A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
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
1 other identifier
interventional
90
4 countries
14
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2010
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2009
CompletedFirst Posted
Study publicly available on registry
December 17, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFebruary 2, 2011
February 1, 2011
1 year
December 16, 2009
February 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Dec 2011
Secondary Outcomes (5)
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.
Dec 2011
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.
Dec 2011
To compare the safety of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
Dec 2011
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.
Dec 2011
To further define the PK of AS1411
Dec 2011
Study Arms (3)
Control
ACTIVE COMPARATORcytarabine 2g/m2 bid Days 4-7
AS1411-40
EXPERIMENTALAS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7
AS1411-80
EXPERIMENTALAS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
UCLA
Los Angeles, California, 90095, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Christchurch Hospital
Christchurch, New Zealand
Changhua Christian Hospial
Changhua, Changhua Country, 500, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rob Stuart, MD
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 16, 2009
First Posted
December 17, 2009
Study Start
January 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
February 2, 2011
Record last verified: 2011-02