2024-512320-11-00招募中3 期
Age-adjusted high-dose chemotherapy followed by autologous stem cell transplantation or conventional chemotherapy with R-MP as first-line treatment in elderly primary CNS lymphoma patients – a randomized phase III trial - PRIMA-CNS
Medical Center - University Of Freiburg43 个研究点 分布在 2 个国家目标入组 260 人开始时间: 2024年8月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 43
- 主要终点
- Progression free survival
研究概览
简要总结
Primary: To demonstrate that intensified chemotherapy followed by consolidating high-dose chemotherapy and autologous stem-cell transplantation (HCT-ASCT) is superior to conventional chemotherapy with R-MP followed by maintenance in elderly patients with newly diagnosed PCNSL in terms of progression free survival (PFS). Secondary: To compare quality of life, remission after induction treatment, remission after maintenance treatment (arm A) / consolidation treatment (arm B), event free survival, overall survival and treatment related morbidities (neurotoxicity and adverse events) between both treatment arms.
研究设计
- 分配方式
- Randomized
- 主要目的
- Age-adjusted high-dose chemotherapy followed by autologous stem cell transplantation or conventional
- 盲法
- None
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Immunocompetent patients with newly-diagnosed primary DLBCL of the central nervous system.
- •Age > 70 years or age 65-70 years if not eligible for more intensive treatment (e.g. OptiMATe trial).
- •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.
- •Disease exclusively located in the CNS.
- •At least 1 measurable lesion.
- •ECOG-Performance Status ≤
- •Patients possibly eligible for HCT-ASCT as judged by the treating physician.
- •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:
- •Patients eligible for HCT-ASCT defined by the EBL score (at most 1 of the 3 following conditions may apply: ECOG PS > 1, Barthel Index of ADL < 20 and Lachs geriatric screening > 3), improvement of PS after prephase treatment or clinical judgement by the treating physician after discussion with the study expert team.
- •No evidence of disease progression after pre-phase treatment.
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.
- •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.
- •Previous systemic Non-Hodgkin lymphoma at any time.
- •Inadequate renal function (creatinine clearance <60 ml/min).
- •Inadequate bone marrow, cardiac, pulmonary or hepatic function according to investigator´s decision.
- •Active hepatitis B or C disease.
- •Concurrent treatment with other experimental drugs or participation in an interventional clinical trial with administration of study medication 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 likely to cause interactions with the study medication.
- •Known or persistent abuse of medication, drugs or alcohol.
- •Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic.
- •Patients without legal capacity and who are unable to understand the nature, significance and consequences of the study and without designated legal representative.
- •Previous participation in this trial.
- •Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator.
- •Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •Fertile patients refusing to use safe contraceptive methods during the study.
结局指标
主要结局
Progression free survival
Progression free survival
次要结局
- • Overall survival (OS) • Event free survival (EFS; defined as time from randomization to premature end of treatment (EOT) due to any reason, lymphoma progression or death, whichever occurs first) • Remission during and after induction treatment • Remission after maintenance: 6 months after RAII • Quality of life (QoL): EORTC QLQ-C30, EORTC QLQ-BN20; measured during screening period, at RAII and premature EOT visit and thereafter every 12 months during follow-up.
研究者
PD Dr. med. Elisabeth Schorb
Scientific
Medical Center - University Of Freiburg
研究点 (43)
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