Trials / Completed
CompletedNCT00401739
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- CSL Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CSL360 | Weekly IV Infusion. Dose escalation study. |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2009-09-01
- Completion
- 2009-09-01
- First posted
- 2006-11-20
- Last updated
- 2009-09-16
Locations
6 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT00401739. Inclusion in this directory is not an endorsement.