Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Treatment with CSL360 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL360 | Drug | Weekly IV Infusion. Dose escalation study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, pharmacokinetics | September 2009 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | September 2009 | |
| Partial, complete and overall response | September 2009 | |
| Biological activity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew Roberts, Dr | Melbourne Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia | ||
| Royal Brisbane and Women's Hospital |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000606072 | CSL360 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| September 2009 |
| 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 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |