A Phase II Study of CPX-351 in Younger Patients < 60 Years Old With Secondary Acute Myeloid Leukemia

Description

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.PRIMARY OBJECTIVE: I. To determine the complete response rate including morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) as defined by the International Working Group Criteria. SECONDARY OBJECTIVE: I. To determine CR + CRi duration, event free survival (EFS), overall survival (OS), patients successfully proceeding to allogenic hematopoietic cell transplant, and adverse events (AE). OUTLINE: INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV) over 90 minutes on days 1, 3, and 5 in the absence

Trial Eligibility

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

Study Info

Interventions

Locations Recruiting

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