Single-dose Anti-CD20 Antibody With Bortezomib for Relapsed Refractory Autoimmune Hemolytic Anemia (RRAIHA01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04083014|
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Hemolytic Anemia Autoimmune Hemolytic Anemia and Autoimmune Thrombocytopenia||Drug: combination of a single dose anti-CD20 antibody and bortezomib||Phase 2|
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 cessation.
Anti-CD20 monoclonal antibody is the preferred second-line treatment for relapsed refractory wAIHA. Anti-CD20 antibody 375 mg/m2, once a week, four times, is the standard treatment regimen. Low dose anti-CD20 antibody, 100mg once a week, four times, also showed similar response rate. However, the use of four times of intravenous infusion is trouble. So the investigators intend to explore the efficiency of the singe dose of 500mg anti-CD20 antibody.
Anti-CD20 antibody takes median 6-8 weeks to response and only about 50% patients achieving long-term response. Plasma cells produce antibodies and long-lived plasma cells in bone marrow and spleen continuously work. Bortezomib is a proteasome inhibitor and targets plasma cells. Bortezomib has become a first-line treatment for clonal plasma cell diseases (such as multiple myeloma, systemic amyloidosis, POEMS syndrome, etc.). Bortezomib can also induce reactive plasma cell apoptosis and has a variety of immunomodulatory effects. The investigators try to combine bortezomib with anti-CD20 antibody, which may play a synergistic role and improve the efficacy.
Patients of relapsed and refractory warm autoimmune hemolytic anemia or EVANS syndrome will receive a single dose anti-CD20 antibody (500mg) and bortezomib (1.3mg/m2 twice a week for two weeks) twice for three months interval.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||August 20, 2019|
|Estimated Primary Completion Date :||August 20, 2022|
|Estimated Study Completion Date :||August 20, 2023|
Experimental: study group
The treatment regimen is a single dose anti-CD20 antibody injection (500mg iv drip，day0) combined with bortezomib injection (1.3mg/m2 subcutaneous injection，twice a week for two weeks，day1，4，8，11). The treatment course will be repeated three months later.
Drug: 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.
- response time [ Time Frame: two years ]days hemoglobin increasing more than 20g/L
- overall response [ Time Frame: two years ]total of complete response and partial response
- complete response [ Time Frame: two years ]rate of achieving complete response
- relapse rate [ Time Frame: two years ]relapse rate of responders
- relapse free survival [ Time Frame: two years ]time duration of responders from first treatment to recurrence of decompensated hemolysis
- overall survival [ Time Frame: two years ]time from first treatment to death of any causes
- side effects [ Time Frame: two years ]side effects due to the combination of anti-CD20 antibody and bortezomib
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083014
|Contact: Miao Chen||+86 email@example.com|
|Study Director:||Bing Han||Peking Union Medical College Hospital|