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Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia (AML)

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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

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