CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old
- Conditions
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeAcute Myeloid Leukemia With Myelodysplasia-Related ChangesSecondary Acute Myeloid LeukemiaTherapy-Related Acute Myeloid Leukemia
- Interventions
- Drug: Liposome-encapsulated Daunorubicin-Cytarabine
- Registration Number
- NCT04269213
- Lead Sponsor
- Roswell Park Cancer Institute
- Brief 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.
- Detailed Description
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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 46
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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])
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Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
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Plasma creatinine =< 1.5 x upper limit of normal (ULN)
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Total bilirubin < 2.0 mg/dL
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Serum alanine aminotransferase and aspartate aminotransferase < 3 x ULN
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Left ventricular ejection fraction by echocardiogram or multiple-gated acquisition >= 50%
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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
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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
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Men must use a latex condom during any sexual contact with women of childbearing potential
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Willing to adhere to protocol specific requirements
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (CPX-351) Liposome-encapsulated Daunorubicin-Cytarabine INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine 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.
- Primary Outcome Measures
Name Time Method Complete response rate (morphological complete remission [CR] and incomplete blood count recovery [CRi]) At day 45 Defined by the International Working Group Criteria. Will be summarized using frequencies and relative frequencies.
- Secondary Outcome Measures
Name Time Method Event free survival Time from treating until disease progression/relapse, death due to disease, or last follow-up, assessed up to 5 years Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
Incidence of adverse events Up to 5 years Will be reported by grade using frequencies and relative frequencies.
Overall survival Time from treatment until death due to any cause or last follow-up, assessed up to 5 years Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
CR + CRi duration Time from CR or CRi until relapse or last follow-up, assessed up to 5 years Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
Allogeneic hematopoietic cell transplant rate Up to 5 years Transplant rate estimated using a 90% confidence interval obtained using Jeffrey's prior method.
Trial Locations
- Locations (4)
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
SUNY Upstate Medical Center
🇺🇸Syracuse, New York, United States
Allegheny Health Network Cancer Institute - West Penn Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States