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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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Acute Myeloid Leukemia

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

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

Outcome 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

Outcome Time Frame:

Dec 2011

Safety Issue:

No

Principal Investigator

Rob Stuart, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MUSC

Authority:

United States: Food and Drug Administration

Study ID:

AS1411-C-203

NCT ID:

NCT01034410

Start Date:

January 2010

Completion Date:

January 2011

Related Keywords:

  • Acute Myeloid Leukemia
  • AS1411
  • AML
  • relapsed
  • refractory
  • aptamer
  • nucleolin
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Medical University of South Carolina Charleston, South Carolina  29425-0721
Weill Medical College of Cornell University New York, New York  10021
UCLA Los Angeles, California  90095