OncoMatch/Clinical Trials/NCT06778187
Oral-ATO for TP53-mutated Myeloid Malignancies
Is NCT06778187 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Oral arsenic trioxide for acute myeloid leukemia.
Treatment: Oral arsenic trioxide — This is an open-label, phase 2 study of oral arsenic trioxide (Arsenol ®) in combination with ascorbic acid and investigator choice of low-intensity therapy in patients with previously untreated or relapse/refractory TP53-mutated acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS), chronic myelomonocytic leukemia (CMML).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: TP53 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: investigational agent
Use of an investigational agent within 14 days of study treatment (or at least 7 half-lives of that agent, whichever is longer), prior to the first dose of oral arsenic trioxide
Lab requirements
Kidney function
Calculated GFR (Cockcroft-Gault or eGFR CKD-EPI) ≥ 40 mL/min (unless due to hemolysis)
Liver function
ALT or AST < 3 x the local upper limit of normal (unless due to hemolysis)
Cardiac function
No known history of long QT syndrome (LQTS) or QTcF ≥ 480 ms
Evidence at the time of Screening of significant renal or hepatic insufficiency (unless due to hemolysis) as defined by any of the following local laboratory parameters: Calculated GFR < 40 mL/min; ALT or AST ≥ 3 x the local upper limit of normal. Known history of long QT syndrome (LQTS) or corrected QT interval by Fridericia formula (QTcF) ≥ 480 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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