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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 With Newly Diagnosed Acute Myeloid Leukaemia (AML)


Phase 2/Phase 3
60 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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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 SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteAlbany, New York  
Research SiteAkron, Ohio  
Research SiteBend, Oregon  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas