Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutatio
- Conditions
- Health Condition 1: null- Chronic Myeloid Leukemia
- Registration Number
- CTRI/2013/06/003748
- Lead Sponsor
- ChemGenex Pharmaceuticals now Teva Pharmaceutical Industries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Note: Since there is no upper age limit defined for this trial, for the CTRI registration purpose we have included the upper age limit to be considered as 99 years.
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
Bilirubin <= 2.0 times upper limit of normal (ULN), ALT <= 3 times ULN, Creatinine <= 1.5 times
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method