Acute Myeloid Leukemia (AML)
Conditions
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.
Interventions
DRUGCSL360
Weekly IV Infusion. Dose escalation study.
Sponsors
CSL Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, pharmacokinetics | September 2009 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose | September 2009 |
| Partial, complete and overall response | September 2009 |
| Biological activity | September 2009 |
Countries
Australia
Outcome results
None listed