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Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML
Bu çalışma, ileri evre Kronik Miyeloid Lösemi (Chronic Myeloid Leukemia, CML) hastalarında deri altına uygulanan Omasetaksin Mepesüksinat (Homoharringtonin) ilacını inceliyor. Philadelphia kromozomu pozitif, en az iki tirozin kinaz inhibitörü tedavisi başarısız olmuş 18 yaş üstü hastalar dahil edilmiştir. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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