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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982471
• Other study ID #: NDS-DLBCL-003
• Status: Recruiting
• Start date: November 5, 2021
• Est. completion date: July 30, 2029

Study information

• Verified date: November 2023
• Source: Celgene
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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), 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 30, 2029
• Est. primary completion date: July 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University Of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	New Jersey Cancer Care	Belleville	New Jersey
United States	Local Institution - 106	Bethesda	Maryland
United States	Regional Cancer Care Associates	Bethesda	Maryland
United States	Rocky Mountain Cancer Centers (Boulder) - USOR	Boulder	Colorado
United States	Local Institution - 111	Canton	Ohio
United States	Local Institution - 113	Canton	Ohio
United States	Tri County Hematology Oncology	Canton	Ohio
United States	Charleston Oncology, P.A	Charleston	South Carolina
United States	Local Institution - 109	Charleston	South Carolina
United States	Harry S. Truman Memorial Veterans' Hospital (HSTMVH) - NAVREF - PPDS	Columbia	Missouri
United States	Local Institution - 101	Cumberland	Maryland
United States	UPMC Western Maryland Corporation	Cumberland	Maryland
United States	Astera Cancer Care East Brunswick	East Brunswick	New Jersey
United States	Local Institution - 132	Florham Park	New Jersey
United States	Local Institution - 125	Fort Sam Houston	Texas
United States	Compassionate Cancer Care Medical Group	Fountain Valley	California
United States	Local Institution - 140	Freehold	New Jersey
United States	VA Central California Health Care System - NAVREF - PPDS	Fresno	California
United States	Local Institution - 122	Green Bay	Wisconsin
United States	East Carolina University	Greenville	North Carolina
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	Local Institution - 105	Hot Springs	Arkansas
United States	Local Institution - 102	Houston	Texas
United States	Regional Cancer Care Associates (Howell )	Howell	New Jersey
United States	Local Institution - 130	Hyannis	Massachusetts
United States	Cancer Specialists Of North Florida	Jacksonville	Florida
United States	University of Florida College of Medicine Jacksonville	Jacksonville	Florida
United States	Local Institution - 119	Joplin	Missouri
United States	Local Institution - 128	Kinston	North Carolina
United States	Local Institution - 118	Knoxville	Tennessee
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Local Institution - 134	Lewiston	Maine
United States	Local Institution - 108	Lincoln	Nebraska
United States	RCCA - Little Silver Division	Little Silver	New Jersey
United States	University Of Minnesota	Minneapolis	Minnesota
United States	Pacific Cancer Care	Monterey	California
United States	Atlantic Hematology Oncology - Morristown	Morristown	New Jersey
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Local Institution - 169	Pensacola	Florida
United States	Sacred Heart Medical Oncology	Pensacola	Florida
United States	Woodlands Medical Specialists, PA	Pensacola	Florida
United States	Woodlands Medical Specialists, Pa	Pensacola	Florida
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Local Institution - 170	Philadelphia	Pennsylvania
United States	Desert Hematology Oncology Medical Group	Rancho Mirage	California
United States	Local Institution - 162	Reno	Nevada
United States	Rochester General Hospital - Lipson Cancer Institute	Rochester	New York
United States	Harbin Clinic	Rome	Georgia
United States	Saint Louis University	Saint Louis	Missouri
United States	Local Institution - 110	Saint Louis Park	Minnesota
United States	Oncology Research, HealthPartners Institute	Saint Louis Park	Minnesota
United States	Local Institution - 112	Savannah	Georgia
United States	Summit Cancer Care, PC	Savannah	Georgia
United States	Benaroya Research Institute At Virginia Mason	Seattle	Washington
United States	Local Institution - 156	Springfield	Oregon
United States	Local Institution - 115	Tacoma	Washington
United States	MultiCare Institute for Research and Innovation	Tacoma	Washington
United States	Northwest Medical Specialties PLLC	Tacoma	Washington
United States	Northwest Medical Specialties PLLC	Tacoma	Washington
United States	Local Institution - 103	The Woodlands	Texas
United States	Renovatio Clinical (Millennium Physicians Woodlands)	The Woodlands	Texas
United States	Cotton O'Neil Clinical Research, Hematology and Oncology	Topeka	Kansas
United States	Cotton O'Neil Clinical Research, Hematology and Oncology	Topeka	Kansas
United States	Texas Oncology, P.A. - Tyler	Tyler	Texas
United States	Local Institution - 127	Urbana	Illinois
United States	New York Medical College	Valhalla	New York
United States	Local Institution - 171	West Reading	Pennsylvania
United States	Bond Clinic, P.A.	Winter Haven	Florida
United States	Local Institution - 121	Winter Haven	Florida
United States	Cancer Care Associates of York	York	Pennsylvania
United States	Local Institution - 117	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient characteristics	Describe patient characteristics in community and academic settings	Up to 5 years
Primary	Diagnostic and Treatment Patterns - Treatment Sequencing	Describes treatment sequencing	Up to 5 years
Primary	Progression-free Survival (PFS)	Evaluate the effectiveness of various treatments on progression-free survival (PFS)	Up to 5 years
Primary	Event-free Survival (EFS)	Evaluate the effectiveness of various treatments on event free survival (EFS)	Up to 5 years
Primary	Overall Response Rate (ORR)	Evaluate the effectiveness of various treatments on the overall response rate (ORR)	Up to 5 years
Primary	Time to Next Treatment (TTNT)	Evaluate the effectiveness of various treatments on time to next treatment (TTNT)	Up to 5 years
Primary	Overall Survival (OS)	Evaluate the effectiveness of various treatments on Overall Survival (OS)	Up to 5 years
Primary	Practice patterns	Describe practice patterns in community and academic settings	Up to 5 years
Primary	Therapeutic strategies	Describe therapeutic strategies in community and academic settings	Up to 5 years
Primary	Diagnostic and Treatment Patterns - Changing Treatment Landscape	Describes changing treatment landscape over time	Up to 5 years
Primary	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	Safety Outcomes	Describe safety outcomes associated with treatment regimens (adverse events of interest [AEIs]and SAEs)	Up to 5 years
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls