OncoMatch/Clinical Trials/NCT05558124
CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML
Is NCT05558124 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Other
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)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05558124 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD33?
Yes, CD33 expression is a required biomarker for enrollment.
Does this trial require FLT3?
Yes, FLT3 ITD mutation is a required biomarker for enrollment.
Does this trial require FLT3?
Yes, FLT3 TKD mutation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
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 qualifyRelated pages