Clinical trial NCT01034410: A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: AS1411
AML
relapsed
refractory
aptamer
nucleolin
Lead sponsor: Antisoma Research
Sponsor class: INDUSTRY
First posted: 2009-12-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: Dec 2011
Secondary outcomes:
measure: 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.
timeFrame: Dec 2011
measure: 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.
timeFrame: Dec 2011
measure: To compare the safety of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.
timeFrame: Dec 2011
measure: 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.
timeFrame: Dec 2011
measure: To further define the PK of AS1411
timeFrame: Dec 2011
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospial
state: Changhua Country
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Medical University of South Carolina
name: Rob Stuart, MD
role: PRINCIPAL_INVESTIGATOR
References: