NCT07585747尚未招募2 期
A Multicenter Exploratory Clinical Study on the Treatment of Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide
Institute of Hematology & Blood Diseases Hospital, China5 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2026年4月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 27
- 试验地点
- 5
研究概览
简要总结
Evaluate the efficacy and safety of orelabrutinib, tafasitamab, and lenalidomide in the first-line treatment of patients with follicular lymphoma.
详细描述
Follicular lymphoma (FL) is the most common indolent non-Hodgkin's lymphoma (NHL), accounting for 35% of NHL cases . The median age at diagnosis is 65 years , and most patients are diagnosed at an advanced stage. Although FL is still considered incurable, the clinical prognosis for most patients remains favorable.Currently, there is some data available for BTKi and tafasitamab in relapsed/refractory follicular lymphoma, and further exploration of relevant data in the first-line setting is needed. This combination therapy may provide new options for patients with follicular 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, regardless of gender;
- •Newly diagnosed patients with follicular lymphoma (Grade 1, 2, or 3a) confirmed histologicallyaccording to the World Health Organization (WHO) classification of diseases;
- •Deemed by the investigator to have an indication for treatment and require therapy;
- •ECOG performance status score of 0-2;
- •Laboratory tests meeting the following criteria:
- •Bone marrow hematopoietic function is essentially normal: WBC 3.5x10^9/L, ANC > 1.0x10^9/L, PLT > 75x10^9/L, Hb > 80 g/L;
- •Liver function: AST/ALT s 2xULN, TBILI s 2xULN;
- •Renal function: Creatinine clearance rate > 50 ml/min;
- •Presence of at least one measurable lesion: Lymph node lesion with a long diameter > 1.5 cm orextranodal lesion with a long diameter > 1.0 cm as shown by PET/CT, CT, or MRl, or a lesion > 2cm assessed by clinical examination;
- •7. Ability to provide written informed consent.
排除标准
- •Women with a positive serum pregnancy test or who are breastfeeding;
- •Patients with lymphoma involving the central nervous system (CNS);
- •Clinically significant heart disease, including unstable angina, acute myocardial infarction within6 months prior to randomization, congestive heart failure with New York Heart Association(NYHA) functional class IIl or IV, or left ventricular ejection fraction <50%;
- •Patients with grade >2 neuropathy;
- •Patients with active hepatitis B (HBV, hepatitis C (HCV, or other acquired/congenitalimmunodeficiency diseases;
- •Patients with severe active infections requiring systemic antibiotic treatment;
- •Patients with a history of severe neurological or psychiatric disorders that impair trialparticipation, including dementia, epilepsy, severe depression, and mania;
- •Drug abuse, or medical, psychological, or social conditions that may interfere with studyparticipation or result evaluation;
- •9. Patients deemed ineligible by the investigator.
研究者
研究点 (5)
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