Status:
COMPLETED
Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborating Sponsors:
Cephalon
ChemGenex Pharmaceuticals
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the safety and efficacy of subcutaneous administration of omacetaxine mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have ...
Detailed Description
Point mutations within the ABL kinase domain of the BCR-ABL gene are emerging as the most frequent mechanism for resistance to imatinib and resultant reactivation of kinase activity. The risk of mutat...
Eligibility Criteria
Inclusion
- Male or female patients, age 18 years or older
- Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase
- The patient will have the T315I BCR-ABL gene mutation
- Patients will have failed prior imatinib therapy
- ECOG performance status 0-2
Exclusion
- NYHA class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension or congestive heart failure
- Myocardial infarction in the previous 12 weeks
- Lymphoid Ph+ blast crisis
Key Trial Info
Start Date :
September 20 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2013
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00375219
Start Date
September 20 2006
End Date
June 28 2013
Last Update
November 15 2021
Active Locations (32)
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1
Teva Investigational Site 003
Los Angeles, California, United States, 90033
2
Teva Investigational Site 007
Jacksonville, Florida, United States, 32224
3
Teva Investigational Site 006
Atlanta, Georgia, United States, 30329
4
Teva Investigational Site 008
Beech Grove, Indiana, United States, 46107