Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351306
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-02
Brief Title:
DEC-C and Thioguanine for RR AML
Sponsor:
Joseph Jurcic
Organization:
Columbia University
Study Overview
Official Title:
A Phase II Open-Label Single Center Trial of Oral Decitabine-Cedazuridine DEC-C Inqovi in Combination With Thioguanine Tabloid in Patients With Relapsed or Refractory RR Acute Myeloid Leukemia AML
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The purpose of this study is to find out if oral decitabine-cedazuridine Inqovi is effective safe and able to be tolerated without severe side effects when given with thioguanine Tabloid in patients with acute myeloid leukemia AML whose disease has returned or did not respond to treatment relapsed or refractory
This is a phase II trial with a safety lead-in The goal of the lead-in portion of the study is to make sure participants are getting the highest dose of medications that are safe If too many serious side effects are seen with the dose previously studied some additional patients may be treated with a lower dose to make sure that this dose is safe
This is a phase II trial with a safety lead-in The goal of the lead-in portion of the study is to make sure participants are getting the highest dose of medications that are safe If too many serious side effects are seen with the dose previously studied some additional patients may be treated with a lower dose to make sure that this dose is safe
Detailed Description:
Acute myeloid leukemia AML is a cancer of the blood and bone marrow with a 5-year survival rate of 475 for patients less than age 65 years and only an 82 survival for those 65 and older based on data from the Surveillance Epidemiology and End Results SEER program of the National Cancer Institute Despite some advances in treatment most patients will relapse and treatment remains limited especially for patients that progress on the standard of care The expected response rate to salvage chemotherapy is only 10-20 with a median survival typically of less than 6 months The need for new effective and well-tolerated treatments is clear
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