Back to resultsAn Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients With Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Primary Purpose
Leukemia, Myeloid, Chronic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glivec®/Gleevec®
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Chronic focused on measuring CML in Blast Crisis, Accelerated Phase oe Chronic Phase
Eligibility Criteria
Inclusion Criteria:
- Patients with Imatinib (Glivec/Gleevec) Resistant or Intolerant CML in Blast Crisis, Accelerated Phase or Chronic Phase
Sites / Locations
Outcomes
Primary Outcome Measures
Effectiveness
Secondary Outcome Measures
Full Information
NCT ID
NCT00538109
First Posted
October 1, 2007
Last Updated
December 15, 2015
Sponsor
King Faisal Specialist Hospital & Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00538109
Brief Title
An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients With Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Official Title
An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients With Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Faisal Specialist Hospital & Research Center
4. Oversight
5. Study Description
Brief Summary
An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients with Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Chronic
Keywords
CML in Blast Crisis, Accelerated Phase oe Chronic Phase
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Glivec®/Gleevec®
Intervention Description
Chemotherapy
Primary Outcome Measure Information:
Title
Effectiveness
Time Frame
overall
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Imatinib (Glivec/Gleevec) Resistant or Intolerant CML in Blast Crisis, Accelerated Phase or Chronic Phase
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naeem Chaudhri, MD
Organizational Affiliation
King Faisal Specialist Hospital & Research Centre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients With Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
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