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
1 other identifier
interventional
40
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2006
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2006
CompletedFirst Posted
Study publicly available on registry
November 20, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedSeptember 16, 2009
September 1, 2009
2.8 years
November 16, 2006
September 14, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events, pharmacokinetics
September 2009
Secondary Outcomes (3)
Maximum tolerated dose
September 2009
Partial, complete and overall response
September 2009
Biological activity
September 2009
Study Arms (1)
I
EXPERIMENTALTreatment with CSL360
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of acute myeloid leukemia
- Recent bone marrow biopsy
- Prior treatment or medically unfit for standard therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Limitedlead
Study Sites (6)
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Institute of Medical & Veterinary Science
Adelaide, South Australia, 5000, Australia
Peter MacCallum Cancer Institute
Melbourne, Victoria, 3002, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3052, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Roberts, Dr
Melbourne Health
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 16, 2006
First Posted
November 20, 2006
Study Start
December 1, 2006
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
September 16, 2009
Record last verified: 2009-09