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

• Sponsor: CSL Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00401739
• Collaborator: (none)
• Enrollment: 40
• Locations: 6
• Arm: 1
• Duration (Months): 33
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia (AML)	Drug: CSL360	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I Treatment with CSL360	Drug: CSL360; Weekly IV Infusion. Dose escalation study.

Outcome Measures

Primary Outcome Measures

1. Adverse events, pharmacokinetics [September 2009]

Secondary Outcome Measures

1. Maximum tolerated dose [September 2009]

2. Partial, complete and overall response [September 2009]

3. Biological activity [September 2009]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westmead Hospital	Westmead	New South Wales	Australia	2145
2	Royal Brisbane and Women's Hospital	Brisbane	Queensland	Australia	4029
3	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
4	Institute of Medical & Veterinary Science	Adelaide	South Australia	Australia	5000
5	Peter MacCallum Cancer Institute	Melbourne	Victoria	Australia	3002
6	Royal Melbourne Hospital	Melbourne	Victoria	Australia	3052

Sponsors and Collaborators

• CSL Limited

Investigators

• Principal Investigator: Andrew Roberts, Dr, Melbourne Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00401739
• Other Study ID Numbers: CSLCT-AML-06-26
• First Posted: Nov 20, 2006
• Last Update Posted: Sep 16, 2009
• Last Verified: Sep 1, 2009

• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Sep 16, 2009