Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424639
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
Luspatercept Plus CsA vs CsA for the Treatment of Newly Diagnosed Non-Transfusion-Dependent NSAA
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Randomized Controlled Trial Comparing the Safety and Efficacy of Luspatercept Plus Cyclosporine Versus Cyclosporine Alone for the Treatment of Newly Diagnosed Non-transfusion-dependent Non-severe Aplastic Anemia NSAA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
In a randomized controlled clinical trial the efficacy and safety of rodsipil combined with cyclosporine versus cyclosporine alone in the treatment of newly diagnosed non-transfusion-dependent NSAA were compared
Detailed Description:
Conduct a comparative evaluation of the effectiveness and safety of Luspatercept combined with cyclosporine versus cyclosporine monotherapy in the treatment of newly diagnosed non-transfusion-dependent non-severe aplastic anemia NSAA Patients were randomized in a 11 ratio and assigned to one of two groups Group A Luspatercept combined with cyclosporine received Luspatercept 10 mgkg subcutaneous injection every 3 weeks cyclosporine 3-5mgkgday adjusted based on hematological parameters for at least 6 months to assess efficacy Effective patients continued to receive cyclosporine treatment for at least 15 years with a gradual reduction in dosage Group B cyclosporine received 3-5mgkgday adjusted based on hematological parameters for at least 6 months to assess efficacy with effective patients continuing to receive cyclosporine treatment for at least 15 years with a gradual reduction in dosage Hgb below 60gL was allowed or in emergency conditions blood transfusion was allowed Platelets below 20109L or with obvious bleeding tendency were allowed to receive platelet transfusion If neutrophil count was below 10109L G-CSF was allowed until neutrophil count recovered to above 10109L Symptoms treatment-related adverse events signs blood transfusion volume and laboratory tests including reticulocyte count were recorded at least every 3 months for the first 3 months and every 6 months thereafter until 6 months and bone marrow aspiration biopsy and chromosome examination were performed at least every 6 months to observe efficacy and safety
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