|MDACC Study No:||2012-0980 (clinicaltrials.gov NCT No: NCT01696084)|
|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) AML|
|Principal Investigator:||Jorge Cortes|
|Study Description:||The goal of this clinical research study is to learn how effective CPX-351 may |
be in patients with high-risk leukemia. In this study, CPX-351 will be
compared to the standard-of-care combination of cytarabine and daunorubicin
(also called 7+3). This combination is called “7+3” because patients receive 7
days of cytarabine and 3 days of daunorubicin.
CPX-351 is a combination of cytarabine and daunorubicin and given by what is
called a “liposome” injection. This is a special fat capsule (called a
liposome) that surrounds the cytarabine and daunorubicin and is designed to
protect the drugs from being eliminated or destroyed by the body.
Cytarabine is designed to insert itself into DNA (genetic material) of cancer
cells and stop the DNA from repairing itself.
Daunorubicin is designed to block cancer cells from dividing, which may slow or
stop their growth and spread throughout the body. This may cause the cancer
cells to die.