NL-OMON50553招募中2 期
Blinatumomab added to prephase and consolidation therapy in precursor B-acute lymphoblastic leukemia in adults. A phase II trial. - HOVON 146 A
HOVO0 个研究点目标入组 65 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 65
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
- 年龄范围
- 18 至 99（—）
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.
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;
- •- Severe cardiovascular disease (arrhythmias requiring chronic treatment,
- •congestive heart failure or symptomatic ischemic heart disease);
- •- Severe pulmonary dysfunction (CTCAE grade III-IV);
- •- 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
- •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
研究者
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