Status:
COMPLETED
Single-dose Anti-CD20 Antibody With Bortezomib for Relapsed Refractory Autoimmune Hemolytic Anemia
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia and Autoimmune Thrombocytopenia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Patients of relapsed and refractory warm autoimmune hemolytic anemia or EVANS syndrome aged 18 to 80 will be included in this study. The treatment regimen is a single dose anti-CD20 antibody (500mg) c...
Detailed Description
Glucocorticoids are the first-line treatment of warm AIHA. The overall response is 70-90%, but 10% to 20% patients are refractory to GCs and more than 50% patients will relapse after GCs tapering or c...
Eligibility Criteria
Inclusion
- Diagnosis of warm autoimmune hemolytic anemia or EVANS syndrome, primary or secondary.
- Patients refractory to glucocorticoids (HGB increase less than 20g/L after three weeks full dose glucocorticoids treatment). Or patients relapse after at least one course of glucocorticoids therapy (HGB \< 110g/L in female and HGB \< 120g/L in male). Or glucocorticoids dependence (prednisone maintenance dose \> 10mg a day). Or glucocorticoids intolerance.
- Normal heart function, liver function (total bilirubin \< 1.5×ULN, ALT, AST \< 3.0 ×ULN), and renal function (serum creatinine \< 1.0 ×ULN).
- No active infection.
- No malignant tumors (except carcinoma in situ).
- Patients understand the content of the study, participate the study and sign the informed consent voluntarily.
Exclusion
- Patients with malignant tumors (excluding carcinoma in situ);
- With uncontrollable infections or other serious diseases;
- Active hepatitis B, serume HBV-DNA \> 104copies/ml;
- Women during pregnancy or lactation;
- Not strict contraception;
- Psychiatric patients and those with severe mental illness.
- Other conditions that researchers consider inappropriate to join the study.
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04083014
Start Date
August 20 2019
End Date
March 20 2024
Last Update
April 26 2024
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730