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

September 24, 2009 updated by: Antisoma Research

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Christchurch, New Zealand
        • Christchurch Hospital
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80010
        • Univeristy of Colorado Health Cancer Center
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • St. Francis Hospital and Health Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville, James Graham Brown Cancer Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy and Research Center - Institute for Drug development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

August 6, 2007

First Submitted That Met QC Criteria

August 6, 2007

First Posted (ESTIMATE)

August 7, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 25, 2009

Last Update Submitted That Met QC Criteria

September 24, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • AS1411-C-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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