Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925023
Status:
RECRUITING
Last Update Posted:
2023-08-21
First Post:
2023-06-21
Brief Title:
Sirolimus in the Treatment of RefractoryRelapsed wAIHA
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Sirolimus in the Treatment of RefractoryRelapsed Warm Autoimmune Hemolytic Anemia AIHA a Phase 2 Prospective Trial
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Autoimmune hemolytic anemia AIHA is a rare and heterogeneous disorder characterized by the destruction of red blood cells through warm or cold antibodies Glucocorticoid combined with rituximab is the first-line treatment However the recurrence rate is very high and some patients may not respond to steroids Second-line therapies include cyclosporine A CsA cyclophosphamide rituximab azathioprine and even splenectomy Our previous study of sirolimus in refractoryrelapsed AIHA and ES found an effective rate of 80 Therefore the investigators plan to explore the efficacy and safety of sirolimus in the treatment of refractoryrelapsed wAIHA
Detailed Description:
Based on the optimal autoantibody-RBC reactivity temperatures AIHA is classified into warm type cold type and mixed type AIHA can be further classified into primary or secondary in nature Glucocorticoid combined with rituximab is the first-line treatment However the recurrence rate is very high and some patients may not respond to steroids Second-line therapies include cyclosporine A CsA cyclophosphamide rituximab azathioprine and even splenectomy The refractoryrelapsed wAIHA patients have increased cardiovascular events increased opportunities for infections decreased quality of life and even death A prospective multi-institutional trial in autoimmune cytopenia found that 8 of 10 patients with AIHA and Evans syndrome respond to sirolimus Our previous study of sirolimus in refractoryrelapsed AIHA and ES also found an effective rate of approximately 80 Since sirolimus is cheap and accessible our findings may reduce the economic burden of patients and be a guide on the selection of second-line treatment drugs in refractoryrelapsed wAIHA and Evans syndrome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None