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

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia (AML) Drug: CSL360 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia
Study Start Date : December 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: I
Treatment with CSL360
Drug: CSL360
Weekly IV Infusion. Dose escalation study.

Primary Outcome Measures :
  1. Adverse events, pharmacokinetics [ Time Frame: September 2009 ]

Secondary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: September 2009 ]
  2. Partial, complete and overall response [ Time Frame: September 2009 ]
  3. Biological activity [ Time Frame: September 2009 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00401739

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
Peter MacCallum Cancer Institute
Melbourne, Victoria, Australia, 3002
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3052
Sponsors and Collaborators
CSL Limited
Principal Investigator: Andrew Roberts, Dr Melbourne Health

Responsible Party: Dr Russell Basser, CSL Limited Identifier: NCT00401739     History of Changes
Other Study ID Numbers: CSLCT-AML-06-26
First Posted: November 20, 2006    Key Record Dates
Last Update Posted: September 16, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type