Single-dose Anti-CD20 Antibody With Bortezomib for Relapsed Refractory Autoimmune Hemolytic Anemia (NCT04083014) | Clinical Trial Compass
CompletedPhase 2
Single-dose Anti-CD20 Antibody With Bortezomib for Relapsed Refractory Autoimmune Hemolytic Anemia
China33 participantsStarted 2019-08-20
Plain-language 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) combined with bortezomib (1.3mg/m2 twice a week for two weeks). The treatment course would be repeated three months later.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.