A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
NCT ID: NCT01034410
Last Updated: 2011-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
90 participants
INTERVENTIONAL
2010-01-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Control
cytarabine 2g/m2 bid Days 4-7
Cytarabine
Cytarabine 2g/m2 bid Days 4-7
AS1411-40
AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7
AS1411
AS1411 40mg/kg/day or AS1411 80mg/kg/day
Cytarabine
Cytarabine 2g/m2 bid Days 4-7
AS1411-80
AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7
AS1411
AS1411 40mg/kg/day or AS1411 80mg/kg/day
Cytarabine
Cytarabine 2g/m2 bid Days 4-7
Interventions
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AS1411
AS1411 40mg/kg/day or AS1411 80mg/kg/day
Cytarabine
Cytarabine 2g/m2 bid Days 4-7
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
No
Sponsors
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Antisoma Research
INDUSTRY
Responsible Party
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Antisoma
Principal Investigators
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Rob Stuart, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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UCLA
Los Angeles, California, United States
Weill Medical College of Cornell University
New York, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Christchurch Hospital
Christchurch, , New Zealand
Changhua Christian Hospial
Changhua, Changhua Country, Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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AS1411-C-203
Identifier Type: -
Identifier Source: org_study_id
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