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 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Given IV
University of Nebraska Medical Center
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
SUNY Upstate Medical Center
Syracuse, New York, United States
Allegheny Health Network Cancer Institute - West Penn Hospital
Pittsburgh, Pennsylvania, United States
Complete response rate (morphological complete remission [CR] and incomplete blood count recovery [CRi])
Defined by the International Working Group Criteria. Will be summarized using frequencies and relative frequencies.
Time frame: At day 45
CR + CRi duration
Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
Time frame: Time from CR or CRi until relapse or last follow-up, assessed up to 5 years
Event free survival
Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
Time frame: Time from treating until disease progression/relapse, death due to disease, or last follow-up, assessed up to 5 years
Overall survival
Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
Time frame: Time from treatment until death due to any cause or last follow-up, assessed up to 5 years
Allogeneic hematopoietic cell transplant rate
Transplant rate estimated using a 90% confidence interval obtained using Jeffrey's prior method.
Time frame: Up to 5 years
Incidence of adverse events
Will be reported by grade using frequencies and relative frequencies.
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.