Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Naeem A. Chaudhri, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT00538109
First received: October 1, 2007
Last updated: April 16, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Leukemia, Myeloid, Chronic
 Drug: Glivec®/Gleevec®

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • Effectiveness [ Time Frame: overall ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: October 2007
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Glivec®/Gleevec®
    Chemotherapy
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Imatinib (Glivec/Gleevec) Resistant or Intolerant CML in Blast Crisis, Accelerated Phase or Chronic Phase
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538109

Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Naeem Chaudhri, MD King Faisal Specialist Hospital & Research Centre
  More Information

No publications provided

Responsible Party: Dr. Naeem A. Chaudhri, Principal Investigator, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT00538109     History of Changes
Other Study ID Numbers: RAC #2071-008
Study First Received: October 1, 2007
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by King Faisal Specialist Hospital & Research Center:
CML in Blast Crisis
Accelerated Phase oe Chronic Phase

Additional relevant MeSH terms:
Blast Crisis
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Cell Transformation, Neoplastic
Neoplastic Processes
Myeloproliferative Disorders
Bone Marrow Diseases
 Hematologic Diseases
Pathologic Processes
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013