Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

Phase 2 Completed 126 enrolled Jazz Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

The study investigates if CPX-351 will be a) more effective than the standard AML treatment and b) more tolerable than the standard AML treatment regimens. The study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group.

Timeline

Start: 2008-10
Primary completion: 2010-06
Completion: 2011-12

Outcome

Met primary endpoint

paper Overall, CPX-351 produced higher response rates (66.7% vs 51.2%, P = .07), meeting predefined criteria for success (P < .1). PMID 24687088 ↗

Publications

Lancet JE, Cortes JE, Hogge DE, Tallman MS, Kovacsovics TJ, Damon LE, Komrokji R, Solomon SR, Kolitz JE, Cooper M, Yeager AM, Louie AC, Feldman EJ. Phase 2 trial of CPX-351, a fixed 5:1 molar ratio of cytarabine/daunorubicin, vs cytarabine/daunorubicin in older adults with untreated AML. Blood. 2014 May 22;123(21):3239-46. doi: 10.1182/blood-2013-12-540971. Epub 2014 Mar 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CPX-351	Other / unclassified	100 unknown	—
Comparator	Cytarabine	Small molecule	100 mg/m2	—
Comparator	Daunorubicin	Small molecule	45 mg/m2	—
Comparator	Daunorubicin	Small molecule	60 mg/m2	—