jRCT1031250645招募中不适用
JCOG2314: A phase II/III randomized trial of salvage treatment for Refractory PCNSL using Tirabrutinib (ReSTART)
未提供0 个研究点目标入组 94 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Histologically proven diffuse large B-cell lymphoma from surgical resection or biopsy of an intracranial lesion.
- •(2) Primary lesion exists in the central nervous system (CNS)-the cerebrum, cerebellum, or brainstem-excluding the spinal cord.
- •(3) No lesions are detected outside the CNS and the intraocular region on contrast-enhanced computed tomography (CT) from the neck to the groin or whole-body PET performed before the initiation of induction therapy.
- •(4) Single or multiple lesions are allowed.
- •(5) Aged 18 years and older.
- •(6) Eastern Cooperative Oncology Group (ECOG) PS of 0-2, or 3 due to neurological symptoms caused by the tumor.
- •(7) Residual intracranial lesions confirmed on contrast-enhanced brain magnetic resonance imaging (MRI) at registration.
- •(8) Cerebrospinal fluid (CSF) cytology at registration confirms either the absence of lymphoma cells or equivocal findings. Patients for whom CSF examination is contraindicated are eligible if both contrast-enhanced brain MRI and whole-spine MRI demonstrate no evidence of leptomeningeal dissemination.
- •(9) At registration, patients have received one of the MTX-based induction regimens described in (i)-(iv) below for PCNSL and have been diagnosed with PD on contrast-enhanced brain MRI during induction therapy. Alternatively, patients are eligible if they have completed >= 5 cycles (up to 7 cycles) of one of the MTX-based induction regimens described in (i)-(iv) below, have been assessed as PR or SD on contrast-enhanced brain MRI, and are considered to require salvage therapy.
- •(i) R-MPV regimen: rituximab, methotrexate, and vincristine each administered 1-7 times, and procarbazine administered at least once.
- •(ii) MPV regimen: methotrexate and vincristine each administered 1-7 times, and procarbazine administered at least once.
- •(iii) R-M regimen: rituximab and methotrexate each administered 1-7 times.
- •(iv) M regimen: methotrexate administered 1-7 times.
- •(10) Within 30 days after the last day of induction therapy.
- •(11) No prior radiotherapy (RT) for PCNSL.
- •(12) No prior chemotherapy or RT for other malignancies or lymphoma. However, hormone therapy for prostate or breast cancer is allowed. RT alone for prostate cancer, breast cancer, or early glottic cancer is allowed if >= 5 years have passed without recurrence.
- •(13) All of the following laboratory values are met.
- •(i) Neutrophil count >= 1,000 /mm3
- •(ii) Hemoglobin >= 8.0 g/dl
- •(iii) Platelet count >= 75,000 /mm3
- •(iv) AST <= 100 U/L
- •(v) ALT <= 100 U/L
- •(vi) T-bil <= 2.25 mg/dL
- •(vii) Serum creatinine <= 1.5 mg/dL
- •(14) Written informed consent.
排除标准
- •(1) Simultaneous or metachronous (within two years) double cancers, with the exception of intramucosal tumor curable with local therapy.
- •(2) Active infection requiring systemic therapy.
- •(3) Fever over 38 degrees Celsius.
- •(4) Female during pregnancy, within 28 days of post parturition, or during lactation.
- •(5) Psychological disorder difficult to participate in this clinical study.
- •(6) Receiving continuous systemic corticosteroid or immunosuppressant treatment due to the diseases except for brain tumors.
- •(7) Uncontrolled diabetes mellitus.
- •(8) History of unstable angina pectoris within three weeks or myocardial infarction within 6 months before registration.
- •(9) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT.
- •(10) Gadolinium allergy.
- •(11) Positive HBs antigen.
- •(12) Positive HIV antibody.
研究者
相似试验
招募中
不适用
AZD0486 1L Therapy for Elderly or Unfit Participants with LBCLLarge B-cell LymphomajRCT203125054640
招募中
1 期
A Multicentre, Randomised Phase Ib Trial to evaluate Neoadjuvant Immunotherapy Combination of Nivolumab alone or plus Ipilimumab with the IL-2 Superkine MDNA11 alone or with Tocilizumab in Patients with High-Risk, Surgically Resectable Melanoma – NEO-CYT2024-519010-31-00Fondazione Melanoma Onlus80
招募中
不适用
A Phase I/II exploratory clinical trial to evaluate the efficacy and safety of RBBM-S1 in patients requiring lumbar interbody fusion for degenerative lumbar disease, in comparison with the standard treatment of autologous bone grafting.lumbar stenosis, spondylolisthesis, spondylolysis, scoliosis, instability, disc diseasejRCT203125056936
招募中
1 期
Single-centre clinical trial investigating the safety and tolerability of increasing multiple doses of nebulised SS0331 in healthy participants2025-523530-30-00Softox Defense Solutions AS48
招募中
不适用
A Phase I/II, multicenter study to evaluate the safety, tolerability, pharmacokinetics characteristics, and efficacy of CYH33 in patinets with PIK3CA related overgrowth spectrum (PROS) and PIK3CA related vascular malformations (PRVM) (A Phase I/II study of CYH33 in Patients with PROS and PRVM)PIK3CA-Related Overgrowth Spectrum (PROS) and PIK3CA-Related Vascular Malformations (PRVM)jRCT204125016881