A Prospective Phase II Study of Polatuzumab, Rituximab, and Lenalidomide(Pola-R2) in Newly-diagnosed Non-fit Elderly DLBCL Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- complete remission rate
研究概览
简要总结
This is a prospective, single-arm, phase II study, and the purpose of this study is to evaluate the efficacy and safety of Pola-R2 regimen in newly diagnosed elderly diffuse large B cell lymphoma classified into un-fit or frail group by comprehensive geriatric assessment(CGA).
详细描述
In this prospective study, all the eligible patients will be given Pola-R2 regimen(polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days). An interim evaluation will be performed after 4 cycles, the patients who achieve CR or PR will receive another 4 cycles of Pola-R2.
The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient volunteered to participate in the study and signed the Informed Consent
- •Histopathologically confirmed DLBCL and treatment naive(corticosteroids alone is not considered as a line of treatment)
- •Age≥ 70 years old, and was un-fit or frail according to comprehensive geriatric assessment
- •Adequate organ function and adequate bone marrow reserve
排除标准
- •Coexisting malignancy other than lymphoma
- •Active HBV infection
- •Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
研究组 & 干预措施
Experimental arm
Pola-R2 regimen Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days
干预措施: Polatuzumab Vedotin, Rituximab, Lenalidomide (Drug)
结局指标
主要结局
complete remission rate
时间窗: evaluated every 3 months，up to 24 months
proportion of patients achieving complete remission
次要结局
- overall remission rate(evaluated every 3 months，up to 24 months)
- 2 year progression-free survival rate(2 years after last patient included)
- 2 year overall survival rate(2 years after last patient included)
- any adverse event occurred during this study(2 years after last patient included)
研究者
Yan Zhang, MD
associate director of department of hematology
Peking Union Medical College Hospital