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

This study has been completed.
Sponsor:
Information provided by:
CSL Limited
ClinicalTrials.gov Identifier:
NCT00401739
First received: November 16, 2006
Last updated: September 14, 2009
Last verified: September 2009

November 16, 2006
September 14, 2009
December 2006
September 2009   (final data collection date for primary outcome measure)
Adverse events, pharmacokinetics [ Time Frame: September 2009 ] [ Designated as safety issue: Yes ]
Adverse events, pharmacokinetics
Complete list of historical versions of study NCT00401739 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00401739
CSLCT-AML-06-26
No
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