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

NCT ID: NCT04982471

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-03
• Study Completion Date: 2023-08-03

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).

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), 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

First relapsed/refractory diffuse large B-cell lymphoma

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

No interventions assigned to this group

First relapsed/refractory follicular lymphoma

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Genesis Cancer Center

Hot Springs, Arkansas, United States

Local Institution - 105

Hot Springs, Arkansas, United States

Rocky Mountain Cancer Centers (Boulder) - USOR

Boulder, Colorado, United States

Woodlands Medical Specialists, PA

Pensacola, Florida, United States

Local Institution - 169

Pensacola, Florida, United States

Bond Clinic, P.A.

Winter Haven, Florida, United States

Local Institution - 121

Winter Haven, Florida, United States

Harbin Clinic

Rome, Georgia, United States

Local Institution - 112

Savannah, Georgia, United States

Summit Cancer Care, PC

Savannah, Georgia, United States

Local Institution - 127

Urbana, Illinois, United States

Cotton O'Neil Clinical Research, Hematology and Oncology

Topeka, Kansas, United States

Local Institution - 133

Topeka, Kansas, United States

Local Institution - 134

Lewiston, Maine, United States

Local Institution - 106

Bethesda, Maryland, United States

Regional Cancer Care Associates

Bethesda, Maryland, United States

Local Institution - 139

Chevy Chase, Maryland, United States

Local Institution - 101

Cumberland, Maryland, United States

UPMC Western Maryland Corporation

Cumberland, Maryland, United States

Local Institution - 130

Hyannis, Massachusetts, United States

Local Institution - 110

Saint Louis Park, Minnesota, United States

Oncology Research, HealthPartners Institute

Saint Louis Park, Minnesota, United States

Local Institution - 119

Joplin, Missouri, United States

Local Institution - 108

Lincoln, Nebraska, United States

Local Institution - 162

Reno, Nevada, United States

New Jersey Cancer Care

Belleville, New Jersey, United States

Astera Cancer Care East Brunswick

East Brunswick, New Jersey, United States

Local Institution - 132

Florham Park, New Jersey, United States

Local Institution - 140

Freehold, New Jersey, United States

Local Institution - 141

Howell Township, New Jersey, United States

Local Institution - 138

Little Silver, New Jersey, United States

Local Institution - 128

Kinston, North Carolina, United States

Local Institution - 111

Canton, Ohio, United States

Tri County Hematology Oncology

Canton, Ohio, United States

Local Institution - 113

North Canton, Ohio, United States

Local Institution - 156

Springfield, Oregon, United States

Local Institution - 149

Bethlehem, Pennsylvania, United States

Local Institution - 170

Philadelphia, Pennsylvania, United States

Local Institution - 171

West Reading, Pennsylvania, United States

Cancer Care Associates of York

York, Pennsylvania, United States

Local Institution - 117

York, Pennsylvania, United States

Charleston Oncology, P.A

Charleston, South Carolina, United States

Local Institution - 109

Charleston, South Carolina, United States

Local Institution - 118

Knoxville, Tennessee, United States

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Local Institution - 125

Fort Sam Houston, Texas, United States

Local Institution - 102

Houston, Texas, United States

Local Institution - 103

The Woodlands, Texas, United States

Renovatio Clinical (Millennium Physicians Woodlands)

The Woodlands, Texas, 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

Local Institution - 122

Green Bay, Wisconsin, United States

Countries

United States

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

Other Identifiers

NDS-DLBCL-003

Identifier Type: -

Identifier Source: org_study_id