CRP Regimen (Chidamide, Rituximab and Polatuzumab Vedotin) in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL: Single-Arm, Open-Label, Multicenter Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Complete Response Rate (CRR)
研究概览
简要总结
A Single-Arm, Open-Label, Multicenter Phase II Trial of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in Treating Elderly Patients with Previously Untreated Double-Positive Diffuse Large B-Cell Lymphoma
详细描述
This is a single-arm, open-label, multicenter Phase II trial to evaluate the feasibility, efficacy, and safety of the CRP regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in treating elderly patients with previously untreated double-expressor 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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥70 years, or patients aged 60-69 years with an ECOG performance status score of 2-
- •Both males and females are eligible.
- •No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy directed at the lymphoma (excluding palliative radiotherapy for symptom relief), or surgical therapy (excluding diagnostic biopsy or surgery not targeting the lymphoma).
- •Histopathological confirmation meeting all of the following conditions:
- •Diagnosis of diffuse large B-cell lymphoma (DLBCL) with CD20 positivity; concurrent positive expression of C-MYC and Bcl-2 (double-expressor phenotype).
- •At least one measurable lesion positive on ¹⁸F-FDG PET-CT scan according to the Lugano 2014 criteria for Hodgkin and non-Hodgkin lymphoma.
- •Laboratory tests at screening must meet the following criteria, unless the investigator attributes abnormalities to lymphoma (no corrective or supportive therapy for these parameters within 2 weeks prior to assessment):
- •Hematology: Hb ≥90 g/L, ANC ≥1.5 × 10⁹/L, PLT ≥90 × 10⁹/L.
- •Biochemistry: Cr ≤1.5 ×ULN; TBIL ≤1.5 × ULN; ALT and AST ≤2.5 × ULN (for patients with liver involvement: ≤5 × ULN).
- •Life expectancy of at least 6 months, as judged by the investigator.
- •Ability to understand and voluntarily provide written informed consent.
排除标准
- •History of or concurrent other active malignancies.
- •Prior treatment with Chidamide and/or R-CHOP. Contraindication to any component of CHOP, including prior anthracycline therapy. History of severe hypersensitivity or anaphylaxis to humanized or murine monoclonal antibodies, or known sensitivity/allergy to murine products.
- •Current diagnosis of any of the following: Follicular lymphoma grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey zone lymphoma); Primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; Central nervous system (CNS) lymphoma (primary or secondary); Primary effusion DLBCL; Primary cutaneous DLBCL, leg type.
- •History of myocardial infarction, unstable angina, or other clinically significant cardiac disease within 12 months prior to signing informed consent; or prior coronary angioplasty/stenting within 12 months.
- •Clinically uncontrolled active infection (bacterial, fungal, or viral) or organ hemorrhage.
- •Pregnant or lactating women.
- •Participation in any other clinical trial within 6 months prior to signing informed consent.
- •Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.
研究组 & 干预措施
Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten
Each subject will be given combination therapy of Chidamide, Rituximab and Polatuzumab Vedotin.The maximum number of treatment cycles is six.
干预措施: Rituximab (Drug)
Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten
Each subject will be given combination therapy of Chidamide, Rituximab and Polatuzumab Vedotin.The maximum number of treatment cycles is six.
干预措施: Polatuzumab Vedotin (Drug)
Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten
Each subject will be given combination therapy of Chidamide, Rituximab and Polatuzumab Vedotin.The maximum number of treatment cycles is six.
干预措施: Chidamide (Drug)
Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten
Each subject will be given combination therapy of Chidamide, Rituximab and Polatuzumab Vedotin.The maximum number of treatment cycles is six.
干预措施: Chidamide Maintenance (Drug)
结局指标
主要结局
Complete Response Rate (CRR)
时间窗: up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days
To assess the Complete Response Rate (CR) at the end of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin).
次要结局
- Overall Response Rate (ORR)(up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days)
- Progression-free survival (PFS)(up to 2 years)
- Event free survival(EFS)(up to 2 years)
- Overall Survival(OS)(up to 2 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(up to 2 years)
- Quality of Life Assessment - EORTC QLQ-C30 Score(up to 2 years)
- Quality of Life Assessment - FACT-Lym Score(up to 2 years)
研究者
Huilai Zhang
Study director
Tianjin Medical University Cancer Institute and Hospital