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

NCT04982471 | Terminated

• 1 other identifier: NDS-DLBCL-003
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 53

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).

Conditions

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

Keywords

Non-Hodgkin Lymphoma (NHL); Diffuse large B-Cell lymphoma (DLBCL); Follicular lymphoma (FL); Registry; Connect®

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (3)

• Safety Outcomes

  Up to 5 years

• Healthcare Resource Utilization (HCRU)

  Up to 5 years

• Patient Reported Outcomes

  Up to 5 years

Study Arms (2)

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive participants with confirmed relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) will be screened for eligibility and enrolled from approximately 100 sites in the United States, consisting mainly of community oncology sites (\~80%) and academic sites (\~20%) throughout the United States. A total of approximately 1000 participants will be enrolled over an estimated 3-year period in the Registry into 1 of the 2 predefined cohorts listed above.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (53)

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

Local Institution - 105

Hot Springs, Arkansas, 71913, United States

Location

Rocky Mountain Cancer Centers (Boulder) - USOR

Boulder, Colorado, 80303, United States

Location

Woodlands Medical Specialists, PA

Pensacola, Florida, 32503, United States

Location

Local Institution - 169

Pensacola, Florida, 32504, United States

Location

Bond Clinic, P.A.

Winter Haven, Florida, 33881, United States

Location

Local Institution - 121

Winter Haven, Florida, 33881, United States

Location

Harbin Clinic

Rome, Georgia, 30165, United States

Location

Local Institution - 112

Savannah, Georgia, 31401, United States

Location

Summit Cancer Care, PC

Savannah, Georgia, 31401, United States

Location

Local Institution - 127

Urbana, Illinois, 61801, United States

Location

Cotton O'Neil Clinical Research, Hematology and Oncology

Topeka, Kansas, 66606, United States

Location

Local Institution - 133

Topeka, Kansas, 66606, United States

Location

Local Institution - 134

Lewiston, Maine, 04240, United States

Location

Local Institution - 106

Bethesda, Maryland, 20817, United States

Location

Regional Cancer Care Associates

Bethesda, Maryland, 20817, United States

Location

Local Institution - 139

Chevy Chase, Maryland, 20815, United States

Location

Local Institution - 101

Cumberland, Maryland, 21502, United States

Location

UPMC Western Maryland Corporation

Cumberland, Maryland, 21502, United States

Location

Local Institution - 130

Hyannis, Massachusetts, 02601, United States

Location

Local Institution - 110

Saint Louis Park, Minnesota, 55416, United States

Location

Oncology Research, HealthPartners Institute

Saint Louis Park, Minnesota, 55426, United States

Location

Local Institution - 119

Joplin, Missouri, 64804, United States

Location

Local Institution - 108

Lincoln, Nebraska, 68510-2496, United States

Location

Local Institution - 162

Reno, Nevada, 89511, United States

Location

New Jersey Cancer Care

Belleville, New Jersey, 07109, United States

Location

Astera Cancer Care East Brunswick

East Brunswick, New Jersey, 08816, United States

Location

Local Institution - 132

Florham Park, New Jersey, 07932, United States

Location

Local Institution - 140

Freehold, New Jersey, 07728, United States

Location

Local Institution - 141

Howell Township, New Jersey, 07731, United States

Location

Local Institution - 138

Little Silver, New Jersey, 07739, United States

Location

Local Institution - 128

Kinston, North Carolina, 28501, United States

Location

Local Institution - 111

Canton, Ohio, 44718, United States

Location

Tri County Hematology Oncology

Canton, Ohio, 44718, United States

Location

Local Institution - 113

North Canton, Ohio, 44708, United States

Location

Local Institution - 156

Springfield, Oregon, 97477, United States

Location

Local Institution - 149

Bethlehem, Pennsylvania, 18015, United States

Location

Local Institution - 170

Philadelphia, Pennsylvania, 19066, United States

Location

Local Institution - 171

West Reading, Pennsylvania, 19611, United States

Location

Cancer Care Associates of York

York, Pennsylvania, 17403, United States

Location

Local Institution - 117

York, Pennsylvania, 17403, United States

Location

Charleston Oncology, P.A

Charleston, South Carolina, 29414, United States

Location

Local Institution - 109

Charleston, South Carolina, 29414, United States

Location

Local Institution - 118

Knoxville, Tennessee, 37916, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Local Institution - 125

Fort Sam Houston, Texas, 78234, United States

Location

Local Institution - 102

Houston, Texas, 77003, United States

Location

Local Institution - 103

The Woodlands, Texas, 77380, United States

Location

Renovatio Clinical (Millennium Physicians Woodlands)

The Woodlands, Texas, 77389, United States

Location

Local Institution - 115

Tacoma, Washington, 98402, United States

Location

MultiCare Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Northwest Medical Specialties PLLC

Tacoma, Washington, 98405, United States

Location

Local Institution - 122

Green Bay, Wisconsin, 54301, United States

Location

Related Links

• BMS Clinical Trial Information

Biospecimen

Retention: SAMPLES WITH DNA

Collect, store, and test tumor biopsies, blood, plasma, DNA and RNA samples

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 29, 2021
• Study Start: November 3, 2021
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (53)