Ph 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients With AML

Phase 1 Terminated 23 enrolled Polaris Group

NaSingle-groupOpen-labelTreatment

Summary

Assessment of safety and tolerability of drug combination and determine time on treatment, Overall survival (OS) and response rate with patient disease burden, and type of disease

Timeline

Start: 2017-01-20
Primary completion: 2019-07-10
Completion: 2019-07-10

Publications

Tsai HJ, Hsiao HH, Hsu YT, Liu YC, Kao HW, Liu TC, Cho SF, Feng X, Johnston A, Bomalaski JS, Kuo MC, Chen TY. Phase I study of ADI-PEG20 plus low-dose cytarabine for the treatment of acute myeloid leukemia. Cancer Med. 2021 May;10(9):2946-2955. doi: 10.1002/cam4.3871. Epub 2021 Mar 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pegargiminase	Protein / enzyme biologic	18 mg/m2	Intramuscular
Subject	Pegargiminase	Protein / enzyme biologic	36 mg/m2	Intramuscular
Background	Cytarabine	Small molecule	20 mg	Subcutaneous

Ph 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients With AML

Summary

Timeline

Publications

Drugs

Indications