EUCTR2009-010114-30-ES进行中（未招募）不适用
Ensayo aleatorizado, abierto, multicéntrico, en 2 fases, con grupos paralelos, para evaluar la eficacia, seguridad y tolerabilidad de AZD1152 sólo y en combinación con dosis bajas de arabinósido de citosina (DBAraC), comparado con DBAraC sólo, en pacientes de edad mayor o igual a 60 años con leucemia mieloide aguda (LMA) de nuevo diagnostico, que se han considerado no candidatos a quimioterapia intensiva de inducción.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 greater than or equal to 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 greater than or equal to 60 years
- •3.De Novo (primary) or Secondary AML
- •4.Not eligible for intensive induction chemotherapy because of medical, social or psychological reasons
- •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 lower than or equal to 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) lower than or equal to 2.5 x ULN, unless considered due to leukaemic organ involvement
- •8.Serum creatinine lower than or equal to 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 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 greater than or equal to 470ms calculated from 3 ECGs using Fridericia's or Bazett's Correction
- •8.Any chemotherapy e.g. for prior MDS, 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 (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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