Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-05-02
Brief Title:
An Extension Study for Patients Previously Enrolled in Studies With Pelabresib
Sponsor:
Constellation Pharmaceuticals
Organization:
Constellation Pharmaceuticals
Study Overview
Official Title:
An Open-Label Multicenter Extension Study for Patients Previously Enrolled in Studies With Pelabresib
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to provide continued access to treatment with pelabresib for patients who previously received pelabresib in a parent study and to continue collecting safety and efficacy information By collecting efficacy information the study team monitors if pelabresib helps the patient with their disease Additionally survival follow-up data will be collected Survival follow-up collects information on the patients leukemia-free survival and overall survival status life span during and after the treatment is ended If a patient stopped pelabresib treatment on the parent study for any other reason than participation in this study they will not receive further pelabresib treatment but they can enter the study for survival-follow up only
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None