Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia
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
1 other identifier
interventional
70
2 countries
10
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 6, 2007
CompletedFirst Posted
Study publicly available on registry
August 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedSeptember 25, 2009
September 1, 2009
1.8 years
August 6, 2007
September 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group
Interventions
AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
UCLA Medical Center
Los Angeles, California, 90095, United States
Univeristy of Colorado Health Cancer Center
Aurora, Colorado, 80010, United States
St. Francis Hospital and Health Center
Beech Grove, Indiana, 46107, United States
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Washington University
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Cancer Therapy and Research Center - Institute for Drug development
San Antonio, Texas, 78229, United States
Christchurch Hospital
Christchurch, New Zealand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 6, 2007
First Posted
August 7, 2007
Study Start
July 1, 2007
Primary Completion
April 1, 2009
Last Updated
September 25, 2009
Record last verified: 2009-09