2025-523389-26-00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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 49
- 主要终点
- 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.
研究概览
简要总结
To investigate the efficacy of tirabrutinib monotherapy versus rituximab-temozolomide (R-TMZ) combination therapy as measured by progression-free survival (PFS) based on blinded Independent Review Committee (BIRC) assessment according to International Primary Central Nervous System Lymphoma Collaborative Group (IPCG) Criteria.
研究设计
- 分配方式
- Na
- 主要目的
- Follow-up Period
- 盲法
- None
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
- 否
入选标准
- •Written informed consent by the participant or legal authorized representative prior to Screening.
- •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-
- •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 mg/day of prednisone for a disease other than PCNSL • Equivalent of up to 50 mg/day of prednisone (equal to 8 mg/day of dexamethasone) for participants with lesions of the brain or spinal cord or both.
- •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
Truxima 500 mg concentrate for solution for infusion, Truxima 100 mg concentrate for solution for infusion
Comparator
干预措施: Truxima 500 mg concentrate for solution for infusion (Drug)
Truxima 500 mg concentrate for solution for infusion, Truxima 100 mg concentrate for solution for infusion
Comparator
干预措施: Truxima 100 mg concentrate for solution for infusion (Drug)
Temomedac 20 mg hard capsules, Temomedac 5 mg hard capsules, Temomedac 100 mg hard capsules
Comparator
干预措施: Temomedac 5 mg hard capsules (Drug)
Tirabrutinib
Test
干预措施: Tirabrutinib (Drug)
Temomedac 20 mg hard capsules, Temomedac 5 mg hard capsules, Temomedac 100 mg hard capsules
Comparator
干预措施: Temomedac 20 mg hard capsules (Drug)
Temomedac 20 mg hard capsules, Temomedac 5 mg hard capsules, Temomedac 100 mg hard capsules
Comparator
干预措施: Temomedac 100 mg hard capsules (Drug)
结局指标
主要结局
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.
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
- ORR based on BIRC per IPCG criteria, defined as the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR).
- OS, defined as the time from randomization until death due to any cause.
- CRR, BOR, TTR, TTCR, DOR, and DFS by BIRC: CRR based on BIRC per IPCG criteria, defined as the percentage of participants with a best overall response of CR or CRu
- BOR based on BIRC per IPCG criteria, defined as the best response from randomization to the date of PD or the date of initiation of subsequent anticancer therapy for PCNSL, whichever occurs first.
- TTR based on BIRC per IPCG criteria, defined as time between randomization and the date of first response of CR, CRu, or PR.
- TTCR based on BIRC per IPCG criteria, defined as the time between randomization and the date of first complete response (CR or CRu).
- DOR based on BIRC per IPCG criteria, defined as the time between the date of first response (CR, CRu, or PR) and the date of the first PD or date of death due to any cause, whichever occurs first.
- DFS based on BIRC per IPCG criteria, defined as the time between the date of first complete response (CR or CRu) and the date of the first PD, or date of death due to any cause, whichever occurs first.
- Change from baseline in Corticosteroid dose
研究者
Clinical Trial Information
Scientific
Deciphera Pharmaceuticals Inc.
研究点 (49)
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