EUCTR2006-001777-19-NL进行中（未招募）不适用
A Phase II multicenter study to assess the tolerability and efficacy of the addition of Bevacizumab to standard induction therapy in AML and high risk MDS above 60 years. - HOVON 81 AM
HOVON foundation0 个研究点目标入组 200 人开始时间: 2006年8月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients > 60 years.
- •-Patients eligible for standard chemotherapy.
- •-Patients with a confirmed diagnosis of
- •*AML FAB M0-M2 or M4-M7 (see appendix A) or
- •*with refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-T) with an IPSS score = 1.5 (see Appendix B)
- •Subjects with secondary AML progressing from antecedent (at least 4 months duration) myelodysplasia are also eligible.
- •-SGOT (AST) and SGPT (ALT) = 1.5 x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed.
- •--Total serum bilirubin level = 1.5 x the ULN at the laboratory where the analysis was performed.
- •-Serum creatinine concentration = 1.5 x the ULN at the laboratory where the analysis was performed.
- •-Proteinuria at baseline: Urine dipstick of proteinuria <2+. Patients discovered to have = 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate = 1 g of protein/24 hr.
- •-WHO performance status = 2 (see Appendix G)
- •-Written informed consent.
- •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
- •-Patients previously treated for AML (any antileukemic therapy including investigational agents)
- •-Past or current history (within the last 2 years prior to randomization) of malignancies except for the indication under this study and curatively treated:
- •*Basal and squamous cell carcinoma of the skin
- •*in situ carcinoma of the cervix
- •-Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents (=6 months prior to randomization), myocardial infarction (= 6 months prior to randomization), 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 < 50% as evaluated by echocardiogram or MUGA scan.
- •-Uncontrolled hypertension
- •-Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance
- •-Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study.
- •-Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
- •-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
- •-Serious, non-healing wound, ulcer, or bone fracture
- •-Patients with bleeding diathesis or coagulopathy (unless related to AML)
- •-Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies or to any excipients of bevacizumab formulation; or to any other study drugs.
研究者
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