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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
This is 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.
Trial website
https://clinicaltrials.gov/show/NCT01034410
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01034410