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A Randomised, Open-label, Multi-centre, 2-stage, Parallel Group Study 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 Patients Aged 60 or more With Newly Diagnosed Acute Myeloid Leukaemia (AML)

A Randomised, Open-label, Multi-centre, 2-stage, Parallel Group Study 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 Patients Aged 60 or more With Newly Diagnosed Acute Myeloid Leukaemia (AML)

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220925
Enrollment
Unknown
Registered
2009-11-30
Start date
2009-11-30
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Acute Myeloid Leukemia

Interventions

investigational material(s) Generic name etc : AZD1152, AZD1152 + LDAC INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investiga

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Not eligible for intensive induction with anthracycline-based combination chemotherapy as a result of at least one of the followings -Age at 75 years or more -Adverse cytogenetics, eg as defined by the MRC Prognostic Groupings -WHO performance status 3 or more -Organ dysfunction arising from significant co-morbidities not directly linked to leukaemia

Exclusion criteria

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026