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) AML (protocol CLTR0310-301)

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women who are newly diagnosed with high risk (secondary) Acute Myeloid Leukemia (AML), have not received any treatment for the disease and are between the ages of 60 to 75.

The purpose of the study is to confirm the effectiveness of the experimental drug CPX-351 as a first line therapy for high risk (secondary) AML in older people, compared to the currently used combination treatment (“7+3”).

CPX-351 is a combination of two anti-tumor drugs, Cytarabine and Daunorubicin. This study will use a “liposome” injection; this is a fat capsule (liposome) that surrounds the Cytarabine and Daunorubicin and protects the drugs from being eliminated/destroyed by the body.

7+3, the currently used combination treatment, also combines Cytarabine and Daunorubicin. It is called 7+3 because people receive 7 days of continuous infusion of Cytarabine and infusions of Daunorubicin on days 1, 2 and 3.

Study participants will be randomly assigned to one of two treatment arms:

  •  Arm A: CPX-351
  •  Arm B: 7+3

Participants may be treated with up to 2 induction cycles of CPX-351 or 7+3. If a participant’s disease is in remission after two induction cycles, he/she may receive up to 2 more treatment cycles (consolidation therapy).

Once treatment is completed, participants will have follow-up visits once a month for a year after starting the study, and then will be followed for up to 5 years after entering the study. 

Disease Status and/or Stage

Newly Diagnosed High Risk AML, Age 60 to 75



Key Eligibility

  • Men and women age 60 to 75
  • Diagnosed with high-risk AML
  • No prior induction therapy for AML
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Eric Feldman, MD


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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