Efficacy and Safety of Glofitamab Combined With GemOx (Gemcitabine and Oxaliplatin) in the Treatment of Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Complete Response Rate
研究概览
简要总结
In patients with relapsed or refractory diffuse DLBCL who have not achieved complete remission in the mid-term, the treatment with Glofit+GemOx regimen is used.
详细描述
Efficacy and Safety of Glofitamab Combined with GemOx (Gemcitabine and Oxaliplatin) in the Treatment of Refractory Diffuse Large B-Cell Lymphoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •DLBCL confirmed by pathological diagnosis according to the WHO 2016 classification;
- •PET-positive (Deauville score 4-5) according to Lugano response criteria after 3 cycles of first-line treatment;
- •No history or evidence of central nervous system involvement;
- •Adverse reactions from prior treatments have recovered to grade 1 or below (excluding clinically insignificant reactions such as hair loss);
- •ECOG performance status score ≤ 2;
- •Adequate bone marrow, kidney, liver, respiratory, and cardiac function: absolute neutrophil count ≥ 1000/μL; platelet count ≥ 75,000/μL; absolute lymphocyte count ≥ 100/μL; creatinine clearance ≥ 60 mL/min; ALT and AST ≤ 2.5 times the upper limit of normal; total bilirubin ≤ 1.5 mg/dL (except for Gilbert's syndrome); cardiac echocardiography showing ejection fraction ≥ 50% with no pericardial effusion (small or physiological effusions excluded); no clinically significant serosal effusions; baseline oxygen saturation > 92%;
- •The subject is able to understand the study protocol, is willing to participate in this study, and provides written informed consent.
排除标准
- •History of malignant tumors, excluding non-melanoma skin cancers or carcinoma in situ (cervix, bladder, breast), unless the disease has been in remission for at least 3 years;
- •Uncontrolled fungal, bacterial, viral, or other infections requiring intravenous anti-infective therapy;
- •Human immunodeficiency virus (HIV) infection, or acute/chronic active hepatitis B or C infection;
- •Malignant cells detectable in cerebrospinal fluid or active CNS lymphoma;
- •History of myocardial infarction, coronary artery bypass graft, or stent implantation within 12 months prior to enrollment;
- •History of deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment;
- •Female patients who are pregnant or breastfeeding, as determined by the investigator;
- •Inability of the subject to complete the study protocol or visits;
- •Presence of uncontrollable infection;
- •Currently participating in interventional study treatment, or having received other investigational drugs within 4 weeks prior to first dose (previous treatment with cetuximab, oxaliplatin, and gemcitabine is included);
- •Any other condition that the investigator deems the patient unsuitable for this trial.
研究组 & 干预措施
Refractory diffuse large B-cell lymphoma
1）. Age ≥18 years; 2）. DLBCL confirmed by WHO 2016 pathological classification; 3）. After 3 cycles of first-line treatment, PET-positive according to Lugano response criteria (Deauville score 4-5); 4）. No history or evidence of central nervous system involvement;
干预措施: Glofitamab (Drug)
Refractory diffuse large B-cell lymphoma
1）. Age ≥18 years; 2）. DLBCL confirmed by WHO 2016 pathological classification; 3）. After 3 cycles of first-line treatment, PET-positive according to Lugano response criteria (Deauville score 4-5); 4）. No history or evidence of central nervous system involvement;
干预措施: Gemcitabin (Drug)
Refractory diffuse large B-cell lymphoma
1）. Age ≥18 years; 2）. DLBCL confirmed by WHO 2016 pathological classification; 3）. After 3 cycles of first-line treatment, PET-positive according to Lugano response criteria (Deauville score 4-5); 4）. No history or evidence of central nervous system involvement;
干预措施: Oxaliplatin (Drug)
Refractory diffuse large B-cell lymphoma
1）. Age ≥18 years; 2）. DLBCL confirmed by WHO 2016 pathological classification; 3）. After 3 cycles of first-line treatment, PET-positive according to Lugano response criteria (Deauville score 4-5); 4）. No history or evidence of central nervous system involvement;
干预措施: Obinutuzumab (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: From enrollment to the end of treatment at 8 weeks
Refers to the proportion of patients whose all detectable target lesions (such as tumor lesions or affected tissues) have completely disappeared after treatment with Glofitamab combined with GemOx, and this state lasts for at least 4 weeks. This condition needs to be confirmed through imaging examinations (such as CT, MRI, or PET-CT) and assessed comprehensively in combination with ctDNA.
次要结局
- ORR(From enrollment to the end of treatment at 8 weeks)
- OS(From enrollment to the end of treatment at 8 weeks)
- PFS(From enrollment to the end of treatment at 8 weeks)
- DoR(From enrollment to the end of treatment at 8 weeks)