Study to Investigate the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC)in Acute Myeloid Leukaemia (AML) Patients (SPARK-AML1)

AstraZeneca

Status and phase

Completed

Phase 3

Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

Drug: AZD1152

Drug: LDAC

Study type

Interventional

Funder types

Industry

Identifiers

NCT00952588

D1531C00009

Details and patient eligibility

About

The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in AML patients.

Enrollment

74 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of written informed consent
Newly diagnosed male or female patients aged 60 and over
De Novo or Secondary AML
Not eligible for intensive induction with anthracycline-based combination chemotherapy as a result of at least one of the following:Age ≥75 years; Adverse cytogenetics, e.g., as defined by the MRC Prognostic Groupings; WHO performance status >2; Organ dysfunction arising from significant co-morbidities not directly linked to leukaemia

Exclusion criteria

Participation in another clinical study in which an investigational product was received within 14 days before the first dose in this study, or at any time if the patient has not recovered from side-effects associated with that investigational product
Administration of LDAC is clinically contraindicated
Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL)
Patients with blast crisis of chronic myeloid leukaemia