An Exploratory Study to Correlate the Level of Cell-free DNA With Response to First-line Treatment in Patients With Follicular Lymphoma
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Follicular Lymphoma
- 发起方
- Memorial Sloan Kettering Cancer Center
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- whether the assay can correctly identify presence of disease in patients with measurable disease
- 状态
- 招募中
- 最后更新
- 8个月前
概览
简要总结
The researchers are doing this study to measure and test cell-free DNA (cfDNA) in the blood before, during, and after first-line treatment for follicular lymphoma. They will look at whether cfDNA levels are related to a person's response to the usual first-line treatment for follicular lymphoma. Researchers also want to understand how different genetic changes in follicular lymphoma relate to a person's response to the usual first-line treatment.
详细描述
This is a non-therapeutic protocol aimed to assess the ability of the s cfDNA assay to detect clinical response in FL when compared to conventional approaches for assessing response, such as PET-CT scans. Study assessments will include: 1) identification of the mutations present in the primary tumor, 2) identification of these mutations in the peripheral blood samples collected before initiation of standard therapy, after 2 cycles of therapy, at the completion of 6-8 cycles of induction therapy, and then every 6 months for a total of 2 years from the initiation of therapy using a cfDNA assay. For patients who receive RT, peripheral blood samples will be collected before initiation of RT, and then 3 months, 6 months, 12 months, 18 months and 24 months post RT using a s cfDNA assay.
研究者
入排标准
入选标准
- •≥18 years of age at time of signing informed consent. Consent is permitted from either the participant or from a Legally Authorized Representative (LAR) on their behalf.
- •Histology-confirmed follicular lymphoma grade 1-3a, verified by the enrolling institution
- •Ability to adhere to the study visit schedule and all the protocol requirements
- •Measurable FDG-avid disease
- •Not applicable for retrospective patients in CR
排除标准
- •Patients receiving second or greater line of therapy (except in retrospective cohort of long-term survivors of FL \[i.e. \>10 years out from frontline treatment\])
结局指标
主要结局
whether the assay can correctly identify presence of disease in patients with measurable disease
时间窗: 2 years
Response will be evaluated using the updated response criteria entitled, "The Lugano Classification" system. The investigator will use of the 5-point scale for visually assessing response on the pre- and end-of-treatment FDGPET/CT scans. This scale is commonly referred to as the Deauville criteria; it was developed by international experts in the field at the First International Workshop on interim-PET in Lymphoma in Deauville in 2009 and is routinely applied to patients undergoing lymphoma directed therapy. The 5-point scale is described in the table below. 1 No residual uptake 2 Uptake ≤ mediastinum 3 Uptake \> mediastinum but ≤ liver 4 Uptake moderately \> liver 5 Markedly increased uptake at any site or progression