Hematological Tumors where the doctor considers there to be a high risk of HBV reactivation
Conditions
Interventions
None listed
Sponsors
Kumamoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Having a history of past HBV infection (HBc antibody-positive and/or HBs antibody-positive among HBs antigen-negative cases). However, cases with HBs antibody positivity alone and a history of HBV vaccination are excluded. 2) The attending physician judges the patient to be at high risk of HBV reactivation, and the patient is either scheduled for treatment of a hematologic disease or is within 4 weeks of starting treatment. The type of hematologic disease or treatment is not specified. As a reference, treatments expected to carry a high risk of HBV reactivation include: - Anti-CD20 monoclonal antibody therapy and steroid combination chemotherapy - Initial or salvage chemotherapy for lymphoid malignancies (such as malignant lymphoma, multiple myeloma, acute and chronic lymphocytic leukemia) - Autologous or allogeneic hematopoietic stem cell transplantation - Cellular immunotherapy (such as CAR-T cell therapy or bispecific antibodies) 3) Plans are in place for HBV reactivation prevention through HBV-DNA monitoring as recommended by the Japan Society of Hepatology guidelines. 4) A history of HBV reactivation (defined as HBV-DNA of 1.3 Log IU/mL or higher) is irrelevant. Patients with a history of nucleotide analogue therapy for HBV reactivation are also eligible for enrollment. 5) Re-enrollment is permitted for cases where the 1.5-year follow-up period has been completed.
Exclusion criteria
Exclusion criteria: 1) The pre-enrollment HBV-DNA level is 1.3 Log IU/mL or higher (if measured at the enrolling facility within 4 weeks prior to enrollment). 2) The diagnosis of previous HBV reactivation occurred within 12 months prior to enrollment. 3) There is a history of nucleotide analogue administration, and it has been within 6 months since its discontinuation. 4) Nucleotide analogue therapy is being administered at the time of enrollment. 5) It is clearly impossible to plan for a 1.5-year follow-up at the enrolling facility after enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of iTACT-HBcrAg monitoring | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) HBV reactivation rate 2) Incidence rate of HBV reactivation-related liver damage/hepatitis 3) Specificity of iTACT-HBcrAg 4) Rate of HBs antibody positivity 5) Success rate of iTACT-HBsAg monitoring (ancillary study) 6) Specificity of iTACT-HBsAg (ancillary study) | — |
Countries
Japan
Contacts
Public ContactHiro Tatetsu
Kumamoto University Hospital Department of Hematology, Rheumatology and Infectious Diseases
Outcome results
None listed