None listed
Conditions
Brief summary
This study looks at the effectiveness of chemotherapy with the drug Omacetaxine in people with chronic myeloid leukemia (CML). Who is it for? You can join this study if you have chronic myeloid leukemia (CML) (cancer of blood cells) which is in chronic, accelerated, or blast phase and you have have had no success with or have been intolerant to therapy with tyrosine kinase inhibitors (iminitab - Glivec). Trial details All participants will be treated with induction course cycles consisting of subcutaneous (SC) Omacetaxine administered twice daily for 14 consecutive days every 28 days. During this induction therapy, participants will be evaluated every 7 days with complete blood and platelet counts; the number of consecutive dose s of Omacetaxine or intervals between subsequent cycles may be adjusted as necessary, according to guidelines provided in the treatment plan. Omacetaxine causes programmed cell death in myeloid cancer cells. Patients will be monitored from the beginning of treatment until any return of the disease or until they die. The study aims to measure the effectiveness of treatment, and investigates the tolerance to and toxicity of Omacetaxine.
Interventions
Omacetaxine mepesuccinate
Patient will be treated with omacetaxine in treatment cycles of 28 days duration. There will be no breaks between treatment cycles and the cycles will continue for upto 24 months.
Dose = 1.25 mg/m2 twice daily for 14 days during induction and 1.25 mg/m2 twice daily for 7 days during maintenance)
Duration: Induction upto 6 months; maintenance upto 18 months (total of 24 months)
Mode of administration is Subcutaneous injection
Sponsors
ChemGenex Pharmaceuticals Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients, age 18 years or older 2. Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase 3. Patients will have either failed, demonstrated intolerance, or a combination of prior failure and intolerance, to prior treatments with at least two tyrosine kinase inhibitors (TKI's). Failure of TKI treatment may either be primary (never achieved a response) or secondary resistance (loss of response). 4. Acceptable Renal and Liver Function 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 6. Sexually active patients and their partners must use an effective double barrier method of contraception.
Exclusion criteria
1. New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition 2. Myocardial infarction in the previous 12 weeks. 3. Other concurrent illness which would preclude study conduct and assessment uncontrolled and active infection, and positive human immunodeficiency virus (HIV) or positive Human T-lymphotropic virus (HTLV) I/II status, whether on treatment or not. 4. Pregnant or lactating. 5. Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol. 6. Lymphoid Ph+ blast crisis 7. Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent.
Outcome results
None listed