Experimental combo aims to boost leukemia remission
NCT ID NCT05558124
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing the safety of combining two drugs—Vyxeos and gemtuzumab ozogamicin—for adults newly diagnosed with acute myeloid leukemia. Researchers want to find the best dose that doesn't cause severe side effects. The study will also look at how many patients achieve complete remission. Only 18 people aged 18 to 70 are being enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vyxeos (a chemotherapy drug combo) and gemtuzumab ozogamicin (a targeted antibody-drug)
- What this could lead to
- If it works, this could point toward a more effective treatment for newly diagnosed acute myeloid leukemia.
- What could go wrong
- This is a very early, small Phase 1 trial with only 18 participants. The main goal is safety, not proof of effectiveness. Side effects from the chemotherapy combination could be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
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