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Therapeutic Areas: Oncology | Hematology
Disease Category: Acute Myelogenous Leukemia (AML)

Trial Information

Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients = 60 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration

The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens.

The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.

Patient Inclusion Criteria:

• Age =18 and =60 years at the time of relapse
• Pathological confirmation of relapsed AML after initial CR of >1 month duration
• Cardiac ejection fraction > 50% by echocardiography or MUGA scan

Patient Exclusion Criteria:

• Patients with locally advanced or metastatic solid tumors =5 years from initial diagnosis are excluded. (Patients with locally advanced or metastatic solid tumors >5 years from initial diagnosis, for whom the investigator has no clinical suspicion of active disease for >2 years before randomization are eligible)
• Administration of any antineoplastic therapy within 4 weeks of therapy; intended to treat first relapse. In the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment
• Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in New York Heart Association Class III or IV staging

Cathy Spears, Research Manager
St. Francis Hospital and Health Centers
1500 N Albany Street, Suite 1001
Beech Grove, IN 46107
Phone: 317-782-7819
Fax: 317-782-7828
EMail: cathy.spears@ssfhs.org

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