A Prospective, Single-Arm, Single-Center Clinical Study on the Maintenance Treatment of Young High-Risk Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) Patients With Pomalidomide Combined With Rituximab.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 27
- 主要终点
- 1-Year Progression-Free Survival Rate
研究概览
简要总结
This is a prospective, single-arm, single-center clinical study evaluating pomalidomide combined with rituximab as maintenance treatment in young high-risk patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) who have achieved at least a partial response after first-line therapy.
Eligible participants will receive rituximab 375 mg/m² by intravenous infusion on Day 1 every 8 weeks and pomalidomide 4 mg orally once daily on Days 1 to 21 of each 28-day cycle. Maintenance treatment is planned for 24 months unless disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria occur.
The main purpose of this study is to evaluate the efficacy and safety of this maintenance treatment approach. The primary outcome measure is the 1-year progression-free survival rate. Secondary outcome measures include conversion from partial response to complete response, duration of response, progression-free survival, overall survival, 1-year and 2-year overall survival rates, 2-year progression-free survival rate, minimal residual disease, complete molecular response, immune cell subsets, immune function markers, and adverse events.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and <60 years, male or female.
- •Histologically confirmed newly diagnosed diffuse large B-cell lymphoma (DLBCL), with at least a partial response (PR) after first-line therapy.
- •Age-adjusted International Prognostic Index (aaIPI) >1 at initial diagnosis.
- •Ann Arbor stage II-IV disease at initial diagnosis.
- •Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-
- •Adequate bone marrow hematopoietic function, defined as absolute neutrophil count ≥1.5 × 10^9/L, with granulocyte colony-stimulating factor support allowed; platelet count ≥75 × 10^9/L, with platelet transfusion allowed to reach this minimum platelet count; and hemoglobin ≥8.0 g/dL, with prior red blood cell transfusion or recombinant human erythropoietin allowed. If abnormal peripheral blood counts are caused by lymphoma involvement of the bone marrow or spleen, eligibility may be determined at the investigator's discretion.
- •Adequate major organ function, defined as total serum bilirubin ≤2.0 × upper limit of normal (ULN), serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN, and creatinine clearance >30 mL/min. For participants with hepatic involvement by lymphoma, eligibility may be determined at the investigator's discretion.
- •Expected survival of ≥3 months as judged by the investigator.
- •Ability to understand the study and willingness to provide written informed consent.
- •Female participants must use effective contraception, must not be pregnant, and must agree n
排除标准
- •Presence of another active malignancy that is untreated or currently being treated.
- •History of severe venous thromboembolism (VTE) or cerebral infarction before treatment.
- •Active hepatitis B or hepatitis C infection, or human immunodeficiency virus (HIV) seropositivity.
- •Uncontrolled or severe cardiovascular disease, including myocardial infarction within 3 months before enrollment, unstable coronary artery disease, uncontrolled chronic congestive heart failure, New York Heart Association (NYHA) class III-IV heart failure, or clinically significant pericardial disease.
- •Uncontrolled hypertension or diabetes mellitus.
- •Uncontrolled active infection or acute active infection.
- •Contraindication or allergy to any study drug.
- •Pregnant or breastfeeding women.
- •Any severe physical or psychiatric illness that, in the opinion of the protocol or the investigator, may interfere with participation in this clinical study; or any substance abuse, medical, psychological, or social condition that may interfere with study participation or assessment of study results.
- •Current treatment with other investigational drugs.
- •Participation in another clinical trial within 1 month before enrollment.
- •Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.
研究组 & 干预措施
Pomalidomide Plus Rituximab Maintenance
Participants with newly diagnosed high-risk diffuse large B-cell lymphoma who achieve at least a partial response after first-line treatment will receive maintenance therapy with pomalidomide plus rituximab for up to 24 months.
干预措施: Pomalidomide (Drug)
Pomalidomide Plus Rituximab Maintenance
Participants with newly diagnosed high-risk diffuse large B-cell lymphoma who achieve at least a partial response after first-line treatment will receive maintenance therapy with pomalidomide plus rituximab for up to 24 months.
干预措施: Rituximab (Drug)
结局指标
主要结局
1-Year Progression-Free Survival Rate
时间窗: At 1 year after the start of maintenance treatment
次要结局
未报告次要终点