Phase II Study of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Patients with Newly Diagnosed AML at High Risk for Induction Mortality
The goal of this clinical research study is to compare different dose levels of CPX-351. The safety and efficacy of the drug will be studied in all dose levels.
Treatment Location: N/A
Primary Objectives The primary objective of this study is to assess preliminary efficacy (as determined by the rate of CR or CRi) of two or three dose levels of CPX-351 in patients with newly diagnosed AML at high risk for induction mortality, defined as 30-50% predicted risk of death by Day 60, and to select the most promising dose level for further efficacy testing. Estimation of risk for induction mortality at patient screening will be based on factors associated with lower likelihood of AML response with or without factors that reduce tolerance to treatment-associated adverse events. Secondary Objectives To confirm the rate of dose limiting toxicities, including induction mortality (at day 60) for two different sub-MTD dose levels (50 and 75 U/m2). If safety results suggest feasibility to test the MTD dose level of CPX-351 (100 U/m2) in patients believed to be at high risk for induction mortality, the rate of dose limiting toxicities and induction mortality will be tested in this group as well. Exploratory Objectives To investigate the effect of CPX-351 on immune response, as determined by the effect on recovery of functional pathogen-specific and leukemia-specific immune responses and the recovery and function of NK cells. To investigate the role of Troponin-T as an early marker for CPX-351-induced cardiotoxicity. To investigate ex vivo the cytotoxicity of combination of Pim kinase inhibitor(s) and CPX-351 on circulating leukemia cells.
IRB Review and Approval Date: 05/04/2015
Recruitment Status: Closed
Projected Accrual: N/A
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