Relapsed/refractory autoimmune hemolytic anemia /Evans syndrome
Conditions
Interventions
Single arm:Orelabrutinib
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients over 18 years old; 2. The confirmed AIHA or Evans syndrome meets the diagnostic criteria of relapsed and refractory; 3. Met the standard of DAT negative AIHA, and had been treated effectively with glucocorticoid and rituximab; 4. Normal function of main organs: serum ALT and AST = 3 months; 7. Provide written informed consent and understand and follow the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Previous diagnosis of lymphoproliferative diseases or other malignant tumors; 2. Pregnant or lactating women; 3. Diagnosis of cold agglutinin disease or cold agglutinin syndrome or paroxysmal cold hemoglobinuria; 4. Secondary AIHA caused by drug or infection; 5. Rituximab was used within 8 weeks before enrollment; 6. Received btki in the past; 7. Previous organ or hematopoietic stem cell transplantation; 8. History of thrombosis or organ infarction; 9. Active stage of connective tissue disease; 10. Hereditary hemolytic disease or acquired hemolytic disease; 11. Uncontrolled systemic fungal, bacterial or viral infection (defined as the symptoms / signs at the time associated with the infection, which did not improve despite the use of antibiotics or other treatment); 12. Known or suspected to be allergic to obutinib; 13. Known active viral infections of human immunodeficiency virus (HIV) or hepatitis B or C virus; 14. Have a clear history of neurological or mental disorders, including epilepsy or dementia; 15. According to the judgment of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study; 16. Using other trial drugs at the same time or participating in clinical trials of other drugs one month before the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete blood count;Liver function;Coombs test;Reticulocyte;Subtype of B lymphocyte; | — |
Countries
China
Contacts
Public ContactFu Rong
Tianjin Medical University General Hospital
Outcome results
None listed