ctDNA-Guided Mosunetuzumab Consolidation Therapy in Older Patients With Untreated DLBCL
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ctDNA clearance rate after mosunetuzumab treatment
研究概览
简要总结
Older patients with diffuse large B- cell lymphoma (DLBCL) do not have the same rates of disease control as younger patients and are at risk for toxicity. Identifying which patients might benefit from more therapy at the end of first-line treatment is important. The ability to measure small amounts of persistent lymphoma (circulating tumor DNA or ctDNA) might allow the investigators to risk stratify patients. If older patients have detectable ctDNA in the blood at the end of six cycles of polatuzumab vedotin, rituximab and dose-attentuated CHP chemotherapy, patients will receive a bispecific antibody called mosunetuzumab. The investigators hypothesize this will result in "clearing" the ctDNA from the blood and result in better disease control and outcomes for patients. The study will also measure the safety of this regimen and the impact on the function of these older patients utilizing a tool called the geriatric assessment.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ctDNA positive
Patients who have achieved a radiographic complete response (CR) on PET/CT, but have detectable ctDNA at the end of treatment with pola-R-mini-CHP will receive 6 cycles of mosunetuzumab consolidation. Patients who have achieved a CR with undetectable ctDNA will be observed. Patients with a partial response on PET/CT will be managed per protocol.
干预措施: Mosunetuzumab (Drug)
ctDNA positive
Patients who have achieved a radiographic complete response (CR) on PET/CT, but have detectable ctDNA at the end of treatment with pola-R-mini-CHP will receive 6 cycles of mosunetuzumab consolidation. Patients who have achieved a CR with undetectable ctDNA will be observed. Patients with a partial response on PET/CT will be managed per protocol.
干预措施: ClonoSEQ (Device)
结局指标
主要结局
ctDNA clearance rate after mosunetuzumab treatment
时间窗: From the beginning to the end of mosunetuzumab treatment at 18 weeks
The primary endpoint of the trial is the ctDNA clearance rate after mosunetuzumab treatment among the subset of patients in a PET/CT CR but with ctDNA+ at the end of 6 cycles of R-pola-mini-CHP. The rate will be calculated as the number of subjects ctDNA- after mosunetuzumab treatment among all patients treated with mosunetuzumab as part of the Fleming two-stage design.
次要结局
- Objective response rate and complete response rate of pola-R-mini-CHP(From enrollment to the end of pola-R-mini-CHP treatment at 18 weeks)
研究者
Danielle Wallace
Assistant Professor
University of Rochester