OncoMatch/Clinical Trials/NCT05558124
CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML
Is NCT05558124 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Vyxeos and Gemtuzumab Ozogamicin for acute myeloid leukemia.
Treatment: Vyxeos · Gemtuzumab Ozogamicin — The purpose of the study is to determine the safety of combining the drugs gemtuzumab ozogamicin (GO) with CPX-351 in order to treat the disease, as well as to find the maximum tolerated dose level and recommended Phase 2 dose level of GO with a fixed dose of CPX-351.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CD33 expression
Myeloblasts expressing CD33 as determined by flow cytometry or immunohistochemistry
Required: FLT3 ITD mutation
Any patient with a known FLT3 ITD or FLT3 TKD mutation [excluded]
Required: FLT3 TKD mutation
Any patient with a known FLT3 ITD or FLT3 TKD mutation [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: AML therapy
Exception: hydroxyurea and/or leukapheresis allowed
Prior treatment of AML except hydroxyurea and/or leukapheresis
Lab requirements
Liver function
Severe liver disease (cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis) or patients with known Wilson's disease [excluded]
Cardiac function
Adequate cardiac function defined as ejection fraction of ≥50% as determined by MUGA or 2D echocardiogram; Uncontrolled cardiac disease including congestive heart failure class III or IV by the NYHA, unstable angina (angina symptoms at rest), new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months [excluded]
Participants must have acceptable organ function; Adequate cardiac function defined as ejection fraction of ≥50% as determined by multigated acquisition scan (MUGA) or 2D echocardiogram; Severe liver disease (cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis) or patients with known Wilson's disease [excluded]; Uncontrolled cardiac disease including congestive heart failure class III or IV by the NYHA, unstable angina (angina symptoms at rest), new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
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