A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351

Inclusion criteria

• Ability to understand and voluntarily give informed consent.
• Male or female patients, age ≥18 years at the time of consent.
• Diagnosis of hematologic malignancy including, but not limited to, AML, ALL, and MDS. Patients may be newly diagnosed, refractory to initial treatment, or in relapse.
• Patients with normal renal function, or moderate or severe renal impairment as categorized by creatinine clearance (CrCl)) using the Cockcroft-Gault Formula.
• Consent of female patients to use a medically acceptable method of contraception for at least 2 months prior to the first dose of CPX-351 and consent of female patients to use a medically acceptable method of contraception throughout the entire study period and for 6 months following the last dose of CPX-351.
• Male patients must be willing to refrain from sperm donation for 6 months following the last dose of CPX-351and must use adequate contraception throughout the entire study period and for 6 months following the last dose of CPX-351.

Exclusion criteria

• Prior treatment with CPX-351 ≤ to 1 month before the start of CPX-351 in this study.
• Patients with active (uncontrolled, metastatic) second malignancies are excluded.
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent obtaining informed consent.
• Patients with known hypersensitivity to cytarabine, daunorubicin, or liposomal products.
• Female patients who are pregnant, nursing, or lactating.
• Participation in another clinical trial of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to enrollment in this study.
• Any other condition that would cause a risk to patients if they participate in the trial.