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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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ClinicalTrials.gov Identifier: NCT00538109
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : December 16, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Naeem A. Chaudhri, King Faisal Specialist Hospital & Research Center

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® Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : October 2007
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013



Intervention Details:
  • Drug: Glivec®/Gleevec®
    Chemotherapy


Primary Outcome Measures :
  1. Effectiveness [ Time Frame: overall ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538109


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

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
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015

Keywords provided by Dr. Naeem A. Chaudhri, 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
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cell Transformation, Neoplastic
Carcinogenesis
Neoplastic Processes
Pathologic Processes
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action