Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250042
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2005-11-03
Brief Title:
A Phase II Study of Gleevec and Arsenic Trioxide in Patients With CML Who Fail Gleevec
Sponsor:
New Mexico Cancer Care Alliance
Organization:
New Mexico Cancer Care Alliance
Study Overview
Official Title:
A Phase II Study of Gleevec and Arsenic Trioxide in Patients With CML Who Fail to Achieve a Complete Response to Initial Gleevec Treatment
Status:
COMPLETED
Status Verified Date:
2009-12
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:
10 OBJECTIVES 11 To test the activity of arsenic trioxide in combination with imatinib in patients with CML with cytogenetic evidence of residual disease
12 To determine the toxicity associated with this therapy
12 To determine the toxicity associated with this therapy
Detailed Description:
Chronic myelogenous leukemia CML results from the clonal expansion of immature myeloid cells with the t 922 Ph translocation that encodes the constitutively active tyrosine kinase oncogene bcrabl Patients with chronic phase CML are currently being treated with either hemopoetic stem cell transplantation HSCT or with the recently approved tyrosine kinase inhibitor imatinib Previous data using interferon in patients with CML has shown that patients who do not achieve a major cytogenetic response defined as 35 Ph have a shortened survival These patients are often considered for HSCT However due to constraints of age suitable donor and patient choice only a minority of patients will undergo this potentially curative procedure
The aim of this study is to create a uniform approach to the treatment of CML in New Mexico with an aim of achieving complete cytogenetic response as the primary goal A graded approach will be taken starting out with the standard treatment imatinib 400 mg per day and then in patients identified as poor responders an imatinib and arsenic combination will be offered to patients It is hoped to find a complete cytogenetic response that exceeds the 20 response with gleevec 800mg per day
The aim of this study is to create a uniform approach to the treatment of CML in New Mexico with an aim of achieving complete cytogenetic response as the primary goal A graded approach will be taken starting out with the standard treatment imatinib 400 mg per day and then in patients identified as poor responders an imatinib and arsenic combination will be offered to patients It is hoped to find a complete cytogenetic response that exceeds the 20 response with gleevec 800mg per day
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