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

• Sponsor: King Faisal Specialist Hospital & Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00538109
• Collaborator: (none)
• Enrollment: 8
• Duration (Months): 72

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Chronic	Drug: Glivec®/Gleevec®	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2007
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Outcome Measures

Primary Outcome Measures

1. Effectiveness [overall]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with Imatinib (Glivec/Gleevec) Resistant or Intolerant CML in Blast Crisis, Accelerated Phase or Chronic Phase

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• King Faisal Specialist Hospital & Research Center

Investigators

• Principal Investigator: Naeem Chaudhri, MD, King Faisal Specialist Hospital & Research Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Naeem A. Chaudhri, Principal Investigator, King Faisal Specialist Hospital & Research Center
• ClinicalTrials.gov Identifier: NCT00538109
• Other Study ID Numbers: RAC #2071-008
• First Posted: Oct 2, 2007
• Last Update Posted: Dec 16, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Dr. Naeem A. Chaudhri, Principal Investigator, King Faisal Specialist Hospital & Research Center: CML in Blast Crisis; Accelerated Phase oe Chronic Phase
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Blast Crisis; Imatinib Mesylate

Study Results

No Results Posted as of Dec 16, 2015