OncoMatch

OncoMatch/Clinical Trials/NCT06613217

Study of Oral PCLX-001 in R/R Acute Myeloid Leukemia

Is NCT06613217 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies zelenirstat for relapsed adult aml.

Phase 1RecruitingPacylex PharmaceuticalsNCT06613217Data as of May 2026

Treatment: zelenirstatThis is a dose-finding study of oral zelenirstat (PCLX-001) in patients with R/R AML. There are two parts to the study: Dose Escalation and Dose Expansion.

Check if I qualify

Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Lab requirements

Kidney function

eGFR >60 mL/min (Cockcroft-Gault); creatinine ≤ 1.5x ULN

Liver function

Total bilirubin ≤ 1.5x ULN unless due to hemolysis or congenital disorder; ALT and AST ≤ 2.5x ULN or ≤ 5x ULN for patients with malignant liver involvement

Cardiac function

Adequate cardiac function per institutional normal measured by echocardiography or MUGA (LVEF ≥ 50%)

Patients must have adequate liver function as assessed by the following laboratory tests... Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) unless increase is due to hemolysis or congenital disorder such as Gilbert's syndrome; ALT and AST ≤ 2.5 times ULN or ≤ 5 times ULN for patients with malignant liver involvement. Patients must have adequate kidney function, as assessed by both: the estimated glomerular filtration rate (eGFR) >60 mL/min... creatinine ≤ 1.5 times the ULN. Adequate cardiac function per institutional normal measured by echocardiography or multi-gated acquisition (MUGA) scan (Left ventricular ejection fraction (LVEF) ≥ 50%)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • MD Anderson Cancer Centre · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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 qualify