Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT06113302
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2023-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if luspatercept is more effective in helping to reduce the number of blood transfusions needed by patients with LR-MDS.
Detailed Description:
Objectives:
Primary Objectives:
* To assess the clinical activity and safety of luspatercept in patients with transfusion independent lower risk MDS
* To assess the clinical activity and safety of luspatercept in patients with transfusion dependent lower risk MDS
* To study the effects on hematopoeisis of luspatercept in patients treated on this study
Secondary Objectives:
* To assess the duration of response of patients with treated with luspatercept in this study
* To assess the overall survival and time to transformation of patients with treated with luspatercept in this study
* To assess transfusion free survival period in patients that were transfusion independent treated with luspatercept in this study
* To measure trends in neutrophil and platelet counts in patients treated in this study
Primary Objectives:
* To assess the clinical activity and safety of luspatercept in patients with transfusion independent lower risk MDS
* To assess the clinical activity and safety of luspatercept in patients with transfusion dependent lower risk MDS
* To study the effects on hematopoeisis of luspatercept in patients treated on this study
Secondary Objectives:
* To assess the duration of response of patients with treated with luspatercept in this study
* To assess the overall survival and time to transformation of patients with treated with luspatercept in this study
* To assess transfusion free survival period in patients that were transfusion independent treated with luspatercept in this study
* To measure trends in neutrophil and platelet counts in patients treated in this study
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-09312 | OTHER | NCI-CTRP Clinical Trials Registry | View |