IRB #

STUDY00020531

Title

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

Principal Investigator

Laura Newell

Study Purpose

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.

Medical Condition(s)

Acute Myeloid Leukemia (AML)

Eligibility Criteria

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.

Age Range

18 - n/a

Healthy Volunteers Needed

No

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.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Jazz Pharmaceuticals Inc.

Recruitment End

12/31/2029

Compensation Provided

No


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