CLINICAL TRIAL SUMMARY

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
Treatment Agent:CPX-351
Study Status:Open
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.

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Disease Group:Leukemia
Phase of Study:Phase III
Treatment Agents:CPX-351
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:Celator Pharmaceuticals, Inc.
Return Visit:
Home Care:


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Physician Name:Jorge Cortes
Dept:Leukemia
For Clinical Trial Enrollment:713-794-5783
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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