Sirolimus in the Treatment of Refractory/Relapsed wAIHA

Recruiting now · Not applicable

Conditions studied: Warm Autoimmune Hemolytic Anemia

In brief

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.

Key facts

Study ID: NCT05925023
Run by: Peking Union Medical College Hospital
People needed: 22
Starts: 2023-06-24
Expected to finish: 2025-12-01
Last updated by the study team: 2025-08-08

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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
Cirrhosis or portal hypertension.
Pregnant or breastfeeding.

Where it is running

Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.