Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00401739
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : September 16, 2009
Information provided by:
CSL Limited

November 16, 2006
November 20, 2006
September 16, 2009
December 2006
September 2009   (Final data collection date for primary outcome measure)
Adverse events, pharmacokinetics [ Time Frame: September 2009 ]
Adverse events, pharmacokinetics
Complete list of historical versions of study NCT00401739 on Archive Site
  • Maximum tolerated dose [ Time Frame: September 2009 ]
  • Partial, complete and overall response [ Time Frame: September 2009 ]
  • Biological activity [ Time Frame: September 2009 ]
  • Maximum tolerated dose
  • Partial, complete and overall response
  • Biological activity
Not Provided
Not Provided
Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia
Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia
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.
Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myeloid Leukemia (AML)
Drug: CSL360
Weekly IV Infusion. Dose escalation study.
Experimental: I
Treatment with CSL360
Intervention: Drug: CSL360
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2009
September 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Dr Russell Basser, CSL Limited
CSL Limited
Not Provided
Principal Investigator: Andrew Roberts, Dr Melbourne Health
CSL Limited
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP