Leukemia, Myeloid Clinical Trial
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
NCT number | NCT00512083 |
Other study ID # | AS1411-C-201 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | August 6, 2007 |
Last updated | September 24, 2009 |
Start date | July 2007 |
Verified date | September 2009 |
Source | Antisoma Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 70 |
Est. completion date | |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
New Zealand | Christchurch Hospital | Christchurch | |
United States | Univeristy of Colorado Health Cancer Center | Aurora | Colorado |
United States | St. Francis Hospital and Health Center | Beech Grove | Indiana |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Duke University Medical Center | Durham | North Carolina |
United States | UCLA Medical Center | Los Angeles | California |
United States | University of Louisville, James Graham Brown Cancer Center | Louisville | Kentucky |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Cancer Therapy and Research Center - Institute for Drug development | San Antonio | Texas |
United States | Washington University | St Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Antisoma Research |
United States, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group | No |
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