Single-dose Anti-CD20 Antibody With Bortezomib for Relapsed Refractory Autoimmune Hemolytic Anemia

• Status: Recruiting
• Trial end date: 2023-08-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Antibodies; Antibodies, Monoclonal; Bortezomib; Immunoglobulins; Rituximab

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.