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

Primary Purpose

Acute Myeloid Leukemia

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AS1411
Cytarabine
Sponsored by
Antisoma Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AS1411, AML, relapsed, refractory, aptamer, nucleolin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UCLA
  • Weill Medical College of Cornell University
  • Medical University of South Carolina
  • Royal North Shore Hospital
  • Westmead Hospital
  • Royal Adelaide Hospital
  • The Alfred Hospital
  • Royal Perth Hospital
  • Christchurch Hospital
  • Changhua Christian Hospial
  • China Medical University Hospital
  • Tri-Service General Hospital
  • Taipei Veterans General Hospital
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control

AS1411-40

AS1411-80

Arm Description

cytarabine 2g/m2 bid Days 4-7

AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7

AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
To compare the safety of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
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.
To further define the PK of AS1411

Full Information

First Posted
December 16, 2009
Last Updated
February 1, 2011
Sponsor
Antisoma Research
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1. Study Identification

Unique Protocol Identification Number
NCT01034410
Brief Title
A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Terminated
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Antisoma Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AS1411, AML, relapsed, refractory, aptamer, nucleolin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
cytarabine 2g/m2 bid Days 4-7
Arm Title
AS1411-40
Arm Type
Experimental
Arm Description
AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7
Arm Title
AS1411-80
Arm Type
Experimental
Arm Description
AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7
Intervention Type
Drug
Intervention Name(s)
AS1411
Intervention Description
AS1411 40mg/kg/day or AS1411 80mg/kg/day
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Ara-C
Intervention Description
Cytarabine 2g/m2 bid Days 4-7
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
To further define the PK of AS1411
Time Frame
Dec 2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob Stuart, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Changhua Christian Hospial
City
Changhua City
State/Province
Changhua Country
ZIP/Postal Code
500
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei City
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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