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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01034410
• Other study ID #: AS1411-C-203
• Status: Terminated
• Phase: Phase 2
• First received: December 16, 2009
• Last updated: February 1, 2011
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: February 2011
• Source: Antisoma Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

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)

Study Design

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• AS1411
AS1411 40mg/kg/day or AS1411 80mg/kg/day
• Cytarabine
Cytarabine 2g/m2 bid Days 4-7

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
New Zealand	Christchurch Hospital	Christchurch
Taiwan	Changhua Christian Hospial	Changhua City	Changhua Country
Taiwan	China Medical University Hospital	Taichung City
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei City
United States	Medical University of South Carolina	Charleston	South Carolina
United States	UCLA	Los Angeles	California
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Antisoma Research

Countries where clinical trial is conducted

United States,  Australia,  New Zealand,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	To compare the safety of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.		Dec 2011	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	To further define the PK of AS1411		Dec 2011	No