Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study

Conditions
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Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First relapsed/refractory diffuse large B-cell lymphoma<br>First relapsed/refractory diffuse large B-cell lymphoma (DLBCL) participants must have been diagnosed with relapsed/refractory (R/R) disease within 90 days prior to study enrollment and must intend to initiate 2L systemic treatment | |
| First relapsed/refractory follicular lymphoma<br>First relapsed/refractory (R/R) follicular lymphoma (FL) participants must have been diagnosed with R/R disease (grade 1 to 3B or transformed) within 90 days prior to study enrollment and must intend to initiate 2L systemic treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient characteristics | Describe patient characteristics in community and academic settings | Up to 5 years | 
| Diagnostic and Treatment Patterns - Treatment Sequencing | Describes treatment sequencing | Up to 5 years | 
| Progression-free Survival (PFS) | Evaluate the effectiveness of various treatments on progression-free survival (PFS) | Up to 5 years | 
| Event-free Survival (EFS) | Evaluate the effectiveness of various treatments on event free survival (EFS) | Up to 5 years | 
| Overall Response Rate (ORR) | Evaluate the effectiveness of various treatments on the overall response rate (ORR) | Up to 5 years | 
| Time to Next Treatment (TTNT) | Evaluate the effectiveness of various treatments on time to next treatment (TTNT) | Up to 5 years | 
| Overall Survival (OS) | Evaluate the effectiveness of various treatments on Overall Survival (OS) | Up to 5 years | 
| Practice patterns | Describe practice patterns in community and academic settings | Up to 5 years | 
| Therapeutic strategies | Describe therapeutic strategies in community and academic settings | Up to 5 years | 
| Diagnostic and Treatment Patterns - Changing Treatment Landscape | Describes changing treatment landscape over time | Up to 5 years | 
| Diagnostic and Treatment Patterns - Factors Associated with Treatment Choice | Describes factors associated with treatment choice, including CAR T-cell and non-CAR T-cell therapies | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Outcomes | Describe safety outcomes associated with treatment regimens (adverse events of interest [AEIs]and SAEs) | Up to 5 years | 
| Healthcare Resource Utilization (HCRU) | Describe patient-reported HRQoL outcomes among the overall cohort population and among patient subgroups of interest (e.g.,age, risk, treatment regimen, disease subtype) | Up to 5 years | 
| Patient Reported Outcomes | Describe patient-reported health-related quality of life (HRQoL) outcomes among the overall cohort population and among patient subgroups of interest (e.g. age, risk, treatment regimen, disease subtype) | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Hodgkin Lymphoma (NHL), Diffuse large B-Cell lymphoma (DLBCL), Follicular lymphoma (FL), Registry, Connect®