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New treatment option for Acute Myeloid Leukemia
Official title CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML
ClinicalTrials.gov ID: NCT05558124
What this study is testing
What is Vyxeos?
Vyxeos is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as daunorubicin-cytarabine, CPX-351.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- The effects of CPX-351 and gemtuzumab ozogamicin on the developing human fetus are unknown. For this reason, women of child-bearing potential as...
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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
- 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...
- Hemodynamically unstable (people 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...
- 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 how well it works, or...
- Female subject who is pregnant or breastfeeding.
- Any patient with a known FLT3 ITD or FLT3 TKD mutation
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.