CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0603 (clinicaltrials.gov NCT No: NCT00788892)
Title:Phase IIB, Multicenter, Randomized, Open Label Trial of CPX-351 (Cytarabine: Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients with Untreated AML 60 - 75 years of Age
Principal Investigator:Jorge Cortes
Treatment Agent:CPX-351
Study Status:Closed
Study Description:The goal of this clinical research study is to learn if a combination of
cytarabine and daunorubicin that is called CPX-351 can help to control AML.
Researchers also want to compare the effectiveness of the administration of the
2 drugs in this combination to the standard administration of the combination.

The safety of this drug combination will also be studied.

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Disease Group:Leukemia
Phase of Study:Phase II
Treatment Agents:CPX-351
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:None anticipated; however, will admit to hematology beds if the patient is
admitted for adverse reactions or suspected side effects from this agent.
Supported By:Celator Pharmaceuticals, Inc.
Return Visit:At least once weekly during first month, then at least at the start of each
cycle.
Home Care: None


Hide details for Study Contact InformationStudy Contact Information

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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