Status:
UNKNOWN
Sirolimus Combined With ATRA for the Treatment of Auto-Immune Anemia
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Autoimmune Anemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Autoimmune anemia (AIA), including autoimmune hemolytic anemia (AIHA), EVENs' syndrome (ES), acquired pure red aplastic anemia (PRCA), is a kind of anemia disease mediated by autoimmunity, which can b...
Eligibility Criteria
Inclusion
- diagnosed as autoimmune anemia (autoimmune hemolytic anemia, pure red aplastic anemia, events syndrome) without organ complications;
- ineffective, relapsed or intolerant patients who have been treated with at least one kind of sufficient current conventional drug (steroids, CsA, CD20 monoclonal antibody, tacrolimus and others) ;
- normal cardiac function, liver function (total bilirubin ≤ 1.5 × ULN, ALT/AST ≤ 3.0 × ULN) and renal function (serum creatinine ≤ 1 × ULN);
- no secondary disease;
- unable to accept hematopoietic stem cell transplantation;
- ECoG score ≤ 2;
- able to sign the informed consent form.
Exclusion
- failure to make a definite diagnosis;
- AIA secondary to known diseases such as systemic lupus erythematosus, rheumatoid arthritis, tumor or other inflammatory diseases;
- severe hepatorenal insufficiency (creatinine, transaminase more than 3 times of the upper limit of normal value);
- uncontrollable systemic infection or other serious diseases;
- pregnant or lactating women;
- patients with mental disease who are unable to sign the informed consent;
- taking other AIA drugs or stopping the drugs for less than 3 months;
- allergic to the study drug;
- participation in other clinical studies;
- patients in any other circumstances considered unsuitable by the investigator.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04324411
Start Date
April 1 2020
End Date
December 1 2022
Last Update
March 27 2020
Active Locations (1)
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1
Peking union medical college hospital
Beijing, China