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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/NCT01632852




Registration number
NCT01632852
Ethics application status
Date submitted
29/06/2012
Date registered
3/07/2012
Date last updated
9/10/2015

Titles & IDs
Public title
A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission
Scientific title
A Phase 1 Study of CSL362 (Anti-IL3Ra / Anti-CD123 Monoclonal Antibody) in Patients With CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission With Incomplete Platelet Recovery at High Risk for Early Relapse
Secondary ID [1] 0 0
CSLCT-AML-11-73
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 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
Other interventions - CSL362

Experimental: CSL362 - See Intervention Description


Other interventions: CSL362
CSL362 is humanized monoclonal antibody that targets the alpha chain of the interleukin 3 receptor (IL3Ra; also known as CD123) and is optimised for enhanced activation of antibody-dependent cell-mediated cytotoxicity (ADCC) via natural killer cells.
CSL362 is a sterile solution for injection and will be administered by intravenous infusion to subjects in sequential, escalating dose level cohorts, at doses up to 12.0 mg/kg. CSL362 will be administered every 14 days for a total of 6 infusions per subject. The 6 infusions for each individual subject will contain the same dose of CSL362.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency and Severity of Adverse Events (AEs)
Timepoint [1] 0 0
From the first treatment (Day 1) up to approximately Day 106
Primary outcome [2] 0 0
Dose-limiting toxicity (DLT) evaluation
Timepoint [2] 0 0
From the first treatment (Day 1) up to approximately Day 106
Secondary outcome [1] 0 0
Pharmacokinetic (PK) Parameters
Timepoint [1] 0 0
Before each infusion and: at 6 time points within a week after infusion 1, at 1 time point within a week after infusions 2 to 5, at 5 time points within a week after infusion 6, and once at the final visit, approximately 5 weeks after infusion 6
Secondary outcome [2] 0 0
Number of subjects developing antibodies against CSL362
Timepoint [2] 0 0
From the first treatment (Day 1) up to approximately Day 106

Eligibility
Key inclusion criteria
- Male or female aged 18 years or older.

- Previous diagnosis of CD123+ acute myeloid leukemia (AML), de novo or secondary.

- Completed and recovered from all planned induction and consolidation therapy according
to the institution's standard of care, and achieved a complete remission (CR)/CR with
incomplete platelet recovery (CRp); either first or second CR.

- Has factors conferring high risk of relapse.

- No plans for additional post-remission chemotherapy.

- Not currently a candidate for allogeneic hematopoietic stem cell transplant (HSCT).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of acute promyelocytic leukemia (APL).

- Known leukemic involvement of the central nervous system.

- Life expectancy 4 months or less as estimated by the investigator.

- Concurrent treatment or planned treatment with other anticancer therapy (chemotherapy,
immunotherapy, radiotherapy, targeted therapy, gene therapy).

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CSL Limited
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a first in human, prospective, multicenter, nonrandomized, open-label,
dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and
immunogenicity of repeat doses of CSL362.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01632852
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr. Mark DeWitte
Address 0 0
CSL Limited
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/NCT01632852