This phase II trial studies how well CPX-351 works in treating patients with acute lymphoblastic leukemia that has come back or does not respond to treatment. CPX-351 is combination of two chemotherapy drugs called cytarabine and daunorubicin which are protected inside fat particles called liposomes to help prevent these drugs from being eliminated/destroyed by the body. 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03575325.
PRIMARY OBJECTIVE:
I. To estimate the complete response rate following treatment with liposome-encapsulated daunorubicin-cytarabine (CPX-351).
SECONDARY OBJECTIVES:
I. To evaluate safety and tolerability of CPX-351 using Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
II. Minimal residual disease assessment (MRD) by 10 color flow cytometry and next generation sequencing (NGS) by Clonoseq (for Philadelphia negative leukemia) or polymerase chain reaction (PCR) for BCR-ABL (for Philadelphia positive leukemia).
III. Progression free survival as defined by Cheson criteria, namely progression, failure to respond, or death, as assessed from time of first treatment.
IV. Overall survival as defined by Cheson criteria, namely death due to any cause as assessed from time of first treatment.
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.
CONSOLIDATION: Within 28-75 days after day 1 of induction, patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days on 1 and 3. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at day 30, then periodically thereafter.
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorBijal D. Shah
