Relapsed/refractory autoimmune hemolytic anemia with warm antibody
Conditions
Interventions
Test group:Bendamustine + Rituximab
Sponsors
Suzhou Hongci Blood Disease Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The diagnostic criteria of relapsed/refractory wAIHA were met. The diagnostic criteria of relapsed/refractory wAIHA were as follows: (1) glucocorticoid 1.0-2.0 mg/kg failed to respond after 3 weeks of treatment; (2) glucocorticoid corticosteroid therapy dependence (daily maintenance dose of prednisone >= 15 mg);(3) Two or more treatment measures (glucocorticoid, rituximab, splenectomy) were ineffective or relapsed; (4) Two or more immunosuppressive drugs were used to treat HGB 110g/L. 2. No treatment contraindication; 3. The patient has the ability to understand and is willing to participate in the study, signs the informed consent form (ICF form), and is willing to comply with all study visits and procedures.
Exclusion criteria
Exclusion criteria: 1. At the same time, he suffers from other serious physical or mental diseases that may affect the expression of his condition and the validity of informed consent or lead to the survival of the patient within 2 years; 2. Chronic infections (including bacterial, fungal or viral infections) that are difficult to control should be carried out after effective control;rol, such as dental caries, otitis media, sinusitis, etc., should be carried out after effective control; 3. Severe impairment of immune response (e.g hypogammaglobulinemia, severe decrease in CD4 or CD8 cell count); 4. Severe organ dysfunction; 5. Decompensated hepatic insufficiency and active hepatitis; 6. History of severe autoimmune disease; 7. Other malignant tumors within 5 years before initial diagnosis; 8. History of severe allergy to biological products (including antibiotics); 9. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year recurrence free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| HGB > 20g/L increase from baseline to PR onset times;FACIT fatigue score and improvement of quality of life.;The onset time of HGB rising to normal range and reaching CR/CRi (complete remission with compensated hemolytic state);; | — |
Countries
China
Contacts
Public ContactLimin Liu
Suzhou Hongci Blood Disease Hospital
Outcome results
None listed