A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of iR2 (Ibrutinib，Lenalidomide, Rituximab）in Untreated and Unfit Elderly Patients With Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 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, open-label phase 2 study of iR2 in the treatment of unfit and elderly patients with untreated diffuse large B-cell lymphoma。
详细描述
This open-label, single arm study will evaluate the efficacy and safety of ibrutinib， lenalidomide, rituximab (iR2) in previously untreated and unfit elderly subjects with diffuse large B-cell lymphoma. Subjects will receive 6 cycles of ibrutinib 560mg, day 1-21, orally (PO) , lenalidomide 25mg, day 1-10, rituximab 375mg/m2, intravenously, every 21 days.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed diffuse large B cell lymphoma, treatment naive
- •Age > 75 years
- •Ineligible for standard chemotherapy
- •Must has measurable lesion in CT or PET-CT prior to treatment
- •At least 3 months life expectation
- •Informed consented
- •No previous use of study drug
排除标准
- •Has accepted Chemotherapy before
- •Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- •Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/L ;Platelet<80*10^9/L; ALT or AST >2*ULN; AKP or bilirubin >1.5*ULN ;Creatinine>1.5*ULN
- •Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation
- •HIV infection
- •If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
- •Other uncontrollable medical condition that may that may interfere the participation of the study
研究组 & 干预措施
iR2
Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).
干预措施: Ibrutinib (Drug)
iR2
Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).
干预措施: Lenalidomide (Drug)
iR2
Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).
干预措施: Rituximab (Drug)
结局指标
主要结局
Complete response rate
时间窗: At the end of Cycle 6 (each cycle is 21 days)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
次要结局
- Overall response rate(At the end of Cycle 6 (each cycle is 21 days))
- Progression free survival(Baseline up to data cut-off (up to approximately 4 years))
- Overall survival(Baseline up to data cut-off (up to approximately 4 years))
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Baseline up to data cut-off (up to approximately 4 years))
研究者
Zhao Weili
First Deputy Director，Hematology Department
Ruijin Hospital