A Phase 1b trial of CPX-351 Lower Intensity Therapy (LIT) plus Venetoclax as First Line Treatment for Subjects with AML who are Unfit for Intensive Chemotherapy
The purpose of the study is to find out whether a reduced dosing of CPX-351 (a drug marketed as Vyxeos), given in combination with Venetoclax, is safe and effective when given to patients with newly diagnosed Acute Myeloid Leukemia (AML) who cannot tolerate intensive chemotherapy due to age or other health conditions.
This study will also assess the pharmacokinetic (the level of drugs within the body) of CPX-351 and Venetoclax when the two drugs are given together.
Acute Myeloid Leukemia (AML)
Eligible subjects must meet the following:
-Newly diagnosed with AML, AND
-Be 75 years of age or older, OR
-Be 18 to 74 years of age and at least one 1 criteria associated with: performance status, heart health, breathing capacity, kidney function, liver function, or other medical conditions determined by the investigator that may not be compatible with conventional intensive chemotherapy.
18 - n/a
Healthy Volunteers Needed
Duration of Participation
Study participation will be approximately 1 year. Up to 4 cycles of study intervention can be given as determined by the investigator. Subjects will be followed for safety 1 month after the end of treatment/early termination.
Clinical Trials Information Line
Jazz Pharmaceuticals Inc.