Autoimmune Hemolytic Anemia Clinical Trial
Official title:
Tacrolimus Treatment for Refractory Autoimmune Cytopenia
Autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA), pure red cell aplasia (PRCA), Evans syndrome (ES), usually has good responses to steroids therapies as first line, but there is a considerable percentage of patients who relapse, become refractory or dependent on steroids to maintain an acceptable level of hemoglobin or platelets. The effects of the second line therapy are also not satisfactory and sometimes not available. The investigators aim to explore the efficacy and side-effect of tacrolimus for refractory autoimmune cytopenia.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | November 10, 2021 |
Est. primary completion date | August 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Refractory autoimmune cytopenia, including autoimmune hemolytic anemia, pure red cell aplasia, Evans syndrome. - 18-80 years old. - No response or intolerant to first and second line therapies. - ECOG Performance Status of 0-2 - Written informed consent. Exclusion Criteria: - Other diseases which might cause hematological abnormalities. - Response and well tolerate to first or second line therapy. - Patients who are under 18-year-old or over 80-year-old. - Pregnant or lactating. - Patients unwilling to or unable to comply with the protocol. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Li Y, Feng X. Efficacy and safety of tacrolimus in systemic lupus erythematosus patients with refractory thrombocytopenia: a retrospective study. Lupus. 2018 Jan;27(1):60-65. doi: 10.1177/0961203317711011. Epub 2017 May 31. — View Citation
Tabchi S, Hanna C, Kourie HR, Aftimos P, El Osta L, Ghosn M. Successful treatment of Evans syndrome with Tacrolimus. Invest New Drugs. 2015 Feb;33(1):254-6. doi: 10.1007/s10637-014-0155-9. Epub 2014 Sep 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hemoglobin level | Hemoglobin level in g/L | 6 months | |
Primary | Platelet count | Platelet count in /L | 6 months | |
Secondary | Hemoglobin level | Hemoglobin level in g/L | 2 years | |
Secondary | Platelet count | Platelet count in /L | 2 years |
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