EUCTR2009-010114-30-DE进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •4.Administration of LDAC is clinically contraindicated
- •5.Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia
- •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)
研究者
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