Clinical trial
An Open, One-arm, Prospective Study of a Single Dose Anti-CD20 Monoclonal Antibody Combined With Bortezomib for Treatment of Relapsed Refractory Autoimmune Hemolytic Anemia
Name
HS-2053
Description
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) combined with bortezomib (1.3mg/m2 twice a week for two weeks). The treatment course would be repeated three months later.
Trial arms
Trial start
2019-08-20
Estimated PCD
2024-03-01
Trial end
2024-03-20
Status
Completed
Phase
Early phase I
Treatment
combination of a single dose anti-CD20 antibody and bortezomib
Relapsed and refractory warm AIHA patients receive treatment of combination of a single dose anti-CD20 antibody and bortezomib twice during three months interval.
Arms:
study group
Other names:
Rituximab Injection, Bortezomib for Injection
Size
33
Primary endpoint
response time
two years
overall response
two years
complete response
two years
relapse rate
two years
Eligibility criteria
Inclusion Criteria:
1. Diagnosis of warm autoimmune hemolytic anemia or EVANS syndrome, primary or secondary.
2. 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.
3. Normal heart function, liver function (total bilirubin \< 1.5×ULN, ALT, AST \< 3.0 ×ULN), and renal function (serum creatinine \< 1.0 ×ULN).
4. No active infection.
5. No malignant tumors (except carcinoma in situ).
6. Patients understand the content of the study, participate the study and sign the informed consent voluntarily.
Exclusion Criteria:
1. Patients with malignant tumors (excluding carcinoma in situ);
2. With uncontrollable infections or other serious diseases;
3. Active hepatitis B, serume HBV-DNA \> 104copies/ml;
4. Women during pregnancy or lactation;
5. Not strict contraception;
6. Psychiatric patients and those with severe mental illness.
7. Other conditions that researchers consider inappropriate to join the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 33, 'type': 'ACTUAL'}}
Updated at
2024-04-26
1 organization
1 product
2 indications
Organization
Peking Union Medical College HospitalIndication
Autoimmune Hemolytic Anemia