Sirolimus in the Treatment of Refractory/Relapsed wAIHA (NCT05925023) | Clinical Trial Compass
RecruitingNot Applicable
Sirolimus in the Treatment of Refractory/Relapsed wAIHA
China22 participantsStarted 2023-06-24
Plain-language summary
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.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. 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.
✓. No active infection; Not pregnant or breastfeeding.
✓. Agree to sign the consent form.
Exclusion criteria
✕. 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
What they're measuring
1
Overall response rate (ORR) and complete response rate (CRR)