Combination of Quizartinib and Omacetaxine Mepesuccinate for AML Carrying FLT3-ITD (NCT03135054) | Clinical Trial Compass
UnknownPhase 2
Combination of Quizartinib and Omacetaxine Mepesuccinate for AML Carrying FLT3-ITD
Hong Kong40 participantsStarted 2017-10-01
Plain-language summary
The study aims to test if combination of quizartinib (AC220) and omacetaxine mepesuccinate (OM, also known as homoharringtonine) results in durable composite complete remission (CRc) in patients with newly diagnosed or relapsed/refractory (R/R) acute myeloid leukemia (AML) carrying FLT3-ITD (Fms-Like Tyrosine Kinase 3 - Internal Tandem Duplication).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provision of written informed consent approved by the Institutional Review Board (IRB).
✓. Age ≥18 years
✓. Documented primary AML or AML secondary to myelodysplastic syndrome (MDS), as defined by World Health Organization criteria
✓. At diagnosis or in morphological relapse after an initial remission or refractory after induction chemotherapy, with or without HSCT
✓. Documentation of FLT3-ITD in BM or blood with allelic burden of ≥ 20% as determined by the study site laboratory
✓. ECOG performance score 0-2
✓. Discontinuation of prior AML treatment ≥ 2 weeks before the start of QUIZOM (except hydroxyurea or other treatment to control leukocytosis).
✓. Serum creatinine ≤1.5×upper limit of normal (ULN), or glomerular filtration rate \>25 mL/min, as calculated with the Cockcroft-Gault formula.
. Uncontrolled or significant cardiovascular disease, including:
✕. In a man whose sexual partner is a woman of childbearing potential, unwillingness or inability of the man or woman to use an acceptable contraceptive method for the entire study treatment period and for at least 3 months after study treatment completion
✕. In a heterosexually active woman of childbearing potential, unwillingness or inability to use an acceptable contraceptive method for the entire study treatment period and for at least 3 months after study treatment completion