ACTRN12617000084381进行中（未招募）2 期
BLAM- A phase IIb study of Blinatumomab + Cytarabine (AraC) and Methotrexate in adult B-precursor Acute Lymphoblastic Leukaemia
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 30 人开始时间: 2017年1月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.Age 40 to 65 (inclusive)
- •2.Newly diagnosed B-precursor acute lymphoblastic leukaemia without Ph positive disease
- •3.CD19 positive diseases
- •4.Provision of informed consent for this study
- •5.Patient has a life-expectancy from non-leukaemia related causes ofgreater than 3 months
- •6.ECOG performance status of 0 to 2 inclusive
- •7.Absence of serious cardiac, pulmonary, hepatic or renal disease. A serum creatinine of less than 1.5 times the institutional upper limit of normal (ULN) and serum bilirubin less than 2.5 times ULN is required
- •8.Normal left ventricular ejection fraction, as per local institutional standards
- •9.No contraindication for use of study drugs
排除标准
- •1.A history of major medication non-compliance
- •2.Evidence of known active central nervous system (CNS) leukaemia
- •3.History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, or psychosis, with the exception of history of CNS leukaemia that is controlled with intrathecal therapy
- •4.Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- •5.Pregnant or lactating
- •6.Women of child-bearing potential who are not willing to use 2 highly effective methods of contraception while receiving study therapy and for 3 months after completion
- •7.Men who are not willing to use 2 highly effective methods of contraception while receiving study therapy and for 3 months after completion
- •8.Men who have a pregnant partner and are not willing to use a condom while performing sexual activity or for 3 months after completion of study therapy
- •9.Subjects with a known sensitivity to immunoglobulins or other components of the investigational product
- •10.Previous diagnosis of cancer within 5 years of current diagnosis except successfully treated Basal Cell Carcinoma, Squamous Cell Carcinoma or carcinoma in situ of the cervix
- •11.HIV positive
- •12.Significant active liver disease or active Hepatitis C Virus (HCV; RNA polymerase chain reaction [PCR]-positive) or active Hepatitis B Virus (HBV; DNA PCR-positive) infection. Only patients who are HBV surface antigen (HBVsAg) and/or HBV core antibody (HBVcAb) positive are required to undergo HBV DNA PCR testing. Subjects with PCR-negative HBV or who are HBV core antibody positive are permitted in the study but must be on HBV prophylaxis.
- •13.Presence of New York Heart Association stage 2 or higher cardiac symptoms not related to the disease under study
- •14.Significant concomitant illnesses which would in the investigator’s opinion not make the patient a good candidate for the trial
- •15.Any other form of known condition or behaviour that deems the patient a poor candidate
- •16.Subjects who have been vaccinated with live virus vaccines less than 2 weeks prior to registration.
研究者
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