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

This study has been completed.
Sponsor:
Information provided by:
Antisoma Research
ClinicalTrials.gov Identifier:
NCT00512083
First received: August 6, 2007
Last updated: September 24, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Leukemia, Myeloid
Drug: AS1411
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Antisoma Research:

Primary Outcome Measures:
  • The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2007
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AS1411
    AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512083

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00512083     History of Changes
Other Study ID Numbers: AS1411-C-201
Study First Received: August 6, 2007
Last Updated: September 24, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 20, 2014