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

• Status: Recruiting
• Trial end date: 2023-09-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cytarabine; Daunorubicin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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