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

Sponsor

Celgene (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04982471

Collaborator

(none)

2,100

Enrollment

Locations

92.9

Anticipated Duration (Months)

161.5

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular Lymphoma, B-Cell

Detailed Description

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), R/R follicular lymphoma (FL), and primary mediastinal B-cell lymphoma (PMBCL). 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 3, 2021

Anticipated Primary Completion Date :

Jul 31, 2029

Anticipated Study Completion Date :

Jul 31, 2029

Arms and Interventions

Arm	Intervention/Treatment
First relapsed/refractory diffuse large B-cell lymphoma First relapsed/refractory diffuse large B-cell lymphoma (DLBCL) participants who have initiated second-line (2L) systemic treatment within 60 days prior to enrollment (date of informed consent)
Second relapsed/refractory diffuse large B-cell lymphoma Second relapsed/refractory diffuse large B-cell lymphoma (DLBCL) participants who have initiated third-line (3L) systemic treatment within 60 days prior to enrollment
First relapsed/refractory follicular lymphoma First relapsed/refractory follicular lymphoma (FL) participants who have initiated 2L systemic treatment within 60 days prior to enrollment
First relapsed/refractory primary mediastinal B-cell lymphoma First relapsed/refractory primary mediastinal B-cell lymphoma (PMBCL) participants who initiated 2L systemic treatment within 60 days prior to enrollment

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)
Primary mediastinal B-cell lymphoma (PMBCL)
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 and must have initiated 2L systemic treatment ≤ 60 days prior to enrollment
For second R/R DLBCL cohort, participant must have confirmed second R/R disease during or after 2L systemic treatment and must have initiated 3L systemic treatment ≤ 60 days prior to enrollment
For first R/R FL cohort, participant must have confirmed R/R disease (grade 1 to 3B or transformed) and must have initiated 2L systemic treatment ≤ 60 days prior to enrollment
For first R/R PMBCL cohort, participant must have confirmed first R/R disease during or after 1L systemic treatment and must have initiated 2L systemic treatment ≤ 60 days prior to enrollment
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, FL, or PMBCL 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, non-PMBCL, 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Genesis Cancer Center	Hot Springs	Arkansas	United States	71913
2	Bond Clinic, P.A.	Winter Haven	Florida	United States	33881
3	Summit Cancer Care, PC	Savannah	Georgia	United States	31401
4	Cotton O'Neil Clinical Research, Hematology and Oncology	Topeka	Kansas	United States	66606
5	Regional Cancer Care Associates	Bethesda	Maryland	United States	20817
6	UPMC Western Maryland Corporation	Cumberland	Maryland	United States	21502
7	Oncology Research, HealthPartners Institute	Saint Louis Park	Minnesota	United States	55426
8	Tri County Hematology Oncology	Canton	Ohio	United States	44718
9	Cancer Care Associates of York	York	Pennsylvania	United States	17403
10	Charleston Oncology, P.A	Charleston	South Carolina	United States	29414
11	Thompson Cancer Survival Center	Knoxville	Tennessee	United States	37916
12	Renovatio Clinical (Millennium Physicians Woodlands)	The Woodlands	Texas	United States	77389
13	MultiCare Institute for Research and Innovation	Tacoma	Washington	United States	98405