CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old

Running, not enrolling · Phase 2

Conditions studied: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia

In brief

This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine (CPX-351) works in treating patients with secondary acute myeloid leukemia who are younger than 60 years old. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Key facts

Study ID

NCT04269213

Run by

Roswell Park Cancer Institute

People needed

21

Starts

2021-07-29

Expected to finish

2027-01-29

Last updated by the study team

2025-12-23

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed:
• Therapy-related acute myeloid leukemia (AML)
• AML with antecedent myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
• AML with MDS-related changes (as per World Health Organization [WHO])
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
• Plasma creatinine =< 1.5 x upper limit of normal (ULN)
• Total bilirubin < 2.0 mg/dL
• Serum alanine aminotransferase and aspartate aminotransferase < 3 x ULN
• Left ventricular ejection fraction by echocardiogram or multiple-gated acquisition >= 50%
• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and commit to two forms of birth control
• Men must use a latex condom during any sexual contact with women of childbearing potential
• Willing to adhere to protocol specific requirements
• Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

You may not qualify if…

• Prior treatment of AML
• Known clinically active central nervous system (CNS) leukemia
• Core-binding factor leukemia
• Acute promyelocytic leukemia
• Uncontrolled other malignancy
• Prior anthracycline exposure > 368 mg/m\^2 of daunorubicin or equivalent
• Cardiovascular disease resulting in heart failure (New York Heart Association class III or IV), unstable angina (angina symptoms at rest), or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
• Hypersensitivity to cytarabine, daunorubicin, or liposomal drugs
• Known active HIV infection
• Known history of active hepatitis B or C infection
• Pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)
• Evidence of ongoing, uncontrolled systemic infection
• Pregnant or breastfeeding women
• Subject with concurrent severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy
• History of Wilson disease or other copper-handling disorders
• Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Where it is running

• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• SUNY Upstate Medical Center — Syracuse, New York, United States
• Allegheny Health Network Cancer Institute - West Penn Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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