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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01034410

Enrollment

Registered

2009-12-17

Start date

2010-01-31

Completion date

2011-01-31

Last updated

2011-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

AS1411, AML, relapsed, refractory, aptamer, nucleolin

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.

Interventions

DRUGAS1411

AS1411 40mg/kg/day or AS1411 80mg/kg/day

DRUGCytarabine

Cytarabine 2g/m2 bid Days 4-7

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Australia, New Zealand, Taiwan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026