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

• Status: Terminated
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Antisoma Research
• Treatments: Cytarabine

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)