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 With Newly Diagnosed Acute Myeloid Leukaemia (AML)
60 Years
N/A
Both
Acute Myeloid Leukemia
Trial Information
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 With Newly Diagnosed Acute Myeloid Leukaemia (AML)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Complete Response Rate: Defined as the proportion of patients achieving a Complete Remission or Complete Remission with incomplete recovery of neutrophils and platelets
Outcome Time Frame:
Day 1 Predose and day 28 of each cycle, treatment stop and follow-up visits.
Safety Issue:
No
Principal Investigator
Paul Stockman
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D1531C00009
NCT ID:
NCT00952588
Start Date:
July 2009
Completion Date:
June 2015
Related Keywords:
- Acute Myeloid Leukemia
- Acute Myeloid Leukaemia, AML
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Research Site | Albany, Georgia |
| Research Site | Arlington Heights, Illinois |
| Research Site | Albany, New York |
| Research Site | Akron, Ohio |
| Research Site | Bend, Oregon |
| Research Site | Charleston, South Carolina |
| Research Site | Chattanooga, Tennessee |
| Research Site | Abilene, Texas |
