EUCTR2018-002115-96-IT招募中1 期
Optimizing MATRix as remission induction in PCNSL: De-escalated induction treatment in newly diagnosed primary CNS lymphoma – a randomized phase III trial - OptiMATe
CITY OF STUTTGART, REPRESENTED BY KLINIKUM STUTTGART0 个研究点目标入组 326 人开始时间: 2023年1月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 326
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
- 性别
- All
入选标准
- •1. Immunocompetent patients with newly diagnosed primary diffuse large B-cell lymphoma (DLBCL) of the central nervous system.
- •2. Male or female patients aged 18-65 years irrespective of ECOG or 66-70 years with ECOG Performance Status 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 surgery or ongoing steroid treatment admitted).
- •7. Negative pregnancy test.
- •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.
- •9. Ability to understand the nature of the trial and the trial related procedures and to comply with them.
- •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 249
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 77
排除标准
- •1. Congenital or acquired immunodeficiency including HIV infection and previous organ transplantation.
- •2. Systemic lymphoma manifestation (outside the CNS).
- •3. Primary vitreoretinal lymphoma or primary leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord
- •4. Previous or concurrent malignancies with the exception of surgically cured carcinoma in situ or other kinds of cancer without evidence of disease for at least 5 years.
- •5. Previous Non-Hodgkin lymphoma at any time.
- •6. Inadequate renal function (clearance < 60 ml/min).
- •7. Inadequate bone marrow, cardiac, pulmonary or hepatic function according to investigator´s decision
- •8. Active hepatitis B or C disease.
- •9. Concurrent treatment with other experimental drugs or participation in an interventional clinical trial with study medication being administered within the last 30 days before the start of this study.
- •10. Clinically relevant third space fluid accumulation according to the investigator's discretion.
- •11. Hypersensitivity to study treatment or any component of the formulation.
- •12. Taking any medications that are likely to cause interactions with the study medication
- •13. Known or persistent abuse of medication, drugs or alcohol.
- •14. Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic
- •15. Patients without legal capacity who are unable to understand the nature, significance and consequences of the trial and without designated legal representative.
- •16. Previous participation in this trial.
- •17. Persons who are in a relationship of dependency/ employment with the sponsor and/ or the investigator.
- •18. Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •19. Current or planned pregnancy, nursing period
- •20. For fertile patients: Failure to use one of the following safe methods of contraception: intra-uterine device or hormonal contraception in combination with a mechanical method of contraception.
研究者
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