Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130702
Status:
COMPLETED
Last Update Posted:
2014-05-01
First Post:
2005-08-15
Brief Title:
Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Iressa Gefitinib in Patients With Relapsed or Refractory Acute Myelogenous Leukemia and in Older Patients With Newly Diagnosed Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2014-04
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 determine how effective and to what extent Iressa is in the treatment of acute myelogenous leukemia
Detailed Description:
Patients will receive Iressa daily until either disease progression or intolerable toxicity develops On Day 1 of treatment a physical exam and bloodwork will be performed Once weekly for the first 8 weeks a physical exam and complete blood count with differential will be performed
For the first year a physical exam bloodwork will be performed monthly Bone marrow biopsies will be performed after the first month of therapy and then every 3 months for the first year After the first year a physical exam bloodwork will be performed every 3 months and bone marrow biopsies every 6 months
For the first year a physical exam bloodwork will be performed monthly Bone marrow biopsies will be performed after the first month of therapy and then every 3 months for the first year After the first year a physical exam bloodwork will be performed every 3 months and bone marrow biopsies every 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None