NCT07104032招募中3 期
A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants With Relapsed/Refractory Primary Central Nervous System Lymphoma
Ono Pharmaceutical Co., Ltd.35 个研究点 分布在 7 个国家目标入组 132 人开始时间: 2026年6月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 35
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathology report confirming the diagnosis of B-cell PCNSL
- •Relapsed or refractory B-cell PCNSL with at least 1 prior high-dose methotrexate (HD-MTX) based therapy for PCNSL:
- •Relapsed disease: Participants who achieved a response (CR, CRu, PR) to the last treatment and subsequently experienced disease progression.
- •Refractory disease: Participants whose best response to the last treatment was stable disease or PD.
- •One or more bi-dimensionally measurable brain lesions with a minimum diameter greater than or equal to (≥)1 centimeter (cm) × ≥1 cm in gadolinium-enhanced magnetic resonance imaging (MRI)
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
- •Adequate bone marrow, renal, and hepatic function per central lab values
- •Participants must agree to comply with all defined contraceptive requirements
排除标准
- •Participants with isolated intraocular PCNSL or spinal PCNSL with no brain lesions
- •Participants with non-B-cell PCNSL
- •Participants with systemic presence of lymphoma
- •Refractory to temozolomide with or without rituximab-containing regimens in the last PCNSL treatment
- •Concomitant systemic corticosteroid exposure within 14 days before starting study drug per Investigator assessment with the exception of the following:
- •Equivalent of up to 10 milligram per day (mg/day) of prednisone for a disease other than PCNSL
- •Equivalent of up to 50 mg/day of prednisone (equal to 8 mg/day dexamethasone) for participants with lesions of the brain and/or spinal cord
- •Active malignancy, other than PCNSL requiring systemic therapy
- •Poorly controlled comorbidity, or history of medical conditions contraindicated per Investigator assessment
- •Participants who are unable to swallow oral medication
- •Prior Bruton's tyrosine kinase inhibitor treatment
研究组 & 干预措施
Rituximab-Temozolomide (R-TMZ)
Active Comparator
Rituximab 375 milligram per square meter (mg/m2) intravenously (IV) and temozolomide 150 mg/m2/day orally, as combination therapy for Cycle 1 through 6.
干预措施: Temozolomide (Drug)
Tirabrutinib
Experimental
Tirabrutinib 480 milligram (mg) orally every day (QD), as monotherapy in 28-day cycles.
干预措施: Tirabrutinib (Drug)
Rituximab-Temozolomide (R-TMZ)
Active Comparator
Rituximab 375 milligram per square meter (mg/m2) intravenously (IV) and temozolomide 150 mg/m2/day orally, as combination therapy for Cycle 1 through 6.
干预措施: Rituximab (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Estimated up to 24 months
PFS based on blinded Independent Review Committee (BIRC) assessment according to International Primary Central Nervous System Lymphoma Collaborative Group (IPCG) criteria, defined as time from randomization to progressive disease (PD) or death due to any cause, whichever occurs first.
次要结局
- Overall Response Rate (ORR)(Estimated up to 48 months])
- Overall Survival (OS)(Estimated up to 48 months)
- Complete Response Rate (CRR)(Estimated up to 48 months)
- Best Overall Response (BOR)(Estimated up to 48 months])
- Time to Response (TTR)(Estimated up to 48 months)
- Time to Complete Response (TTCR)(Estimated up to 48 months)
- Duration of Response (DOR)(Estimated up to 48 months)
- Complete Response Rate (CRR)(Estimated up to 48 months)
- Overall Response Rate (ORR)(Estimated up to 48 months])
- Overall Survival (OS)(Estimated up to 48 months)
- Best Overall Response (BOR)(Estimated up to 48 months])
- Time to Response (TTR)(Estimated up to 48 months)
- Time to Complete Response (TTCR)(Estimated up to 48 months)
- Duration of Response (DOR)(Estimated up to 48 months)
- Disease Free Survival (DFS)(Estimated up to 48 months)
- Change from Baseline in Corticosteroid Dose(Baseline, estimated up to 48 months)
研究者
研究点 (35)
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