hematologic malignacy
Conditions
Interventions
Three cohorts:For HBV-DNA positive donor: entecavir 0.5 mg/d
Hepatitis B surface antigen positive patients by entecavir 0.5 mg/d HBsAg negative patient passivity HBV immune globulin treatment 400 IU after transplantation 0, 1, 2 months, 1 year after transplanta
Sponsors
the First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged older than 18 years old; 2. Patients diagnosed with hematologic malignacy according to WHO criterias; 3. Patients acquired complete remission who prepare to accept hematopoietic stem cell transplantation; 4. The stem cell source was peripheral stem cell source; 5. The donor of HSCT was tested with HBsAg-positive in two consecutive times (with or without HBV-DNA positive), with no no viable alternative donors; 6. ECOG physical status score 0~2 score; 7. Estimated lifetime longer than 3 months; 8. No major organ dysfunction; 9. Volunteer for this clinical trial. The informed consent is signed by the subjects.
Exclusion criteria
Exclusion criteria: 1. Patients with severe heart dysfunction. Cardiac ejection fraction was lower than 60%. Patients with severe?arrhythmia; 2. Patients have suitable alternative donors; 3. Previous history of drug resistance with Entecavir. Previous history of allergic shock with Entecavir; 4. Previous history of allergic?shock with hepatitis B immune globulin or hepatitis B virus vaccination; 5. Patients with severe lung dysfunction; 6. Patients with severe liver dysfunction; 7. Patients with severe renal dysfunction; 8. An uncontrolled or severe infection; 9. Previous history of severe anaphylactic reaction or adverse reaction; 10. Patients relapsed in bone marrow (more than 5% blasts). Patients who were found extramedullary relapse; 11. Other reasons evaluated by researchers that patients were not compliant with inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cumulative incidence of HBV-related hepatitis; | — |
Secondary
| Measure | Time frame |
|---|---|
| non-relapse mortality;Liver-related mortality; | — |
Countries
China
Contacts
Public ContactYi Luo
the First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed