Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE2
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00952588
Start Date
July 1 2009
End Date
June 1 2011
Last Update
February 24 2020
Active Locations (45)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Atlanta, Georgia, United States
2
Research Site
Chicago, Illinois, United States
3
Research Site
New York, New York, United States
4
Research Site
Cleveland, Ohio, United States