Myeloproliferative Neoplasms Clinical Trial
Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML
Summary
A Phase II open-label trial of subcutaneous HHT (omacetaxine mepesuccinate) in the treatment of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.
Full Description
This will be an open label, multicenter study of subcutaneous HHT (omacetaxine mepesuccinate) therapy of patients with chronic myeloid leukemia (CML) in chronic, accelerated, or blast phase who have failed or are intolerant to tyrosine kinase inhibitor therapy. Patients will be treated with induction course cycles consisting of subcutaneous (SC) HHT 1.25 mg/m² twice daily for 14 consecutive days every 28 days. Patients will be evaluated every 7 days with complete blood and platelet counts while undergoing induction therapy; the number of consecutive doses of HHT or intervals between subsequent cycles may be adjusted, as clinically indicated, according to guidelines provided in the treatment plan.
Eligibility 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
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).
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 Criteria:
New York Heart Association classification (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition
Myocardial infarction in the previous 12 weeks.
Other concurrent illness which would preclude study conduct and assessment
uncontrolled and active infection, and positive HIV or positive HTLV I/II status, whether on treatment or not.
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.
Lymphoid Ph+ blast crisis
Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent
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There are 29 Locations for this study
Los Angeles California, 90033, United States
Beech Grove Indiana, 46107, United States
Baltimore Maryland, 21201, United States
Bronx New York, 10466, United States
Buffalo New York, 14263, United States
Philadelphia Pennsylvania, 19111, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Montreal , H3a 1, Canada
Toronto , M5G 2, Canada
Bordeaux , 33076, France
Le Chesnay Cedex , 78157, France
Lille , 59000, France
Lyon Cedex 03 , 69437, France
Nice , 06202, France
Paris , 75475, France
Poitiers Cedex , 86021, France
Strasbourg , 67100, France
Toulouse , 31059, France
Berlin , 10117, Germany
Mannheim , 68169, Germany
Budapest , 1096, Hungary
Hyderabad , 50008, India
Mumbai , 400 0, India
Bologna , 41038, Italy
Gdansk , 80-95, Poland
Warszawa , 02776, Poland
Singapore , 16960, Singapore
London , W12 0, United Kingdom
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