Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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 failed prior imatinib therapy and have the T315I kinase domain gene mutation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Collaborators: Cephalon; ChemGenex Pharmaceuticals
• Treatments: Harringtonines; Homoharringtonine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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