Sirolimus in the Treatment of Refractory/Relapsed wAIHA
ConditionWarm Autoimmune Hemolytic Anemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorPeking Union Medical College Hospital
About this trial
Autoimmune hemolytic anemia (AIHA) is a rare and heterogeneous disorder characterized by the destruction of red blood cells through warm or cold antibodies. Glucocorticoid (combined with rituximab) is the first-line treatment. However, the recurrence rate is very high and some patients may not respond to steroids. Second-line therapies include cyclosporine A (CsA), cyclophosphamide, rituximab, azathioprine, and even splenectomy. Our previous study of sirolimus in refractory/relapsed AIHA and ES found an effective rate of 80%. Therefore, the investigators plan to explore the efficacy and safety of sirolimus in the treatment of refractory/relapsed wAIHA.
Eligibility criteria
Qualifiers
Age ≥18 years old.
Diagnosed as primary warm autoimmune hemolytic anemia or Evans syndrome (primary or secondary). There is no treatment indication of other systemic involvement in the original disease if secondary.
No response to glucocorticoid therapy or recurrence.
Baseline liver (ALT, AST) was less than 2 times the normal value.
Disqualifiers
Patients with connective tissue disease or other organs involvement
Infection or bleeding that cannot be controlled by standard treatment.
Active HIV, HCV or HBV infection or cirrhosis or portal hypertension.
Progressed uncontrolled malignant tumors and lymphoma
Trial design
Treatments tested in this trial
- Sirolimus
Treatment groups
22 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov