Back to resultsPhase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia
Primary Purpose
Leukemia, Myeloid
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AS1411
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid focused on measuring Leukemia, Myeloid + Acute Disease
Eligibility Criteria
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
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
Sites / Locations
- UCLA Medical Center
- Univeristy of Colorado Health Cancer Center
- St. Francis Hospital and Health Center
- University of Louisville, James Graham Brown Cancer Center
- Washington University
- University of Nebraska Medical Center
- Duke University Medical Center
- Medical University of South Carolina
- Cancer Therapy and Research Center - Institute for Drug development
- Christchurch Hospital
Outcomes
Primary Outcome Measures
The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00512083
Brief Title
Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Antisoma Research
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid
Keywords
Leukemia, Myeloid + Acute Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AS1411
Intervention Description
AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.
Primary Outcome Measure Information:
Title
The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Univeristy of Colorado Health Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
St. Francis Hospital and Health Center
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
University of Louisville, James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Washington University
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Cancer Therapy and Research Center - Institute for Drug development
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia
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