Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia

Acute Myeloid Leukemia (AML) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401739
• Other study ID #: CSLCT-AML-06-26
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2006
• Last updated: September 14, 2009
• Start date: December 2006
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: CSL Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• CSL360
Weekly IV Infusion. Dose escalation study.

Locations

Country	Name	City	State
Australia	Institute of Medical & Veterinary Science	Adelaide	South Australia
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Peter MacCallum Cancer Institute	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
CSL Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, pharmacokinetics		September 2009	Yes
Secondary	Maximum tolerated dose		September 2009	Yes
Secondary	Partial, complete and overall response		September 2009	No
Secondary	Biological activity		September 2009	No