jRCT2031240501招募中不适用
This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the AZD0486 plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL. (SOUNDTRACK-F1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 109
- 主要终点
- Safety and tolerability of AZD0486 plus rituximab
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 130age old under（—）
- 性别
- All
入选标准
- •Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
- •Histologically confirmed diagnosis of FL Grades 1-3A per WHO 2016 classification
- •ECOG performance status of 0 to 2
- •No prior systemic lymphoma-directed therapy
- •Need for systemic treatment meeting at least 1 GELF criteria
- •FDG-avid and measurable disease
- •Adequate liver, hematological, renal and cardiac function.
- •The above is a summary, other inclusion criteria details may apply
排除标准
- •Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
- •Contra-indication to BR, RCVP, and R-CHOP
- •Participants with or history of CNS lymphoma
- •Presence of >5000 circulating lymphoma cells
- •Active or uncontrolled infection requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study
- •The above is a summary, other exclusion criteria details may apply
结局指标
主要结局
Safety and tolerability of AZD0486 plus rituximab
Incidence, nature, and severity of AEs and SAEs based on NCI CTCAE v5.0/ASTCT and changes in laboratory data and vital signs compared with baseline. Incidence and nature of study intervention discontinuations, dose reductions, and dose delays due to AEs.
Progression-free survival (PFS)
PFS is defined as time from date of randomisation until disease progression, or death due to any cause, whichever comes first, based on Lugano 2014 Response Criteria, as assessed by BICR.
次要结局
未报告次要终点
研究者
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