Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00512083




Registration number
NCT00512083
Ethics application status
Date submitted
6/08/2007
Date registered
7/08/2007
Date last updated
25/09/2009

Titles & IDs
Public title
Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia
Scientific title
An Open Label Randomized Controlled Dose Escalating Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
Secondary ID [1] 0 0
AS1411-C-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid 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 - AS1411

Treatment: Drugs: AS1411
AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- primary refractory or relapsed AML

- confirmed diagnosis of AML (de novo or secondary) as defined by WHO classification
(Vardiman 2002)

- aged at least 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- initial diagnosis of acute promyelocytic leukemia as defined by
French-American-British criteria (Bennett 1976)

- patient in blast crisis stage of chronic myeloid leukemia

- received high-dose cytarabine (total cumulative dose of >6g/m sq)in last 6 months

- interval of <6 months between first onset of last complete remission and current
relapse

- those with primary refractory leukemia who have received more than three previous
induction cycles

- relapsed patients who have received more than three previous treatment regimens

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 2
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
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
New Zealand
State/province [10] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Antisoma Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of
doses, when combined with cytarabine, in the treatment of patients with primary refractory or
relapsed acute myeloid leukemia (AML).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00512083
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT00512083