Trial Information
Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Adverse events, pharmacokinetics
Outcome Time Frame:
September 2009
Safety Issue:
Yes
Principal Investigator
Andrew Roberts, Dr
Investigator Role:
Principal Investigator
Investigator Affiliation:
Melbourne Health
Authority:
United States: Food and Drug Administration
Study ID:
CSLCT-AML-06-26
NCT ID:
NCT00401739
Start Date:
December 2006
Completion Date:
September 2009
Related Keywords:
- Acute Myeloid Leukemia (AML)
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid