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

Antisoma Research

Status and phase: Terminated; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Cytarabine; Drug: AS1411

Study type: Interventional

Funder types: Industry

Identifiers

NCT01034410

AS1411-C-203

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Control

Active Comparator group

Description:

cytarabine 2g/m2 bid Days 4-7

Treatment:

Drug: Cytarabine

AS1411-40

Experimental group

Description:

AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7

Treatment:

Drug: AS1411

Drug: Cytarabine

AS1411-80

Experimental group

Description:

AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7

Treatment:

Drug: AS1411

Drug: Cytarabine