NCT05347641尚未招募2 期
A Single-arm, Prospective, Single-center, Phase II Clinical Study of Penpulimab Combined With RMA in the Treatment of Newly Diagnosed Primary CNS Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 23
- 主要终点
- 2-year PFS rate of PCNSL patients treated with penpulimab combined with RMA
研究概览
简要总结
To explore PFS, ORR (CR/CRu+PR), OS and side effects of piamprizumab combined with RMA in newly diagnosed PCNSL, so as to clarify the value of piamprizumab combined with RMA in the first-line treatment of PCNSL patients, and to clarify the clinical and biological factors affecting the efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For initial PCNSL confirmed by pathological tissue, the diagnostic criteria were based on WHO diagnostic criteria in 2016
- •Head MR (plain scan + enhancement) performed 28 days prior to study enrollment should show the presence of at least one measurable lesion in two vertical directions (according to 2014 Lugano criteria); Or abnormal cerebrospinal fluid examination (including cerebrospinal fluid protein, cells, NGS), or ophthalmologic examination confirmed the retina, vitreous lesions
- •PS score was 0~4 according to ECOG
排除标准
- •Organs or lymph nodes outside the central nervous system are involved
- •Patients with a second primary tumor (other than non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal cancer or breast cancer that has been cured and has not recurred within 5 years)
- •Has a history of allergic disease, severe drug allergy, or is known to be allergic to any component of a macromolecular protein preparation or penpulimab injection prescription
- •Prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CTLA-4 antibody, or CAR T cell therapy (or any other antibody that acts on T cell co-stimulation or checkpoint pathways)
- •A severe acute or chronic infection requiring systemic treatment
- •The investigator believes that the subjects may have other factors that affect the efficacy or safety evaluation of the study
研究组 & 干预措施
Penpulimab combined with RMA was used for first-line treatment of PCNSL
Experimental
One course of treatment was performed every 21 days. After 3 courses, patients underwent cranial MR+ whole-body enhanced CT for disease assessment. Patients who did not achieve partial response (PR) were withdrawn, and patients who achieved PR or complete response (CR)/uncertain CR (CRu) were given 3 courses of treatment.
干预措施: Penpulimab (Drug)
结局指标
主要结局
2-year PFS rate of PCNSL patients treated with penpulimab combined with RMA
时间窗: 2 years
次要结局
- ORR, 2-year OS rate and safety of penpurlimab combined with RMA in first-line treatment of PCNSL patients(2 years)
研究者
相似试验
进行中（未招募）
2 期
Nivolumab Plus Ramucirumab in Patients With Recurrent, Advanced, Metastatic NSCLCNon Small Cell Lung CancerNCT03527108Fox Chase Cancer Center36
招募中
不适用
Piamprilizumab (AK105) Combined With Radiotherapy for Neoadjuvant Treatment of Soft Tissue SarcomaSoft Tissue SarcomaNCT05718778Henan Cancer Hospital31
已完成
3 期
RAMucirumab in Combination Wth TAS102 vs. TAS102 Alone in Chemotherapy Refractory Metastatic Colorectal Cancer PatientsColorectal CancerNCT03520946Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest430
已完成
2 期
Study in Patients With Primary Breast Diffuse Large B-cell LymphomaLarge B Cell Diffuse LymphomaNCT01448096Chonbuk National University Hospital33
进行中（未招募）
2 期
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin CancerCutaneous Squamous Cell CarcinomaAdvanced Cutaneous Squamous Cell CarcinomaMetastatic Cutaneous Squamous Cell CarcinomaNCT04050436Replimune Inc.231