EUCTR2017-000766-30-NL进行中（未招募）1 期
Blinatumomab added to prephase and consolidation therapy in precursor B-acute lymphoblastic leukemia in adults.A phase II trial.
HOVON Foundation0 个研究点目标入组 71 人开始时间: 2017年12月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 71
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
- •-Primary CD19 positive precursor B-ALL (excluding mature B-cell ALL and B-lymphoblastic lymphoma, but including Philadelphia positive/BCR-ABL positive ALL) and CD19 positive mixed phenotype acute lymphoblastic leukemia (MPAL);
- •-Patients aged 18 to 70 years inclusive;
- •-WHO performance status 0-2;
- •-Negative pregnancy test at inclusion, if applicable;
- •-Written informed consent;
- •-Patient is capable of giving 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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •-Mature B-cell leukemia/lymphoma, B-lymphoblastic lymphoma, isolated extramedullary disease;
- •-CML in blast crisis;
- •-Acute undifferentiated leukemia;
- •-Previous treatment with chemotherapy for precursor B-ALL (maximum 5 days of steroid treatment is allowed)
- •-Persistent liver enzyme disorders (ASAT/ALAT) >5xULN despite steroid pre-treatment (see also 8.1.3.)
- •-Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
- •-Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
- •-Severe neurological or psychiatric disease;
- •-Active, uncontrolled infection;
- •-Clinically overt central nervous system disease;
- •-Patients with a currently active second malignancy. Patients are not considered to have a currently active malignancy if they have completed therapy and are considered by their physician to be at < 30% risk of relapse within one year. However, patients with the following history/concurrent conditions are allowed:
- •o Basal or squamous cell carcinoma of the skin
- •o Carcinoma in situ of the cervix
- •o Carcinoma in situ of the breast
- •o Incidental histologic finding of prostate carcinoma
- •-Patient known to be HIV-positive;
- •-Pregnant or breast-feeding female patients;
- •-Unwilling or not capable to use effective means of birth control (all men, all premenopausal women under the age of 50 need contraception for two years after the last period, and women older than 50 years for at least one year);
- •-Current participation in another clinical trial;
- •-Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
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