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

Stopped early · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT01034410

Run by

Antisoma Research

People needed

90

Starts

2010-01-01

Expected to finish

2011-01-01

Last updated by the study team

2011-02-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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, Changhua Country, Taiwan
• China Medical University Hospital — Taichung, Taiwan
• Taipei Veterans General Hospital — Taipei, Taiwan
• Tri-Service General Hospital — Taipei, Taiwan
• National Taiwan University Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.