OncoMatch/Clinical Trials/NCT06778187
Oral-ATO for TP53-mutated Myeloid Malignancies
Is NCT06778187 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06778187 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational agent disqualifies patients from enrollment.
Does this trial require TP53?
Yes, TP53 mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages