A Single-arm, Multicenter Phase II Clinical Study of HiR+X Therapy for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL) in Elderly Patients Intolerant to Chemotherapy, Guided by Molecular Subtyping and Clinical Characteristics.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Complete response rate (CR) at the end of 6 cycles
研究概览
简要总结
To explore the application of HiR (Zebtorizumab, Lenalidomide) + X (targeted drug) guided by NGS molecular typing, the aim is to assess the therapeutic efficacy and safety in newly diagnosed unfit or frail elderly patients with DLBCL aged ≥70 years, and to investigate the genetic subtypes that may benefit from HiR-X.
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
- 70 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years;
- •ECOG score 0-3;
- •Rated as "unfit" or "frail" on the simplified geriatric assessment (sGA);
- •Histologically confirmed CD20-positive diffuse large B-cell lymphoma [diagnostic criteria according to WHO 2016], excluding transformed type 2 DLBCL;
- •Previously untreated, newly diagnosed patients;
- •Cardiac, hepatic, and renal function: creatinine < 2 times the upper limit of normal (ULN); ALT (alanine aminotransferase) / AST (aspartate aminotransferase) < 2.5 x ULN; total bilirubin < 2 x ULN;
- •At least one measurable lesion;
- •Intolerance to standard CHOP chemotherapy regimen or unwillingness to receive chemotherapy;
- •Sufficient understanding and voluntary signing of the informed consent form.
排除标准
- •Patients with central nervous system involvement at the onset of the disease;
- •Known human immunodeficiency virus (HIV) infection;
- •Pregnant or lactating women;
- •Other tumors requiring treatment;
- •Uncontrolled active infection;
- •Active hepatitis with HBV-DNA copy number unable to be controlled within 2000/mL despite antiviral treatment;
- •Individuals who cannot understand, comply with the study protocol, or sign the informed consent form.
研究组 & 干预措施
Patients with newly diagnosed, CD20+, elderly, chemotherapy-intolerant DLBCL
All patients will receive one cycle of HiR (Zebtorizumab, Lenalidomide) induction therapy. On the first day of enrollment, tissue NGS and peripheral blood ctDNA will be submitted for testing. For the remaining six cycles, the added drug (X) will be determined based on the NGS molecular typing results. Please refer to the grouping scheme for details.
HiR+X Dosing Scheme:
Hi: Zebtorizumab 375mg/m², d1; R: Lenalidomide 10-25mg d1-10 (maximum tolerated dose)
X:
For MCD/BN2/TP53: Ocalivumab 150mg qd For EZB: Chidamide 30mg biw
For N1-like and nonspecific types:
If EBV-positive: PD-1 monoclonal antibody 200mg Q3W
干预措施: Drug therapy (Drug)
结局指标
主要结局
Complete response rate (CR) at the end of 6 cycles
时间窗: Each cycle consists of 21 days, with a total of 6 cycles.
Complete response rate (CR) at the end of 6 cycles
次要结局
未报告次要终点
研究者
Lixia Sheng
Chief Physician
First Affiliated Hospital of Ningbo University