A Prospective Phase II Clinical Study of Orelabrutinib in Combination With Lenalidomide and Rituximab (OLR) in First-line Treatment of Mantle Cell Lymphoma
试验速览
- 阶段
- 2 期
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Complete Response Rate
研究概览
简要总结
This is a single-arm, multicenter, open label phase II clinical study to evaluate the efficacy and safety of OLR in the treatment of initially treated mantle cell lymphoma.
详细描述
Patients initially treated with mantle cell lymphoma were screened for OLR regimen according to study admission criteria. The study will accept up to 24 cycles of treatment until disease progression or intolerable toxicity occurs and subjects voluntarily withdraw informed consent. Patients undergoing hematopoietic stem cell transplantation after complete remission may begin stem cell collection after induction therapy for at least 6 months. Twenty-nine patients are expected to be enrolled
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed mantle cell lymphoma with chromosomal translocation. All subjects must provide adequate archived or fresh tumor tissue samples for immunohistochemistry (IHC) testing.
- •Age 18-70, both male and female.
- •No previous systemic treatment for lymphoma.
- •Have at least one measurable lesion. Measurable disease was defined as measurable tumor masses ≥1.5 cm in one or both dimensions and measurable spleen lesions.
- •Eastern Oncology Collaboration group physical status score was 0-
- •Adequate hematological function
- •Life expectancy >3 months.
- •Have the ability to provide written informed consent and understand and comply with study requirements.
- •Ability to adhere to research visit schedules and other protocol requirements
排除标准
- •Histology conformed blastolytic mantle cell lymphoma and polymorphic mantle cell lymphoma.
- •Patients with current or suspected central nervous system involvement and history of this disease
- •Received Bruton's tyrosine kinase inhibitor treatment
- •Receive lenalidomide treatment
- •Received other anti-tumor treatments
- •Major surgery within 4 weeks prior to screening.
- •Have a history of other active malignant diseases within 2 years prior to study entry,
- •Systemic fungal, bacterial or viral infection with uncontrolled activity
- •The following serological states are known for human immunodeficiency virus (HIV) infection or suggest the presence of active hepatitis B or C virus infection
- •Clinically serious cardiovascular disease
- •A history of severe hemorrhagic disorders, such as hemophilia A, hemophilia B, von willebrand disease, or A history of spontaneous bleeding requiring blood transfusion or other medical intervention.
- •A history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months.
- •A history of major cerebrovascular disease/event, including stroke or intracranial hemorrhage, in the 6 months prior to first administration of the study drug.
- •Anticoagulant therapy with warfarin or an equivalent vitamin K antagonist or anticoagulant therapy is required within 7 days of initial use of the study drug.
- •Pregnant or lactating women
- •Hypersensitivity to any study drug
- •The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator considers to be likely to affect the safety of the subject or cause risk
研究组 & 干预措施
Orelabtutinib in combination of rituximab and lenalidomide(OLR) Arm
Induction phase of mantle cell L lymphoma: Orelabrutinib: 150mg QD D1-28; Lenalidomide: Cycle 1: 15mg QD D1-21, if no dose-limiting toxicity occurred in Cycle 1, cycle 2-6: 20mg QD D1-21; Cycle 1: 375 mg/m2 d1, 8,15,22; Cycle 3, 5: 375 mg/m2 D1 Maintenance treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: cycle 7-24: 15mg QD D1-21; Cycle 7, 9, 11, 13, 15, 17, 19, 21, 23: 375 mg/m2 D1
干预措施: Orelabrutinib in in combination of rituximab and lenalidomide(OLR) (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: At the end of Cycle 6(each cycle is 28 days)
The proportion of patients receiving the treatment with complete remission
次要结局
- Objective Response Rate(Approximately 2 years)
- The Progression Free Survival Rate in 2 Years(2 Years)
- Time to Response(Approximately 1 year)
- The Overall Survival Rate in 2 Years(2 Years)