Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05583552
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2022-10-13
Brief Title:
Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy
Sponsor:
GCP-Service International West GmbH
Organization:
GCP-Service International West GmbH
Study Overview
Official Title:
A Phase II Study Evaluating the Efficacy and Safety of Imetelstat in Patients With HR Myelodysplastic Syndromes or AML Failing HMA-based Therapy
Status:
RECRUITING
Status Verified Date:
2024-06
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:
IMpress
Brief Summary:
The purpose of this study is to evaluate the efficacy in terms of hematologic improvement and safety of imetelstat in participants with high-risk HR myelodysplastic syndrome MDS or acute myeloid leukemia AML that is relapsedrefractory to hypomethylating agents HMAs treatment Responding patients are eligible to continue treatment until loss of responsedisease progression
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?:
True
Is an FDA AA801 Violation?:
None