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

Launched by ROSWELL PARK CANCER INSTITUTE · Feb 11, 2020

Keywords

ClinConnect Summary

This clinical trial, called CPX-351, is looking at a new treatment option for patients under 60 years old who have secondary acute myeloid leukemia (AML). This type of leukemia can develop from other blood disorders or as a result of previous cancer treatments. The study will test a special chemotherapy drug called CPX-351, which combines two medications that help stop cancer cells from growing and spreading. Researchers want to see how effective this treatment is for these patients.

To participate in this trial, patients must be newly diagnosed with specific types of secondary AML and have certain health criteria, including a good overall health status. They should not have received any previous treatments for AML and must meet various safety requirements, such as normal kidney and liver function. If someone joins the trial, they can expect regular check-ups and monitoring during their treatment to ensure their safety. It's important for potential participants to understand that women who can become pregnant must use birth control during the study, and everyone will need to provide informed consent before starting any procedures. This trial is currently recruiting participants, so it's a great opportunity for eligible patients to explore a new treatment option.

Gender

ALL

Eligibility 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