OncoMatch

OncoMatch/Clinical Trials/NCT05829226

A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)

Is NCT05829226 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including LYT-200 and Venetoclax for aml, adult recurrent.

Phase 1RecruitingPureTechNCT05829226Data as of May 2026

Treatment: LYT-200 · Venetoclax · Azacitidine · Decitabine — A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), or with Relapsed/refractory, High-risk Myelodysplastic Syndrome (MDS)

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Performance status

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

Prior therapy

Min 1 prior line

Lab requirements

Blood counts

White blood cell (WBC) count at the time of the first dose of < 25,000/uL

Kidney function

Creatinine clearance of ≥ 60 mL/min

Liver function

Aspartate aminotransferase or alanine aminotransferase ≤ 3 × ULN (≤ 5.0× ULN if considered to be due to leukemic involvement); Total bilirubin ≤ 2 × ULN (≤ 3 × ULN if considered to be due to leukemic involvement or Gilbert's syndrome)

Cardiac function

LVEF ≥ 45% required if history of NYHA class 3 or 4 congestive heart failure in past

White blood cell (WBC) count at the time of the first dose of < 25,000/uL. Aspartate aminotransferase or alanine aminotransferase ≤ 3 × ULN (≤ 5.0× ULN if considered to be due to leukemic involvement). Total bilirubin ≤ 2 × ULN (≤ 3 × ULN if considered to be due to leukemic involvement or Gilbert's syndrome). Creatinine clearance of ≥ 60 mL/min.

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

US trial sites

  • Cedars-Sinai Medical Center · Los Angeles, California
  • University of California Irvine Medical Center · Orange, California
  • Baptist Health South Florida-Miami Cancer Institute · Miami, Florida
  • Norton Healthcare-Norton Cancer Institute · Louisville, Kentucky
  • Mass. General Hospital-Harvard · Boston, Massachusetts

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

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