EUCTR2010-023125-38-FI进行中（未招募）不适用
Dose densified chemoimmunotherapy with early CNS prophylaxis in patients less than 65 years with high risk (aaIPI=2) Diffuse Large B-Cell Lymphoma. - CHIC
ordic Lymphoma Group0 个研究点目标入组 130 人开始时间: 2010年11月24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
- 130
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
- •Age = 18 - < 65 years.
- •Histologically confirmed CD20+ diffuse large B-cell lymphoma based on WHO
- •2008 Lymphoma Classification
- •Follicular lymphomas grade 3b is allowed
- •Patients in at least stage II with age adjusted IPI score of 2 or 3:
- •Stage III /IV and elevated LDH
- •Stage III/IV and WHO performance status 2 - 3
- •Stage II and elevated LDH and WHO performance status 2 – 3
- •And/or patients with
- •More than one extranodal site
- •Testicular lymphoma, stage IIE and higher
- •Paranasal sinus and orbital lymphoma with destruction of bone
- •Large cell infiltration of the bone marrow
- •Previously untreated, except steroids allowed
- •WHO performance status 0-3
- •Written informed consent
- •Patients with at least one of the following criteriae
- •o More than one extranodal site and elevated LDH
- •o Testicular lymphoma, stage IIE and higher
- •o Paranasal sinus and orbital lymphoma
- •o Large cell infiltration of the bone marrow
- •o Epidural lymphoma
- •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 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Severe cardiac disease: cardiac function grade 3-4
- •Impaired liver, renal or other organ function not caused by lymphoma, which will
- •interfere with the treatment schedule
- •Pregnancy/lactation
- •Men and women of reproductive potential not agreeing to use an acceptable method
- •of birth control during treatment and for six months after completion of treatment
- •Patients with other severe medical problems and with an expected short survival for
- •non-lymphoma reasons
- •Known HIV positivity
- •Uncontrolled infectious disease, including meningeal infection
- •Active cancer except basal cell carcinoma and cervical carcinoma in situ during the
- •last five years
- •Earlier treatment containing anthracyclins
- •Psychiatric or mental disorder which make the patient unable to give an informed
- •consent and/or adhere to the protocol
- •CNS disease as diagnosed by MRI or CSF cytology. Positive CSF flow cytometry
- •below diagnostic threshold level by cytology is allowed
- •Pleural or peritoneal fluid that cannot be drained safely
- •Conditions that may be compatible with impaired cerebrospinal fluid flow
- •Hypersensitity to the active substance or any of the other ingredients
- •Patients participating in other clinical studies, unless followed for survival
研究者
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