Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia - Full Text View

Sponsored by:	CSL Limited
Information provided by:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00401739

Purpose

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.

Condition	Intervention	Phase
Acute Myeloid Leukemia (AML)	Drug: CSL360	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Further study details as provided by CSL Limited:

Primary Outcome Measures:

Adverse events, pharmacokinetics [ Time Frame: September 2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Maximum tolerated dose [ Time Frame: September 2009 ] [ Designated as safety issue: Yes ]
Partial, complete and overall response [ Time Frame: September 2009 ] [ Designated as safety issue: No ]
Biological activity [ Time Frame: September 2009 ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	December 2006
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Treatment with CSL360	Drug: CSL360 Weekly IV Infusion. Dose escalation study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of acute myeloid leukemia
Recent bone marrow biopsy
Prior treatment or medically unfit for standard therapy

Exclusion Criteria:

Peripheral blood blast count > 30 x 109/L, or rapidly progressive AML
Previous solid organ transplant
Active GvHD or immunosuppression
Concurrent treatment with other anti-cancer therapy
Active infections

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401739

Locations

Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Institute of Medical & Veterinary Science
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3052
Peter MacCallum Cancer Institute
Melbourne, Victoria, Australia, 3002

Sponsors and Collaborators

CSL Limited

Investigators

Principal Investigator:

Andrew Roberts, Dr

Melbourne Health

More Information

No publications provided

Responsible Party:	CSL Limited ( Dr Russell Basser )
Study ID Numbers:	CSLCT-AML-06-26
Study First Received:	November 16, 2006
Last Updated:	June 22, 2009
ClinicalTrials.gov Identifier:	NCT00401739 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Leukemia
Acute Myelocytic Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Leukemia, Myeloid
Leukemia, Myeloid, Acute

ClinicalTrials.gov processed this record on September 03, 2009