EUCTR2012-000620-17-DE进行中（未招募）1 期
High-dose chemotherapy and autologous stem cell transplant or consolidating conventional chemotherapy in primary CNS lymphoma - randomized phase III trial - MATRix / IELSG43
andeshauptstadt Stuttgart, represented by the Executive Medical Director Klinikum Stuttgart0 个研究点目标入组 330 人开始时间: 2014年2月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 330
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
- •1.Immunocompetent patients with newly-diagnosed primary central nervous system B-cell lymphoma
- •2.Age 18-65 years irrespective of ECOG or 66-70 years (with ECOG Performance Status =2)
- •3.Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy
- •4.Disease exclusively located in the CNS
- •5.At least one measurable lesion
- •6.Previously untreated patients (previous or ongoing steroid treatment admitted)
- •7.Sexually active patients of childbearing potential who agree to take adequate contraceptive measures during study participation
- •8.Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is temporarily legally not competent due to his or her disease
- •ADDITIONAL RANDOMIZATION CRITERIA
- •1.Sufficient stem cell harvest (= 5 x 106 CD34+ cells/kg of body weight)
- •2.Complete remission, unconfirmed complete remission or partial remission
- •3.Central pathology results confirming local results
- •4. Exclusion criterion no. 6 not applicable for re-check for randomization
- •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 265
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1.Congenital or acquired immunodeficiency
- •2.Systemic lymphoma manifestation (outside the CNS)
- •3.Isolated ocular lymphoma without manifestation in the brain parenchyma or spinal cord
- •4.Previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other kinds of cancer without evidence of disease for at least 5 years
- •5.Previous Non-Hodgkin lymphoma at any time
- •6.Only applicable for patient inclusion (registration) not applicable for re-check for randomization: Inadequate bone marrow (platelet count decreased =CTC grade 1, anemia =CTC grade 1, neutrophil count decreased =CTC grade 1), renal (creatinine clearance <60 ml/min), cardiac (ejection fraction decreased =CTC grade 2), or hepatic function (blood bilirubin increased =CTC grade 2, alanine aminotransferase increased =CTC grade 2, aspartate aminotransferase increased =CTC grade 2 or gamma-GT increased =CTC grade 2)
- •7.HBsAg, anti-HBc and HCV positivity
- •8.HIV infection, previous organ transplantation or other clinical evident form of immunodeficiency
- •9.Concurrent treatment with other experimental drugs or participation in a clinical trial within the last thirty days before the start of this study
- •10.Symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)
- •11.Severe non-compensated pulmonary disease (IVC <55%, DLCO <40%)
- •12.Third space fluid accumulation >500 ml
- •13.Hypersensitivity to study treatment or any component of the formulation
- •14.Taking any medications likely to cause interactions with the study medication
- •15.Known or persistent abuse of medication, drugs or alcohol
- •16.Patient without legal capacity and who is unable to understand the nature, significance and consequences of the study and without designated legal representative
- •17.Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator
- •18.Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •19.Concurrent (or planned) pregnancy or lactation
- •20.Fertile patients refusing to use safe contraceptive methods during the study (for details see clinical trial protocol section 4.3)
研究者
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