Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-03-05 @ 7:34 AM
Study NCT ID:
NCT01311258
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2011-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring Minimal Residual Disease of Patients With Acute Myelogenous Leukemia or High Grade Myelodysplastic Syndrome
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
A Program for Monitoring Minimal Residual Disease Following Treatment of Patients With Acute Myeloid Leukemia or High Grade Myelodysplastic Syndrome
Status:
RECRUITING
Status Verified Date:
2025-09
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:
MRD
Brief Summary:
This study is being performed to develop assays to determine the impact of the therapy patients receive for treatment of AML or MDS and to determine if these tests can identify those patients who are at a greater risk for having their disease relapse.
Detailed Description:
Following therapy, the majority of patients with AML and many patients with MDS will achieve a remission that is defined by the lack of any evidence of the disease when viewing bone marrow samples under a microscope. Despite the absence of disease by this method, many patients in remission will still have what is referred to as Minimal Residual Disease when more sensitive methods are applied. The presence of Minimal Residual Disease following therapy does not guarantee that the patient will experience a relapse. This is likely a result of the failure of these techniques to examine those cells that are responsible for disease relapse. Recent data suggests that in the majority of patients with AML or MDS only a minor population of the malignant cells are capable of maintaining the disease and are likely responsible for relapse following therapy. This minor population of cells can be identified by the proteins they have on their surface. This study tests the ability to identify Minimal Residual Disease following therapy by performing special assays that specifically target this minor population of malignant cells.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: