The purpose of this study is to assess the effects of CPX-351 on cardiac repolarization, assess plasma drug levels, asses serum copper levels, and assess drug levels in urine. Efficacy and Safety will be assessed in all patients enrolled to the study.
This study is an open-label, single-arm, Phase II, PK and pharmacodynamic (PD) trial of CPX-351 in patients with documented acute leukemia (AML or ALL) or MDS (IPSS score ≥ 1.5) and suitable for treatment with intensive chemotherapy. Each patient will be screened for hepatic impairment. Hepatic impairment will be assessed using the Child-Pugh system and only patients with a Child-Pugh score \<7 points will be eligible for this study. Patients will receive up to two inductions and four consolidation courses. Patients will be monitored for safety (early deaths, adverse events, metabolic changes, etc.) and efficacy (response for AML, ALL, and MDS) while on the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Franciscan Saint Francis Health
Indianapolis, Indiana, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Oregon Health & Science University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF)
Time-matched QTcF Changes From Baseline after the start of first infusion
Time frame: 21 days
Serum Copper Levels Change From Baseline
Change from Baseline to Induction 1, Day 5
Time frame: During 1st induction (up to 5 days)
Complete Response Rate
Time frame: Following 1st induction, following 2nd induction if applicable
Tmax
Time frame: Induction 1, Day 5
Cmax
Time frame: Induction 1, Day 5
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