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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

Organization

Roswell Park Cancer Institute


Primary Outcome

Complete response rate (morphological complete remission [CR] and incomplete blood count recovery [CRi])


Outcome Timeframe At day 45

NCTID NCT04269213

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2021-07-29

Completion Date 2025-01-29

Enrollment Target 12

Interventions

DRUG Liposome-encapsulated Daunorubicin-Cytarabine

Locations Recruiting

University of Nebraska Medical Center

United States, Nebraska, Omaha


Roswell Park Cancer Institute

United States, New York, Buffalo


SUNY Upstate Medical Center

United States, New York, Syracuse


Allegheny Health Network Cancer Institute - West Penn Hospital

United States, Pennsylvania, Pittsburgh


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