Acute Myeloid Leukemia Clinical Trial
CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old
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.
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.
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).
INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV) over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity.
RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, and then every 3 months for up to 5 years.
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
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
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