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OncoMatch/Clinical Trials/NCT06613217

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

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

Phase 1RecruitingPacylex PharmaceuticalsNCT06613217Data as of Jun 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.

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Extracted eligibility criteria

Treatments studied

Other

zelenirstat

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.

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Frequently asked questions

Is NCT06613217 currently recruiting?

Yes, this trial is currently recruiting patients.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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