A Phase 2 interventional study of Rituximab and Chemotherapy in Large-B-cell Diffuse Lymphoma and Chronic Lymphoid Leukemia, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Terminated at 31 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Phase 2, Interventional, and Treatment
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.
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 All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.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
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 5 is below the median of 120 across 1,187 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 132 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.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 · Drug: 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 All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.
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.
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.
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.
Time frame: Within 6 months following the start of treatment
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
Time frame: After 12 months following the study entry and start of treatment
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
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.
Time frame: After 31 months from study entry
Number of patients with DLBCL and with Chronic Lymphoid Leukemia who survive
Time frame: After 31 months from study entry
Number of patients experiencing adverse events.
Time frame: After 31 months from study entry
Plan to share: No
This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gruppo Italiano Malattie EMatologiche dell'Adulto