A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 plus Rituximab versus Chemotherapy plus Rituximab in Previously Untreated Participants with Follicular Lymphoma (SOUNDTRACK-F1)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- 1.SRI primary: Safety evaluation of Surovatamig in combination with Rituximab
研究概览
简要总结
Safety Run in:
1.To assess the safety and tolerability of Surovatamig plus rituximab (R) in participants with previously untreated FL 2.To determine the recommended Phase III dose (RP3D)
Phase 3:
- To demonstrate the superiority of Surovatamig plus R compared to Investigator’s choice of SoC chemoimmunotherapy by assessment of PFS and End of Induction (EoI) Objective Response Rate (ORR)
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase III
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •1.Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
- •2.Histologically confirmed diagnosis of classic FL per WHO 2022 classification
- •Stage II to IV and FLIPI 2 to 5 (Ph3)
- •4.ECOG performance status of 0 to 2
- •5.Previously untreated FL requiring systemic treatment by meeting at least 1 GELF criteria
- •6.FDG-avid and measurable disease
- •Adequate liver, hematological, renal and cardiac function.
排除标准
- •1.Follicular large B-cell lymphoma (WHO 2022 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
- •2.Contraindication to any of the individual components of B-R, R-CVP, or R-CHOP regimens, or contraindication to Surovatamig
- •3.Participants with or history of CNS lymphoma
- •4.Presence of >5000 circulating lymphoma cells
- •5.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
1.SRI primary: Safety evaluation of Surovatamig in combination with Rituximab
1.SRI primary: Safety evaluation of Surovatamig in combination with Rituximab
2.SRI Primary: Determination of the recommended Phase III dose (RP3D)
2.SRI Primary: Determination of the recommended Phase III dose (RP3D)
3.Phase 3 Primary: To demonstrate the superiority of clinical efficacy of Surovatamig+R compared to SOC chemoimmunotherapy in participants with untreated FL
3.Phase 3 Primary: To demonstrate the superiority of clinical efficacy of Surovatamig+R compared to SOC chemoimmunotherapy in participants with untreated FL
次要结局
- Phase 3: CR rate at 30 months
- Phase 3: TFST
- Phase 3: PFS2
- Safety Run in and Phase 3: ORR
- Safety Run In and Phase 3: CR Rate
- Safety Run In and Phase 3: CR at EoI
- Safety Run In and Phase 3: DoR
- Safety Run In and Phase 3: PFS
- Safety Run In and Phase 3: OS
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB