A Multi-center, Single-arm, Open Label Study to Assess the Efficacy and Safety of Anti-PD-1 Antibody (Penpulimab) Plus Lenalidomide, Rituximab, Gemcitabine and Oxaliplatin (R2-GemOx) in Patients With Relapsed/ Refractory Diffuse Large B Cell Lymphoma (DLBCL)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Complete response rate
研究概览
简要总结
This study evaluates the efficacy and safety of penpulimab plus lenalidomide, rituximab, gemcitabine and oxaliplatin (R2-GemOx) in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL). All patients will receive six cycles of penpulimab plus R2-GemOx. Afterwards, 1) patients who achieve complete response (CR)/unconfirmed (CRu)/partial response (PR) assessed by positron emission tomography/computedtomography (PET-CT) and are eligible for autologous stem cell transplantation (ASCT) will undergo ASCT. 2) Patients who achieve CR/CRu/PR assessed by PET-CT and are not eligible for ASCT will directly receive penpulimab and lenalidomide as maintenance treatment, penpulimab for a maximum of 6 months, lenalidomide monotherapy for 18 months. 3) Patients achieved stable disease (SD) or progression disease (PD) assessed by PET-CT will withdraw from this study and receive proper treatment based on investigator's decision.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed CD20+ diffuse large B-cell lymphoma
- •Age range from 18 to 80 years;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Expectation survival time over 3 months;
- •According to Lugano 2014, at least one measurable nodular lesion with a length of greater than 15 mm, or extranodal lesion greater than 10 mm, lesion on FDG-PET scan demonstrates uptake);
- •Diffuse large B-cell lymphoma patients failed to first-line rituximab based chemotherapy including anthracycline or anthracycline
- •Patients are allowed to receive palliative radiotherapy, but the last time radiotherapy cannot be within 7 days before the first study drug administration;
- •Adequate organ function
- •Willingness to provide written informed consent.
排除标准
- •Pregnant or lactating women;
- •Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months;
- •Patients with autoimmune diseases requiring treatment or with a history of syndrome requiring systemic use of steroid immunosuppressive agents, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc;
- •Patients received systemic glucocorticoid therapy (excluding nasal spray, inhaled or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first administration;
- •Uncontrolled heart disease, including unstable angina pectoris, acute myocardial infarction 6 months before randomization, congestive heart failure (NYHA) heart function grade III or IV; or left ventricular ejection fraction of the heart <50% ；
- •Patients are allergic to penpulimab, lenalidomide, CD20 monoclonal antibody and GemOx regimen
- •Patients who have had previous organ transplants (except autologous hematopoietic stem cell transplants);
- •History of other malignancy within the past 5 years (except for
- •basal cell carcinoma of the skin and
- •carcinoma in situ of the cervix and
- •patients who had received treatment for the purpose of cure and had not developed a malignant tumor with a known active disease in the previous 5 years);
- •Those who have had neurotoxicity of grade 3 or above within two weeks before treatment;
- •Severe or uncontrolled infections;
- •Patients with drug abuse, medical, psychological or social conditions that may interfere with the study results or the assessment of the study results;
- •Patients are unsuitable for the enrollment according to investigator's judgement.
研究组 & 干预措施
penpulimab, lenalidomide, rituximab, gemcitabine and oxaliplatin（Penpulimab-R2-GemOx)）
penpulimab: 200 mg q2w, iv, drip R2-GemOx: lenalidomide 10 mg，po; Rituximab 375mg/m2, iv, drip; Gemcitabine 1000mg, po; Oxaliplatin 100mg/m2, iv, drip;
干预措施: penpulimab, lenalidomide, Rituximab, Gemcitabine, Oxaliplatin (Drug)
结局指标
主要结局
Complete response rate
时间窗: 6 weeks after the last dose of the combination therapy (each cycle is 14 days)
Complete response rate after treated by penpulimab and R2-GemOx
次要结局
- Rate of grade 3 or 4 treatment related adverse effect(Up to 30 days after the last cycle of per-protocol treatment and 90 days after last dose of anti-PD-1 antibody)
- Overall Survival (OS)(2 years)
- Progression-free survival（PFS）(2 years)