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
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia

Resource links provided by NLM:


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
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier: NCT00401739     History of Changes
Other Study ID Numbers: CSLCT-AML-06-26
Study First Received: November 16, 2006
Last Updated: September 14, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014