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

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ClinicalTrials.gov Identifier: NCT03804372
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Condition or disease Intervention/treatment Phase
Large-B-cell Diffuse Lymphoma Chronic Lymphoid Leukemia Drug: Rituximab Drug: Chemotherapy Drug: Tenofovir alafenamide Phase 2

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 All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 7, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023


Arm Intervention/treatment
Experimental: Study group
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.
Drug: 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.

Drug: 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.

Drug: 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.




Primary Outcome Measures :
  1. Percentage of patients presenting hepatitis B virus reactivation [ Time Frame: 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 :
  1. Percentage of patients presenting hepatitis B virus reactivation [ Time Frame: 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

  2. 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 ]
  3. Percentage of patients in which chemotherapy is delayed due to HBV-reactivation. [ Time Frame: 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.

  4. Number of patients with DLBCL and with Chronic Lymphoid Leukemia who survive [ Time Frame: After 31 months from study entry ]
  5. Number of patients experiencing adverse events. [ Time Frame: After 31 months from study entry ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03804372


Contacts
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Contact: Paola Fazi +39 0670390514 p.fazi@gimema.it
Contact: Enrico Crea +39 0670390514 e.crea@gimema.it

Locations
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Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia Not yet recruiting
Roma, (rm), Italy
Contact: Giuseppe Gentile         
Principal Investigator: Giuseppe Gentile         
Sub-Investigator: Alessandra Micozzi         
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia Recruiting
Alessandria, Italy
Contact: Daniela Pietrasanta         
Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia Recruiting
Ascoli Piceno, Italy
Contact: Piero Galieni         
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia Recruiting
Lecce, Italy
Contact: Nicola Di Renzo         
Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia Recruiting
Messina, Italy
Contact: Donato Mannina         
Aou Federico Ii - Napoli - Uoc Ematologia Recruiting
Napoli, Italy
Contact: Fabrizio Pane         
Aou Maggiore Della Carita' Di Novara - Scdu Ematologia Recruiting
Novara, Italy
Contact: Gianluca Gaidano         
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo Recruiting
Palermo, Italy
Contact: Caterina Patti         
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica Recruiting
Pescara, Italy
Contact: Elsa Pennese         
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia Recruiting
Rimini, Italy
Contact: Anna Merli         
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia Recruiting
Verona, Italy
Contact: Carlo Visco         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Study Chair: Giuseppe Gentile Università Sapienza di Roma
Study Director: Alessandra Micozzi Università Sapienza di Roma
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT03804372    
Other Study ID Numbers: CLL1818
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
diffuse Large B-Cell Lymphoma
chronic Lymphoid Leukemia HBsAg-positive
Rituximab
chemotherapy
alafenamide
hepatitis B virus reactivation
Additional relevant MeSH terms:
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Hepatitis B
Lymphoma
Leukemia
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Hepatitis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Leukemia, B-Cell
Tenofovir
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antiviral Agents