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

Phase 2

Terminated

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
AS1411-40	AS1411	AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7
AS1411-80	AS1411	AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7
Control	Cytarabine	cytarabine 2g/m2 bid Days 4-7
AS1411-40	Cytarabine	AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7
AS1411-80	Cytarabine	AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7

Primary Outcome Measures

Name	Time	Method
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	Dec 2011

Secondary Outcome Measures

Name	Time	Method
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 AS1411	Dec 2011

Locations (14): National Taiwan University Hospital
🇨🇳
Taipei, Taiwan
Westmead Hospital
🇦🇺
Westmead, New South Wales, Australia
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
China Medical University Hospital
🇨🇳
Taichung City, Taiwan
Royal North Shore Hospital
🇦🇺
St Leonards, New South Wales, Australia
Taipei Veterans General Hospital
🇨🇳
Taipei, Taiwan
The Alfred Hospital
🇦🇺
Melbourne, Victoria, Australia
Weill Medical College of Cornell University
🇺🇸
New York, New York, United States
UCLA
🇺🇸
Los Angeles, California, United States
Royal Adelaide Hospital
🇦🇺
Adelaide, South Australia, Australia
Changhua Christian Hospial
🇨🇳
Changhua City, Changhua Country, Taiwan
Tri-Service General Hospital
🇨🇳
Taipei City, Taiwan
Royal Perth Hospital
🇦🇺
Perth, Western Australia, Australia
Christchurch Hospital
🇳🇿
Christchurch, New Zealand