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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00401739




Registration number
NCT00401739
Ethics application status
Date submitted
16/11/2006
Date registered
20/11/2006
Date last updated
16/09/2009

Titles & IDs
Public title
Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia
Scientific title
Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia
Secondary ID [1] 0 0
CSLCT-AML-06-26
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia (AML) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CSL360

Experimental: I - Treatment with CSL360


Treatment: Drugs: CSL360
Weekly IV Infusion. Dose escalation study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events, pharmacokinetics
Timepoint [1] 0 0
September 2009
Secondary outcome [1] 0 0
Maximum tolerated dose
Timepoint [1] 0 0
September 2009
Secondary outcome [2] 0 0
Partial, complete and overall response
Timepoint [2] 0 0
September 2009
Secondary outcome [3] 0 0
Biological activity
Timepoint [3] 0 0
September 2009

Eligibility
Key inclusion criteria
- Clinical diagnosis of acute myeloid leukemia

- Recent bone marrow biopsy

- Prior treatment or medically unfit for standard therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Institute of Medical & Veterinary Science - Adelaide
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Institute - Melbourne
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3002 - Melbourne
Recruitment postcode(s) [6] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CSL Limited
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00401739
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Roberts, Dr
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00401739