MedPath

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

Phase 2
Terminated
Conditions
Acute Myeloid Leukemia
Interventions
Registration Number
NCT01034410
Lead Sponsor
Antisoma Research
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
90
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
AS1411-40AS1411AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7
AS1411-80AS1411AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7
ControlCytarabinecytarabine 2g/m2 bid Days 4-7
AS1411-40CytarabineAS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7
AS1411-80CytarabineAS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7
Primary Outcome Measures
NameTimeMethod
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 aloneDec 2011
Secondary Outcome Measures
NameTimeMethod
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.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.Dec 2011
To compare the safety of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.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.Dec 2011
To further define the PK of AS1411Dec 2011

Trial Locations

Locations (14)

UCLA

🇺🇸

Los Angeles, California, United States

Weill Medical College of Cornell University

🇺🇸

New York, New York, United States

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

Royal North Shore Hospital

🇦🇺

St Leonards, New South Wales, Australia

Westmead Hospital

🇦🇺

Westmead, New South Wales, Australia

Royal Adelaide Hospital

🇦🇺

Adelaide, South Australia, Australia

The Alfred Hospital

🇦🇺

Melbourne, Victoria, Australia

Royal Perth Hospital

🇦🇺

Perth, Western Australia, Australia

Christchurch Hospital

🇳🇿

Christchurch, New Zealand

Changhua Christian Hospial

🇨🇳

Changhua City, Changhua Country, Taiwan

Scroll for more (4 remaining)
UCLA
🇺🇸Los Angeles, California, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.