Trial record 4 of 4 for:    as1411

Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00512083
Recruitment Status : Completed
First Posted : August 7, 2007
Last Update Posted : September 25, 2009
Information provided by:
Antisoma Research

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).

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid Drug: AS1411 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2007
Actual Primary Completion Date : April 2009

Intervention Details:
  • Drug: AS1411
    AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.

Primary Outcome Measures :
  1. The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00512083

United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Colorado
Univeristy of Colorado Health Cancer Center
Aurora, Colorado, United States, 80010
United States, Indiana
St. Francis Hospital and Health Center
Beech Grove, Indiana, United States, 46107
United States, Kentucky
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Missouri
Washington University
St Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Cancer Therapy and Research Center - Institute for Drug development
San Antonio, Texas, United States, 78229
New Zealand
Christchurch Hospital
Christchurch, New Zealand
Sponsors and Collaborators
Antisoma Research Identifier: NCT00512083     History of Changes
Other Study ID Numbers: AS1411-C-201
First Posted: August 7, 2007    Key Record Dates
Last Update Posted: September 25, 2009
Last Verified: September 2009

Keywords provided by Antisoma Research:
Leukemia, Myeloid + Acute Disease

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs