OHSU

IRB #

IRB00009141

Title

Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age with Untreated High Risk (Secondary) Acute Myeloid Leukemia (AML).

Principal Investigator

Laura Newell

Study Purpose

The specific purpose of this study is to: Find out what effects, good and bad, the study drug, CPX-351, has on participants with newly diagnosed high risk (secondary) leukemia. To compare survival among participants with high risk (secondary) leukemia who receive the study drug with those who receive the standard treatment, “7+3”, Cytarabine and Daunorubicin.

Medical Condition(s)

Untreated High Risk (Secondary) Acute Myeloid Leukemia (AML)

Eligibility Criteria

60-75 Years of Age with Untreated High Risk (Secondary) Acute Myeloid Leukemia (AML)

Age Range

60 - 75

Healthy Volunteers Needed

No

Duration of Participation

During the first year the participant will be seen on a monthly basis in clinic. After the first year, the participant will be contacted regularly to see how their leukemia is and if they have received any new leukemia medications. The participants will be followed for up to 5 years from study randomization.

Minors Included

No

Contact

Nan Subbiah 503-494-4603

Sponsor

Celator Pharmaceuticals Inc.

Recruitment End

11/30/2025

Compensation Provided

No


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