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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT04083014
• Date of registration: 31/08/2019
• Prospective Registration: No
• Primary sponsor: Peking Union Medical College Hospital
• Public title: Single-dose Anti-CD20 Antibody With Bortezomib for Relapsed Refractory Autoimmune Hemolytic Anemia RRAIHA01
• Scientific title: 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
• Date of first enrolment: August 20, 2019
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04083014
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Bing Han
• Affiliation: Peking Union Medical College Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Autoimmune Hemolytic Anemia

Autoimmune Hemolytic Anemia and Autoimmune Thrombocytopenia

Intervention(s)

Drug: combination of a single dose anti-CD20 antibody and bortezomib

Primary Outcome(s)

overall response [Time Frame: two years]

complete response [Time Frame: two years]

relapse rate [Time Frame: two years]

response time [Time Frame: two years]

Secondary Outcome(s)

relapse free survival [Time Frame: two years]

overall survival [Time Frame: two years]

side effects [Time Frame: two years]

Secondary ID(s)

HS-2053

Source(s) of Monetary Support

Please refer to primary and secondary sponsors