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

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia (AML)
• Interventions: Drug: CSL360

• Registration Number: NCT00401739
• Lead Sponsor: CSL Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-16
• Study First Submitted QC: 2006-11-16
• Study First Posted: 2006-11-20
• Study Start: 2006-12
• Status Verified: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I	CSL360	Treatment with CSL360

Primary Outcome Measures

Name	Time	Method
Adverse events, pharmacokinetics	September 2009

Secondary Outcome Measures

Name	Time	Method
Maximum tolerated dose	September 2009
Partial, complete and overall response	September 2009
Biological activity	September 2009

Trial Locations

Locations (6)

Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, 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

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia