym
CLL1818
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 Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Large-B-cell Diffuse Lymphoma, Chronic Lymphoid Leukemia
Keywords
diffuse Large B-Cell Lymphoma, chronic Lymphoid Leukemia HBsAg-positive, Rituximab, chemotherapy, alafenamide, hepatitis B virus reactivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tenofovir alafenamide
Intervention Description
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 Measure Information:
Title
Percentage of patients presenting hepatitis B virus reactivation
Description
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.
Time Frame
Within 6 months following the start of treatment
Secondary Outcome Measure Information:
Title
Percentage of patients presenting hepatitis B virus reactivation
Description
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
Time Frame
After 12 months following the study entry and start of treatment
Title
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.
Time Frame
After 31 months from study entry
Title
Percentage of patients in which chemotherapy is delayed due to HBV-reactivation.
Description
In terms of percentage of patients with a delay of at least 7 days between chemotherapy cycles stratified by DLBCL and chronic lymphoid leukemia.
Time Frame
After 31 months from study entry
Title
Number of patients with DLBCL and with Chronic Lymphoid Leukemia who survive
Time Frame
After 31 months from study entry
Title
Number of patients experiencing adverse events.
Time Frame
After 31 months from study entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Fazi
Phone
+39 0670390514
Email
p.fazi@gimema.it
First Name & Middle Initial & Last Name or Official Title & Degree
Enrico Crea
Phone
+39 0670390514
Email
e.crea@gimema.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Gentile
Organizational Affiliation
Università Sapienza di Roma
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alessandra Micozzi
Organizational Affiliation
Università Sapienza di Roma
Official's Role
Study Director
Facility Information:
Facility Name
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
City
Roma
State/Province
(rm)
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Gentile
First Name & Middle Initial & Last Name & Degree
Giuseppe Gentile
First Name & Middle Initial & Last Name & Degree
Alessandra Micozzi
Facility Name
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
City
Alessandria
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Pietrasanta
Facility Name
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
City
Ancona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guido Gini
Email
guido.gini@ospedaliriunitimarche.it
Facility Name
Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
City
Ascoli Piceno
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piero Galieni
Facility Name
Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari
City
Aviano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuela Chimienti
Email
echimienti@cro.it
Facility Name
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
City
Bari
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco C Albano
Email
francesco.albano@uniba.it
Facility Name
Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia
City
Bari
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Attilio Guarini
Email
attilioguarini@oncologico.bari.it
Facility Name
Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia
City
Brindisi
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenico Pastore
Email
domenico.pastore0@gmail.com
Facility Name
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
City
Catania
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Di Raimondo
Phone
3284782450
Email
diraimon@unict.it
Facility Name
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
City
Cona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Cuneo
Email
cut@unife.it
Facility Name
Aou Ospedali Riuniti - Foggia - Uoc Ematologia
City
Foggia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenza Fernanda Fesce
Email
cinzia.fesce@libero.it
Facility Name
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
City
Lecce
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Di Renzo
Facility Name
Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
City
Messina
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donato Mannina
Facility Name
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felicetto Ferrara
Email
felicettoferrara@katamail.com
Facility Name
Aou Federico Ii - Napoli - Uoc Ematologia
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrizio Pane
Facility Name
Aou Maggiore Della Carita' Di Novara - Scdu Ematologia
City
Novara
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianluca Gaidano
Facility Name
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
City
Pagani
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catello Califano
Facility Name
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caterina Patti
Facility Name
Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca U Arcaini
Email
luca.arcaini@unipv.it
Facility Name
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
City
Pescara
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elsa Pennese
Facility Name
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
City
Reggio Emilia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiorella Ilariucci
Email
Fiorella.Ilariucci@ausl.re.it
Facility Name
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
City
Rimini
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Merli
Facility Name
Ao San Camillo Forlanini - Roma - Uoc Ematologia E Trapianto Cellule Staminali
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Battistini
Email
rbattistini@scamilloforlanini.rm.it
Facility Name
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Cantonetti
Email
cantonetti@med.uniroma2.it
Facility Name
Aou Sant'Andrea - Roma - Uoc Ematologia
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agostino Tafuri
Phone
3392145880
Email
agostino.tafuri@ospedalesantandrea.it
Facility Name
Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo De Fabritiis
Email
paolo.de.fabritiis@uniroma2.it
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Laurenti
Email
luca.laurenti@Unicatt.it
Facility Name
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
City
San Giovanni Rotondo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Cascavilla
Email
n.cascavilla@operapadrepio.it
Facility Name
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
City
Torino
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Coscia
Email
marta.coscia@unito.it
Facility Name
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
City
Verona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Visco
Facility Name
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
City
Vicenza
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Chiara Tisi
Email
mariachiara.tisi@aulss8.veneto.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33559286
Citation
Picardi M, Giordano C, Della Pepa R, Pugliese N, Leone A, Delle Cave G, Iula R, Pane F, Gentile G. Regarding "Hepatitis B Surface Antigen Positivity Is an Independent Unfavorable Prognostic Factor in Diffuse Large B-Cell Lymphoma in the Rituximab Era". Oncologist. 2021 Jun;26(6):e1083-e1084. doi: 10.1002/onco.13710. Epub 2021 Feb 24.
Results Reference
derived

Learn more about this trial

The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide

We'll reach out to this number within 24 hrs