Chidamide Plus R-CHOP (CR-CHOP) in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes: A Prospective, Multicenter Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Evaluation of the Safety and Efficacy of CR-CHOP Treatment in Newly Diagnosed Double-Expressor DLBCL with Other Molecular Subtypes
详细描述
Patients with the Other Molecular Subtype of double-expressor diffuse large B-cell lymphoma (DEL-DLBCL) demonstrate significantly poorer survival outcomes. The DEB trial demonstrated that chidamide combined with R-CHOP significantly improves the complete response (CR) rate in DEL patients and shows a definitive trend toward benefit in event-free survival (EFS). Therefore, we plan to evaluate the efficacy and safety of C-R-CHOP (chidamide plus R-CHOP) in treating DLBCL patients with the DEL Other molecular subtype.
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
- •Patients must meet all of the following inclusion criteria to be eligible for enrollment:
- •≥18 years of age;
- •Diffuse large B-cell lymphoma diagnosed by pathological diagnosis according to WHO 2016 classification criteria;
- •Molecular subtyping, determined through high-throughput sequencing of pathological tissue or peripheral blood, is categorized as the "Other" subtype;
- •Immunohistochemistry revealed overexpression of MYC and BCL2: MYC ≥ 40%, BCL2 ≥ 50%;
- •Measurable lesions identified on cross-sectional imaging through diagnostic modalities (computed tomography [CT] or magnetic resonance imaging [MRI]) are defined as the presence of at least one two-dimensional lesion with a maximum cross-sectional diameter (GTD) ≥1.5 cm, irrespective of the short-axis diameter;
- •The Eastern Cooperative Oncology Group (ECOG) performance status score is ≤2；
- •Adequate hepatic function is defined as: total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN; alkaline phosphatase (ALP) ≤ 5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 35 mL/min as calculated by the Cockcroft-Gault formula;
- •Voluntary participation with willingness to provide the aforementioned treatment data, accompanied by a signed and dated informed consent form.
排除标准
- •Patients who meet any of the following criteria will be excluded from the study：
- •Currently enrolled in another clinical trial；
- •Received prior lymphoma treatment with alternative regimens before enrollment;
- •Presence of concurrent malignant tumors;
- •Deemed ineligible for participation by the investigator's judgment；
- •Presence of severe psychiatric or neurological disorders that may impair the ability to provide informed consent and/or affect the reporting or observation of adverse events；
- •Patients unable to comply with follow-up requirements；
- •Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception;
- •Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive and HBV DNA positive), HCV positive
研究组 & 干预措施
CR-CHOP arm
Newly Diagnosed DEL Patients Receiving Chidamide plus R-CHOP(Rituximab、Cyclophosphamide、Doxorubicin、Vincristine and Prednisone) Regimen Treatment
干预措施: Chidamide plus R-CHOP (Drug)
结局指标
主要结局
PFS
时间窗: 2 years
from date of inclusion to date of progression, relapse, or death from any cause
次要结局
- ORR(up to 6 cycles (each cycle is 21 days))
- CR rate(up to 6 cycles (each cycle is 21 days))
- OS(2 years)