A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia

February 1, 2011 updated by: Antisoma Research

An Open-label Randomized Controlled Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia

This is an open label randomized controlled phase II study of AS1411 combined with Cytarabine in the treatment of patients with primary refractory or relapsed acute myeloid leukemia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

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

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • New Zealand
      • Christchurch, New Zealand
        • Christchurch Hospital
  • Taiwan
      • Taichung City, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taipei City, Taiwan, 114
        • Tri-Service General Hospital
    • Changhua Country
      • Changhua City, Changhua Country, Taiwan, 500
        • Changhua Christian Hospial
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of AML as defined by the World Health Organization (WHO) classification (Vardiman 2009)
  • Primary refractory AML (defined as a failure to achieve a CR or CRi after therapy with curative intent) or AML in first relapse
  • ECOG Performance status 0, 1 or 2
  • Age > 18 and < 70 years
  • For patients presenting with primary refractory AML, > 20% blasts on baseline bone marrow assessment
  • For patients presenting with relapsed AML, > 5% blasts on baseline bone marrow assessment

Exclusion Criteria:

  • An initial diagnosis of acute promyelocytic leukemia (as defined by French-American-British criteria (Bennett 1976))
  • Secondary AML, defined as AML evolving from antecedent hematological disorder or prior exposure to leukemogenic therapy or agent
  • Clinically active CNS leukemia
  • Previously received a total cumulative dose of cytarabine > 6g/m2 in the last 6 months
  • Previously received > 1 induction regimen (Defined as 1 or 2 cycles of a drug or a drug combination administered as remission induction therapy)

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
cytarabine 2g/m2 bid Days 4-7
Drug: Cytarabine
Cytarabine 2g/m2 bid Days 4-7
Other Names:
  • Ara-C
Experimental: AS1411-40
AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7
Drug: Cytarabine
Cytarabine 2g/m2 bid Days 4-7
Other Names:
  • Ara-C
Drug: AS1411
AS1411 40mg/kg/day or AS1411 80mg/kg/day
Experimental: AS1411-80
AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7
Drug: Cytarabine
Cytarabine 2g/m2 bid Days 4-7
Other Names:
  • Ara-C
Drug: AS1411
AS1411 40mg/kg/day or AS1411 80mg/kg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the response rate (CR + CRi) of AS1411 at 40 and 80mg/kg/day in combination with cytarabine therapy with the response rate (CR + CRi) of cytarabine therapy alone
Time Frame: Dec 2011
Dec 2011

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare duration of remission, disease free survival and overall survival of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
Time Frame: Dec 2011
Dec 2011
To compare the time to hematological recovery of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
Time Frame: Dec 2011
Dec 2011
To compare the safety of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
Time Frame: Dec 2011
Dec 2011
To evaluate and compare a range of PD markers in patients administered AS1411 in combination with cytarabine therapy with the same PD markers in patients administered cytarabine therapy alone.
Time Frame: Dec 2011
Dec 2011
To further define the PK of AS1411
Time Frame: Dec 2011
Dec 2011

Collaborators and Investigators

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

Sponsor

Antisoma Research

Investigators

  • Principal Investigator: Rob Stuart, MD, Medical University of South Carolina

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

January 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (Estimate)

December 17, 2009

Study Record Updates

Last Update Posted (Estimate)

February 2, 2011

Last Update Submitted That Met QC Criteria

February 1, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS1411-C-203

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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