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Brief Title: Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia
Official Title: Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia
Study ID: NCT00401739
Brief Summary: Acute myeloid leukemia (AML) is a heterogeneous group of diseases characterized by uncontrolled proliferation of the myeloid line of white blood cells and impaired production of normal blood cells. If untreated, patients die of infection or bleeding usually in a matter of weeks. CSL360 is a neutralising monoclonal antibody which is believed to target the cells that are thought to drive AML but that are not effectively killed by standard treatment. The aims of the study are to determine a biologically active dose of CSL360 and generate understanding of a rational schedule of administration for future studies.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Westmead Hospital, Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Institute of Medical & Veterinary Science, Adelaide, South Australia, Australia
Peter MacCallum Cancer Institute, Melbourne, Victoria, Australia
Royal Melbourne Hospital, Melbourne, Victoria, Australia
Name: Andrew Roberts, Dr
Affiliation: Melbourne Health
Role: PRINCIPAL_INVESTIGATOR