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) who are considered unsuitable to receive intensive induction chemotherapy regimens

Conditions: Acute Myeloid Leukemia
MedDRA version: 9.1Level: LLTClassification code 10000880Term: Acute myeloid leukaemia

Registration Number: EUCTR2009-010114-30-DE

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 420

Inclusion Criteria

1.Provision of written informed consent prior to any study specific procedures
2.Newly diagnosed male or female patients aged = 60 years
3.De Novo (primary) or Secondary AML
4.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 Grimwade et al 2001)
-WHO performance status >2
-Organ dysfunction arising from significant co-morbidities not directly linked to leukaemia
5.World Health Organisation (WHO) performance status 0-3 (WHO
performance status 3 is only acceptable if solely attributed to the
underlying leukaemia)
6.Serum bilirubin = 1.5 x Upper Limit of Normal (ULN) unless considered due
to leukaemic organ involvement (Gilbert’s or related syndrome allowed)
7.Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase
(ALT/SGPT) = 2.5 x ULN, unless considered due to leukaemic organ
involvement
8.Serum creatinine = 1.5 x ULN or 24-hour creatinine clearance > 50 mL/min
(measured or calculated by Cockcroft-Gault)
9.Likely ability to complete 3 cycles (12 weeks) of treatment
10.Evidence of post-menopausal status, or negative urinary or serum
pregnancy test for female pre-menopausal patients.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca staff and/or staff at the study site and/or agents for
AstraZeneca)
2.Previous randomisation of treatment in the present study
3.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 (to CTCAE Grade 1 or baseline, except
alopecia)
4.Administration of LDAC is clinically contraindicated
5.Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia
(APL)
6.Patients with blast crisis of chronic myeloid leukaemia
7.Mean QTc interval = 470ms calculated from 3 ECGs using Fridericia’s or
Bazett’s Correction
8.Any chemotherapy e.g. for prior MDS, apart from hydroxyurea or
intrathecal chemotherapy for CNS disease (see Section 6.4), or
radiotherapy within 14 days prior to starting the study (not including
palliative radiotherapy at local sites)
9.Persistent, chronic, clinically significant toxicities, from any prior anti-cancer
therapy greater than CTCAE Grade 1 (except alopecia)
10.Patients with symptomatic clinically defined central nervous system (CNS)
disease due to leukaemic infiltration (asymptomatic patients are eligible if
symptom free for > 10 days)
11.Uncontrolled intercurrent illness including, but not limited to active
infection, symptomatic congestive heart failure, cardiac arrhythmia, or
psychiatric illness/social situations which would limit compliance with
protocol requirements
12.Major surgery within 4 weeks prior to entry into the study (excluding the
placement of vascular access) that involved general anaesthesia or
respiratory assistance
13.Patients with documented cases of human immunodeficiency virus (HIV) or
hepatitis B or C
14.Female patients who are breast feeding, or patients of reproductive
potential not employing an effective method of birth control
15.History of hypersensitivity to active or inactive excipients of any study
medication (AZD1152 or LDAC)