Omacetaxine in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
A multi-center phase II open-label study to evaluate the efficacy and safety of subcutaneous administration of omacetaxine in the treatment of patients with chronic myeloid leukemia (CML) in chronic, accelerated and blast phase who have tested positive for the T315I bcr-abl point mutation.
ChemGenex Pharmaceuticals Inc.
100 participants
Mar 11, 2009
Interventional
Conditions
Summary
This study looks at the effectiveness of chemotherapy with the drug Omacetaxine in people with chronic myeloid leukemia (CML) who have the Philadelphia chromosome (T315I bcr-abl gene) mutation. 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 - tested positive for the T315I bcr-abl point mutation - had no success with tyrosine kinase inhibitor (iminitab - Glivec) treatment. Trial details All participants will be treated with induction course cycles consisting of subcutaneous Omacetaxine administered twice daily for 14 consecutive days every 28 days. Participants who demonstrate a response may receive maintenance therapy for up to 24 months, consisting of subcutaneous Omacetaxine twice daily for 7 days every 28 days. Participants will be evaluated every 7 days with complete blood and platelet counts while undergoing therapy; the number of consecutive doses 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.
Eligibility
Inclusion Criteria7
- 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.
- Acceptable Renal and Liver Function.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Sexually active patients and their partners must use an effective double barrier method of contraception.
Exclusion Criteria7
- New York Heart Association (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.
- Pregnant or lactating.
- Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol.
- Patient is candidate (and has a donor identified) for bone marrow or blood stem cell transplantation.
- Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent.
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Interventions
Omacetaxine mepesuccinate Patient will receive omacetaxine in treatment cycles. Each treatment cycle will have a duration of 28 days and treatment cycles will continue for upto 24 months - without a break between cycles. Dose = 1.25 mg/m2 twice daily for the first 14 days during induction treatment cycles and 1.25 mg/m2 twice a day for the first 7 days during maintenance treatment cycles. Duration: upto 6 months for induction and ~18 months for maintenance (total of 24 months on study). Mode of administration is subcutaneous injection. Patients will be follow up at least every month while on study (upto 24 months).
Locations(28)
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ACTRN12609000373279