Using sirolimus to treat refractory warm autoimmune hemolytic anemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of sirolimus in patients with refractory or relapsed warm autoimmune hemolytic anemia (wAIHA) and Evans syndrome. The study builds on previous findings that indicated an 80% effective rate of sirolimus in similar patient populations. Participants will be adults aged 18 and older who have not responded to glucocorticoid therapy or have experienced a recurrence of their condition. The trial aims to provide a cost-effective treatment option that could improve patient outcomes and reduce the economic burden associated with this rare disorder.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years old.
2. 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.
3. No response to glucocorticoid therapy or recurrence.
4. Baseline liver (ALT, AST) was less than 2 times the normal value.
5. No active infection; Not pregnant or breastfeeding.
6. Agree to sign the consent form.

Exclusion Criteria:

1. Patients with connective tissue disease or other organs involvement
2. Infection or bleeding that cannot be controlled by standard treatment.
3. Active HIV, HCV or HBV infection or cirrhosis or portal hypertension.
4. Progressed uncontrolled malignant tumors and lymphoma
5. Cirrhosis or portal hypertension.
6. Pregnant or breastfeeding.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CTX112 (zugo-cel) for relapsed/refractory ITP and wAIHA in adults

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• Universal (allogeneic) CAR T-cell therapy targeting CD19 and BCMA for relapsed/refractory autoimmune hemolytic anemia

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• OM336 for autoimmune hemolytic anemia and immune thrombocytopenia

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• National longitudinal cohort of autoimmune hemolytic anemia in China

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• F182112 in relapsed/refractory autoimmune hemolytic anemia

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  Recruiting Phase 1 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07816341

• Brain network changes in adults with anemia measured by fNIRS

  This project will use functional near-infrared spectroscopy (fNIRS) to see if brain network connections are altered in adults aged 18–65 who have anemia.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.