ISRCTN18332222未知2 期
A phase II multicentre study to assess the tolerability and efficacy of the addition of bevacizumab to standard induction therapy in Acute Myeloid Leukaemia and high risk myelodysplastic syndrome above 60 years
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands)0 个研究点目标入组 200 人开始时间: 2007年3月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients greater than 60 years
- •2. Patients eligible for standard chemotherapy
- •3. Patients with a confirmed diagnosis of Acute Myeloid Leukaemia (AML) French-American-British (FAB) classification M0 - M2 or M4 - M7 or with Refractory Anaemia with Excess of Blasts (RAEB) or Refractory Anaemia with Excess of Blasts in Transformation (RAEB-T) with an International Prognostic Scoring System (IPSS) score greater than or equal to 1.5
- •4. Subjects with secondary AML progressing from antecedent (at least four months duration) myelodysplasia are also eligible.
- •5. Serum Glutamic Oxaloacetic Transaminase (SGOT) (Aspartate aminotransferase [AST]) and Serum Glutamic Pyruvic Transaminase (SGPT) (Alanine Aminotransferase [ALT]) less than or equal to 1.5 x the Upper Limit of the Normal range (ULN) at the laboratory where the analyses were performed
- •6. Total serum bilirubin level less than or equal to 1.5 x the ULN at the laboratory where the analysis was performed
- •7. Serum creatinine concentration less than or equal to 1.5 x the ULN at the laboratory where the analysis was performed
- •8. Proteinuria at baseline: urine dipstick of proteinuria less than 2+. Patients discovered to have greater than or equal to 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate less than or equal to 1 g of protein/24 hr
- •9. World Health Organisation (WHO) performance status less than or equal to two
- •10. Written informed consent
排除标准
- •1. Patients previously treated for AML (any anti-leukaemic therapy including investigational agents)
- •2. Past or current history (within the last two years prior to randomisation) of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin or in-situ carcinoma of the cervix
- •3. Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents (less than or equal to six months prior to randomisation), myocardial infarction (less than or equal to six months prior to randomisation), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, reduced left ventricular ejection fraction of less than 50% as evaluated by echocardiogram or Multiple Gated Acquisition (MUGA) scan
- •4. Uncontrolled hypertension
- •5. Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance
- •6. Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study
- •7. Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent
- •8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study
- •9. Serious, non-healing wound, ulcer, or bone fracture
- •10. Patients with bleeding diathesis or coagulopathy (unless related to AML)
- •11. Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanised antibodies or to any excipients of bevacizumab formulation; or to any other study drugs
研究者
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