Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058747
Status:
TERMINATED
Last Update Posted:
2012-09-07
First Post:
2003-04-11
Brief Title:
AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec
Sponsor:
Agenus Inc
Organization:
Agenus Inc
Study Overview
Official Title:
Phase II Exploratory Study Of AG-858 Plus Gleevec In Patients With Chronic Myelogenous Leukemia CML In Chronic Phase Who Are Cytogenetically Positive After Treatment With Gleevec
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision of the sponsor
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase II exploratory open-label study of the investigational product AG-858 in patients who are cytogenetically positive after treatment with Gleevec
The trial will consist of three independent Phase II evaluations of patient groups according to their cytogenetic status as defined in the eligibility criteria Eligibility Criteria 4a 4b and 4c
The trial will consist of three independent Phase II evaluations of patient groups according to their cytogenetic status as defined in the eligibility criteria Eligibility Criteria 4a 4b and 4c
Detailed Description:
The goals of this study are to determine the following
To estimate the proportion of patients with a complete cytogenetic response CCR within each patient group
To estimate the proportion of patients with a substantial molecular response SMR within each patient group
To evaluate the frequency and severity of adverse events
To assess the feasibility of AG-858 production
To estimate the proportion of patients with a complete cytogenetic response CCR within each patient group
To estimate the proportion of patients with a substantial molecular response SMR within each patient group
To evaluate the frequency and severity of adverse events
To assess the feasibility of AG-858 production
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