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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01034410




Registration number
NCT01034410
Ethics application status
Date submitted
16/12/2009
Date registered
17/12/2009
Date last updated
2/02/2011

Titles & IDs
Public title
A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
Scientific title
An Open-label Randomized Controlled 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-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 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 - Cytarabine

Active comparator: Control - cytarabine 2g/m2 bid Days 4-7

Experimental: AS1411-40 - AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7

Experimental: AS1411-80 - AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7


Treatment: Drugs: AS1411
AS1411 40mg/kg/day or AS1411 80mg/kg/day

Treatment: Drugs: Cytarabine
Cytarabine 2g/m2 bid Days 4-7
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare the response rate (CR + CRi) of AS1411 at 40 and 80mg/kg/day in combination with cytarabine therapy with the response rate (CR + CRi) of cytarabine therapy alone
Timepoint [1] 0 0
Dec 2011
Secondary outcome [1] 0 0
To compare duration of remission, disease free survival and overall survival of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
Timepoint [1] 0 0
Dec 2011
Secondary outcome [2] 0 0
To compare the time to hematological recovery of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
Timepoint [2] 0 0
Dec 2011
Secondary outcome [3] 0 0
To compare the safety of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
Timepoint [3] 0 0
Dec 2011
Secondary outcome [4] 0 0
To evaluate and compare a range of PD markers in patients administered AS1411 in combination with cytarabine therapy with the same PD markers in patients administered cytarabine therapy alone.
Timepoint [4] 0 0
Dec 2011
Secondary outcome [5] 0 0
To further define the PK of AS1411
Timepoint [5] 0 0
Dec 2011

Eligibility
Key inclusion criteria
* Diagnosis of AML as defined by the World Health Organization (WHO) classification (Vardiman 2009)
* Primary refractory AML (defined as a failure to achieve a CR or CRi after therapy with curative intent) or AML in first relapse
* ECOG Performance status 0, 1 or 2
* Age > 18 and < 70 years
* For patients presenting with primary refractory AML, > 20% blasts on baseline bone marrow assessment
* For patients presenting with relapsed AML, > 5% blasts on baseline bone marrow assessment
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* An initial diagnosis of acute promyelocytic leukemia (as defined by French-American-British criteria (Bennett 1976))
* Secondary AML, defined as AML evolving from antecedent hematological disorder or prior exposure to leukemogenic therapy or agent
* Clinically active CNS leukemia
* Previously received a total cumulative dose of cytarabine > 6g/m2 in the last 6 months
* Previously received > 1 induction regimen (Defined as 1 or 2 cycles of a drug or a drug combination administered as remission induction therapy)

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
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
6000 - Perth
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
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
South Carolina
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch
Country [5] 0 0
Taiwan
State/province [5] 0 0
Changhua Country
Country [6] 0 0
Taiwan
State/province [6] 0 0
Taichung City
Country [7] 0 0
Taiwan
State/province [7] 0 0
Taipei City
Country [8] 0 0
Taiwan
State/province [8] 0 0
Taipei

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rob Stuart, MD
Address 0 0
Medical University of South Carolina
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01034410