Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 36
- 试验地点
- 53
- 主要终点
- Patient characteristics
研究概览
简要总结
The Connect® Lymphoma Disease Registry is a US-based, multicenter, prospective observational (non-interventional) cohort study designed to collect real-world, participant-level data longitudinally in participants diagnosed with various subtypes of non-Hodgkin lymphoma (NHL).
详细描述
This Disease Registry is designed to capture the patient characteristics, practice patterns, and therapeutic strategies evaluated in community and academic centers when treating relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), and R/R follicular lymphoma (FL). The data collected in this Registry will facilitate the evaluation of the current treatment landscape for non-Hodgkin lymphoma (NHL), including the clinical effectiveness, safety. No investigational product or drug will be administered as part of this study. Enrolled patients will receive treatment and evaluations for their disease according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for their disease will be recorded, including any previous lymphoma treatments. Clinical outcomes will be documented as part of an objective clinical assessment. In addition, patient-reported health-related quality of life (HRQoL) outcomes data will be collected from patients using various validated instruments. Social support data will also be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Must be ≥18 years of age at the time of consent
- •Must be able to provide written informed consent personally or by legally authorized representative
- •Must have 1 of the following histologically confirmed Non-Hodgkin Lymphoma (NHL) subtypes:
- •Diffuse large B-cell lymphoma (DLBCL), NOS; or DLBCL high-grade lymphoma, not otherwise specified (NOS); or DLBCL high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma)
- •Epstein-Barr virus-positive or composite DLBCL are allowed
- •Follicular lymphoma (FL)
- •Must have been previously treated with ≥ 1 prior systemic therapy (e.g., chemotherapy, immunotherapy, or chemoimmunotherapy)
- •For first relapsed/refractory (R/R) DLBCL cohort, participant must have confirmed R/R disease within 90 days prior to study enrollment and must intend to initiate 2L systemic treatment
- •For first R/R FL cohort, participant must have confirmed R/R disease (grade 1 to 3B or transformed) within 90 days prior to study enrollment and must intend to initiate 2L systemic treatment
- •Participant must be willing and able to complete enrollment and follow-up health-related quality of life (HRQoL) and social support instruments
- •Participants volunteering for the Tissue Sub-Study must consent for use of their blood/tumor biopsies, which were collected as per standard of care, for exploratory analyses
排除标准
- •Participant whose prior start and end date of DLBCL or FL treatment, and prior treatment received, including chemotherapy, radiation, surgery (not including excisional biopsies), and other anticancer therapy, are unknown
- •Participant who has any other active malignancy (non-DLBCL or non-FL) for which the participant is receiving treatment at the time of enrollment or any other former malignancy that was diagnosed within 6 months prior to Registry enrollment (with the exception of non-melanoma skin cancer)
- •Currently enrolled in any interventional clinical trial where the participant is being treated with an investigational product that cannot be identified
结局指标
主要结局
Patient characteristics
时间窗: Up to 5 years
Describe patient characteristics in community and academic settings
Diagnostic and Treatment Patterns - Treatment Sequencing
时间窗: Up to 5 years
Describes treatment sequencing
Progression-free Survival (PFS)
时间窗: Up to 5 years
Evaluate the effectiveness of various treatments on progression-free survival (PFS)
Event-free Survival (EFS)
时间窗: Up to 5 years
Evaluate the effectiveness of various treatments on event free survival (EFS)
Time to Next Treatment (TTNT)
时间窗: Up to 5 years
Evaluate the effectiveness of various treatments on time to next treatment (TTNT)
Diagnostic and Treatment Patterns - Factors Associated with Treatment Choice
时间窗: Up to 5 years
Describes factors associated with treatment choice, including CAR T-cell and non-CAR T-cell therapies
Overall Response Rate (ORR)
时间窗: Up to 5 years
Evaluate the effectiveness of various treatments on the overall response rate (ORR)
Overall Survival (OS)
时间窗: Up to 5 years
Evaluate the effectiveness of various treatments on Overall Survival (OS)
Practice patterns
时间窗: Up to 5 years
Describe practice patterns in community and academic settings
Therapeutic strategies
时间窗: Up to 5 years
Describe therapeutic strategies in community and academic settings
Diagnostic and Treatment Patterns - Changing Treatment Landscape
时间窗: Up to 5 years
Describes changing treatment landscape over time
次要结局
- Safety Outcomes(Up to 5 years)
- Healthcare Resource Utilization (HCRU)(Up to 5 years)
- Patient Reported Outcomes(Up to 5 years)