Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037882
Status:
TERMINATED
Last Update Posted:
2018-11-01
First Post:
2002-05-24
Brief Title:
PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of SCH 54031 Peg Interferon Alpha-2BPEG-Intron in Subjects With Interferon-Refractory Chronic Myelogenous Leukemia
Status:
TERMINATED
Status Verified Date:
2018-10
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 if PEG-Intron is better tolerated and more efficacious than standard interferons Roferon Intron in patients with Philadelphia-positive Chronic Myelogenous Leukemia These patients should have previously received standard interferon therapy and have been intolerant resistant or have relapsed disease
Detailed Description:
It has been shown that patients who experience complete hematologic or at least a partial cytogenetic response to interferon will have improved survival times In addition evidence exists that even patients who do not demonstrate a cytogenetic response to interferon treatment can still benefit from treatment in terms of survival compared to patients not treated with interferon This indicates that if a patient is better able to tolerate interferon he or she may have improved survival even without cytogenetic response Preliminary studies suggest that PEG-Intron is more convenient for patients administered once weekly rather than daily is better tolerated than interferon and can produce hematologic remission in interferon-a resistant patients Phase II studies are needed to ascertain the overall hematologic and cytogenetic response rates to PEG-Intron in such patients
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