NCT05338892已完成不适用
Outcomes in Patients With Relapse/Refractory Diffuse Large B-Cell Lymphoma Treated With Systemic Therapy From Real-World Experience (ORCHID)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 595
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Primary Objective:
To evaluate objective response rate (ORR) in adult patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma (Cheson, 2014) and as assessed by independent central review
Secondary Objectives:
To evaluate the following outcomes in adult patients with r/r DLBCL who are treated with currently available therapies in the real-world setting:
- ORR according to Lugano classification and as assessed by treating physician evaluation
- Complete Response (CR) rate according to Lugano classification and as assessed by:
- Independent central review, and
- Treating physician evaluation
- Progression Free Survival (PFS) according to Lugano classification and as assessed by:
- Independent central review, and
- Treating physician evaluation
- Overall Survival (OS)
- Duration of response (DOR) according to Lugano classification and as assessed by
- Independent central review and
- Treating physician evaluation
- Disease control rate (DCR) according to Lugano classification and as assessed by:
- Independent central reviewed
- Treating physician evaluation
- Time to next treatment (TTNT)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a histologically confirmed diagnosis of DLBCL on or after 01 Jan 2010 as defined in the protocol
- •Have been r/r to at least 2 lines of systemic therapy for DLBCL, including an anti-CD20 antibody and an alkylating agent as defined in the protocol
- •Have initiated at least one additional line (3L+) of systemic therapy (salvage therapy) for DLBCL between 01 Jan 2015 and 30 Jun 2021 (indexing period) after meeting the criteria for r/r DLBCL as described above; the first additional line of systemic therapy during the indexing period that meets all of the remaining inclusion and exclusion criteria defined below will be the patients' first qualifying salvage therapy.
- •Have measurable disease on cross sectional imaging (defined as at least 1 bi-dimensionally measurable nodal lesion ≥1.5 centimeter [cm] in the greatest transverse diameter [GTD] regardless of the short axis diameter) documented by diagnostic imaging (computed tomography [CT], or magnetic resonance imaging [MRI]) recorded on or during the 8 weeks prior to index date
- •Have been seen at a site that routinely assesses DLBCL treatment response according to Lugano classification of malignant lymphoma (ie, sites with ≥50% DLBCL patients with treatment response according to Lugano classification)
- •Have DLBCL treatment response assessed according to Lugano classification of malignant lymphoma or are deceased prior to opportunity for assessment
排除标准
- •Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS non-Hodgkin's lymphoma (NHL) on or prior to index date
- •History of allo-stem cell transplant (SCT) prior to index date
- •Treatment with any chimeric antigen receptor T (CAR-T) therapy prior to index date
- •Received anti-CD20 x anti-CD3 bispecific therapy prior to index date
- •History of neurodegenerative condition or CNS movement disorder on or prior to index date
- •Evidence of significant cardiovascular disease on or prior to index date
- •Evidence of significant pulmonary disease, defined as obstructive pulmonary disease and a history of symptomatic bronchospasm on or prior to index date
- •Eastern Cooperative Oncology Group (ECOG) performance status >1 on or prior to index date
- •Inadequate organ function as defined in the protocol
- •Note: Other protocol-defined Inclusion/Exclusion criteria apply
结局指标
主要结局
Objective response rate
时间窗: Up to 84 months
The proportion of best overall response of complete response (CR) or partial response (PR).
次要结局
- Time to Next Treatment (TTNT)(Up to 84 months)
- Complete Response (CR) rate(Up to 84 months)
- Progression Free Survival (PFS)(Up to 84 months)
- Disease Control Rate (DCR)(Up to 84 months)
- Overall Survival (OS)(Up to 84 months)
- Duration of Response (DOR)(Up to 84 months)
研究者
研究点 (1)
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