2024-514473-21-00招募中3 期
Optimizing MATRix as remission induction in PCNSL: De-escalated induction treatment in newly diagnosed primary CNS lymphoma – a randomized phase III trial
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 286
- 试验地点
- 47
- 主要终点
- Event-free survival (EFS, defined as time from randomization to premature end of treatment due to any reason, lymphoma progression or death, whichever occurs first).
研究概览
简要总结
Primary: To demonstrate superiority of a de-escalated induction treatment strategy followed by autologous stem cell transplantation compared to the standard MATRix protocol in terms of event free survival (EFS)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Immunocompetent patients with newly diagnosed primary diffuse large B-cell lymphoma of the central nervous system (PCNSL).
- •Male or female patients aged 18-65 years irrespective of KPS scale or 66-70 years with Karnofsky Performance Status Scale ≥ 50%.
- •Histologically or cytologically assessed diagnosis of high-grade Bcell lymphoma by local pathologist. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
- •Disease exclusively located in the CNS.
- •At least one measurable lesion.
- •Previously untreated patients (previous surgery or ongoing steroid treatment permitted).
- •Negative pregnancy test (only women of childbearing potential)
- •Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is legally not competent due to their PCNSL.
- •Ability to understand the nature of the trial and the trial related procedures and to comply with them (except the patients who are legally not competent due to their PCNSL; see inclusion criterion 8).
排除标准
- •Congenital or acquired immunodeficiency including HIV infection and previous organ transplantation.
- •Systemic lymphoma manifestation (outside the CNS).
- •Primary vitreoretinal lymphoma or primary leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord
- •History of other malignancy that could affect compliance with the protocol or interpretation of results I. Participants with a history of curatively treated basal or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix at any time prior to the study are eligible. II. Participants with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible. III. Participants receiving adjuvant endocrine therapy for nonmetastatic, hormone receptor-positive breast cancer for 2 or more years prior to enrolment are eligible. IV. Participants with any other malignancy treated with curative intent and in remission without treatment for 2 years prior to enrolment are eligible.
- •Previous Non-Hodgkin lymphoma at any time.
- •Inadequate renal function (creatinine clearance < 60 ml/min (MDRD)).
- •Inadequate bone marrow, cardiac, pulmonary or hepatic function according to investigator´s decision
- •Active hepatitis B (defined as HBsAg positive OR HBsAg negative but Anti-HBc and HBV DNA positive) or C disease.
- •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.
- •Clinically relevant third space fluid accumulation according to the investigator's discretion.
- •Hypersensitivity to study treatment or any component of the formulation.
- •Taking any medications that are likely to cause interactions with the study medication
- •Known or persistent abuse of medication, drugs or alcohol.
- •Active bacterial, viral or fungal infection at the discretion of the investigator
- •Patients without legal capacity who are unable to understand the nature, significance and consequences of the trial and without designated legal representative.
- •Previous participation in this trial.
- •Persons who are in a relationship of dependency/employment with the sponsor and/or the investigator.
- •Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Current or planned pregnancy, nursing (breastfeeding) period
- •For fertile patients: Failure to use one of the following safe methods of contraception: intra-uterine device; hormonal contraception in combination with a mechanical method of contraception
结局指标
主要结局
Event-free survival (EFS, defined as time from randomization to premature end of treatment due to any reason, lymphoma progression or death, whichever occurs first).
Event-free survival (EFS, defined as time from randomization to premature end of treatment due to any reason, lymphoma progression or death, whichever occurs first).
次要结局
- • Overall survival (OS) • Progression free survival (PFS) • Remission prior to consolidation therapy – RA II • Remission after consolidation – 30 days after ASCT (RA III) • Proportion of patients reaching consolidation • Quality of life (QoL): EORTC QLQ-C30, EORTC QLQ-BN20; measured during screening period, at EOT (30 days after ASCT) and thereafter every 12 months during follow-up.
研究者
Prof. Dr. Gerald Illerhaus
Scientific
Klinikum Der Landeshauptstadt Stuttgart gKAöR
研究点 (47)
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