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CPX-351 with Gemtuzumab Ozogamicin for Newly Diagnosed AML

This study is testing a new way to treat newly diagnosed Acute Myeloid Leukemia (AML), a type of blood cancer. It combines two drugs: CPX-351 (Vyxeos) and Gemtuzumab Ozogamicin (GO). Researchers want to find the safest and most effective dose of Gemtuzumab Ozogamicin when given with a standard dose of CPX-351. They will be looking for the highest dose that patients can tolerate well. The study plans to enroll 18 participants between 18 and 70 years old who have newly diagnosed AML. The main goal is to find the maximum tolerated dose of the drug combination within 18 months.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 18 participants to test different dose levels of Gemtuzumab Ozogamicin.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Maximum Tolerated Dose, is measured for up to 18 months.

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NCT05558124

CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML

Recruiting
PHASE1Ages 18–70InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~18 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:VyxeosGemtuzumab Ozogamicin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD)
Measured over Up to 18 Months

Conditions

Acute Myeloid Leukemia

Explore related trials

Acute Myeloid LeukemiaCD33 Gene

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Onyee Chan, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Lisa Nardelli
[email protected]
1-813-745-4731
Email the study team

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged ≥18 and ≤70 years with newly diagnosed any risk AML as defined by ELN 2017 criteria
For females of child-bearing potential: use of highly effective contraception upon enrollment and during study participation and for an additional 6 months after the end of CPX-351 and Gemtuzumab ozogamicin administration: A female of child-bearing potential is considered when a sexually mature female: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months
The effects of CPX-351 and gemtuzumab ozogamicin on the developing human fetus are unknown. For this reason, women of child-bearing potential as defined above must have a negative serum or urine pregnancy test within 24 hours prior to beginning study treatment.
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
Myeloblasts expressing CD33 as determined by flow cytometry or immunohistochemistry
ECOG ≤ 2 and eligible to receive intensive chemotherapy as determined by the treating physician
Prior malignancy is allowed providing it does not require concurrent therapy. Exception: Active hormonal therapy is allowed.
Prior hypomethylating agents (HMA) therapy including azacitidine or decitabine when used for non-AML diagnoses is allowed. Most recent dose must have been ≥14 days prior to day 1 of study treatment.
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.
Hydroxyurea is allowed for cytoreduction until day 1 of study treatment

Exclusion

Prior treatment of AML except hydroxyurea and/or leukapheresis
Participants with acute promyelocytic leukemia (APL).
Known current and clinically active central nervous system (CNS) leukemia.
Severe liver disease (cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis) or patients with known Wilson's disease.
Participants with known active infection with hepatitis B or hepatitis C virus
Known allergic reactions to components of the CPX-351 (cytarabine or daunorubicin) or Gemtuzumab ozogamicin.
Patients with any prior anthracycline exposure plus any planned on-study anthracycline exposure cannot not exceed 550 mg/m2 of daunorubicin (or equivalent). For participants who have received radiation therapy to the mediastinum, the total cumulative dose of anthracycline should not exceed 400 mg/m2 of daunorubicin(or equivalent).
Hemodynamically unstable (subjects requiring vasopressor support will not be eligible).
Treatment with another investigational drug within 14 days.
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.
Any disorder that compromises the subject's ability to give written informed consent and/or to comply with study procedures.
Any substance abuse, severe and/or uncontrolled medical, social or psychiatric conditions that may prevent the subject from completing the study, interfere with the evaluation of safety and/or efficacy, or interfere with the interpretation of the study results.
Female subject who is pregnant or breastfeeding.
Any patient with a known FLT3 ITD or FLT3 TKD mutation

What this trial measures

  • Maximum Tolerated Dose (MTD)Up to 18 Months

    Dose escalation will determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Vyxeos plus Gemtuzumab Ozogamicin. The MTD is the highest dose of the combination therapy that dose not cause unacceptable side effects.