Washington University School of Medicine
This is a single-center, open-label, phase I study with dose escalation and dose expansion testing the combination of ATRN-119 and decitabine in patients with TP53-mutated acute myeloid leukemia (AML) or higher-risk myelodysplastic syndrome (HR-MDS). The dose escalation phase will enroll patients with previously untreated, relapsed, or refractory AML or HR-MDS, regardless of TP53 alteration status, with the primary objective of determining safety and tolerability of ATRN-119 plus decitabine. The dose expansion phase will only enroll patients with previously untreated AML or HR-MDS with a TP53 alteration, with the primary objective of identifying the recommended phase 2 dose (RP2D).
Inclusion Criteria: * Diagnosis of AML or higher-risk MDS (HR-MDS) according to the World Health Organization (WHO) 5th Edition or International Consensus Classification (ICC) 2022 criteria. * HR-MDS is defined as: * IPSS-R (score \> 3.5) or IPSS-M (score \> 0.5) OR ii.≥ 10% bone marrow blasts * Dose Escalation ONLY - One of the following: * Previously untreated AML with ELN 2022 adverse-risk genetic features based on local testing, in patients who are ineligible for intensive induction chemotherapy (cytarabine plus an anthracycline) due to age, comorbidities, or performance status.…
ATRN-119 is provided in 50mg and 100mg capsules or 50mg and 250mg tablets and are administered by mouth.
Decitabine is provided as a 50mg injection in a single-dose vial.
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