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

This study has been terminated.
Sponsor:
Information provided by:
Antisoma Research
ClinicalTrials.gov Identifier:
NCT01034410
First received: December 16, 2009
Last updated: February 1, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: AS1411
Drug: Cytarabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Antisoma Research:

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 [ Time Frame: Dec 2011 ] [ Designated as safety issue: No ]

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. [ Time Frame: Dec 2011 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • To further define the PK of AS1411 [ Time Frame: Dec 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
cytarabine 2g/m2 bid Days 4-7
Drug: Cytarabine
Cytarabine 2g/m2 bid Days 4-7
Other Name: Ara-C
Experimental: AS1411-40
AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7
Drug: AS1411
AS1411 40mg/kg/day or AS1411 80mg/kg/day
Drug: Cytarabine
Cytarabine 2g/m2 bid Days 4-7
Other Name: Ara-C
Experimental: AS1411-80
AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7
Drug: AS1411
AS1411 40mg/kg/day or AS1411 80mg/kg/day
Drug: Cytarabine
Cytarabine 2g/m2 bid Days 4-7
Other Name: Ara-C

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034410

Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Australia, New South Wales
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
New Zealand
Christchurch Hospital
Christchurch, New Zealand
Taiwan
Changhua Christian Hospial
Changhua City, Changhua Country, Taiwan, 500
China Medical University Hospital
Taichung City, Taiwan, 40447
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Tri-Service General Hospital
Taipei City, Taiwan, 114
Sponsors and Collaborators
Antisoma Research
Investigators
Principal Investigator: Rob Stuart, MD MUSC
  More Information

No publications provided

Responsible Party: Fredrik Erlandsson, MD, Antisoma
ClinicalTrials.gov Identifier: NCT01034410     History of Changes
Other Study ID Numbers: AS1411-C-203
Study First Received: December 16, 2009
Last Updated: February 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Antisoma Research:
AS1411
AML
relapsed
refractory
aptamer
nucleolin

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 April 17, 2014