OncoMatch/Clinical Trials/NCT06372717
A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS
Is NCT06372717 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including APL-4098 and Azacitidine and APL-4098 for acute myeloid leukemia refractory.
Treatment: APL-4098 · Azacitidine and APL-4098 · Azacitidine and Venetoclax and APL-4098 — This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: allogeneic stem cell transplant
received an allogeneic stem cell transplant within 6 months of screening
Cannot have received: autologous stem cell transplant
received an autologous stem cell transplant within 3 months of screening
Cannot have received: anti-cancer treatments
received any anti-cancer treatments within 2 weeks of Cycle 1 Day 1
Cannot have received: radiation therapy
prior radiation therapy within 4 weeks of screening
Lab requirements
Blood counts
WBC count ≤ 25,000/microliter
Kidney function
calculated or measured creatinine clearance ≥ 45 mL/minute (multiply by 0.85 if female)
Liver function
Aspartate aminotransferase and/or alanine aminotransferase ≤ 3 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN
Cardiac function
Left ventricular ejection fraction ≥ 45%, Fridericia's corrected QT interval ≤ 470msec
WBC count ≤ 25,000/microliter; Left ventricular ejection fraction < 45%, Fridericia's corrected QT interval > 470msec, Aspartate aminotransferase and/or alanine aminotransferase > 3 x upper limit of normal (ULN), total bilirubin > 1.5 x ULN, calculated or measured creatinine clearance < 45 mL/minute (multiply by 0.85 if female)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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