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Assessment of safety and tolerability of drug combination and determine time on treatment, Overall survival (OS) and response rate with patient disease burden, and type of disease
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Inclusion criteria
AML diagnosed by morphologic (with >20% blasts in blood or bone marrow) and histochemical and/or cell surface marker criteria.
Patients with AML must fall into one of the following:
Patients with AML (i.e., > 20% bone marrow blasts) who are deemed unfit* for intensive chemotherapy with refractory or relapsed disease. The patients must have been refractory to at least one cycle of cytarabine containing regimens or at least two cycles of azacitidine or similar hypomethylating agents.
Patients with untreated AML (i.e., > 20% bone marrow blasts) with intermediate risk karyotype (MRC risk group) who are deemed unfit for intensive chemotherapy.
Patients with untreated AML with adverse risk karyotype (MRC risk group) who are deemed unfit for intensive chemotherapy and who are intolerant of azacitidine (or other hypomethylating agents) or who are unable to access azacitidine or other hypomethylating agents.
Patients unfit for conventional intensive chemotherapy are defined as having at least one of the following based on the conceptual criteria of Ferrara (2013):
Age > 17 years.
ECOG performance status of 0-2.
Bone marrow aspirate and/or biopsy for testing for ASS1-deficiency. This must be a fresh sample obtained after any prior chemotherapy and before enrollment in this study. ASS1-deficiency is not required for study entry, but the fresh bone marrow sample must be processed either before or within 1 week of first study dose (see Section 10 for more details).
Exclusion criteria
A subject will not be eligible for study participation if he/she meets any of the exclusion criteria:
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23 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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