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

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).

Study Overview

• Status: Terminated
• Conditions: Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer Center
    • Hot Springs, Arkansas, United States, 71913
      • Local Institution - 105
  • Colorado
    • Boulder, Colorado, United States, 80303
      • Rocky Mountain Cancer Centers (Boulder) - USOR
  • Florida
    • Pensacola, Florida, United States, 32503
      • Woodlands Medical Specialists, PA
    • Pensacola, Florida, United States, 32504
      • Local Institution - 169
    • Winter Haven, Florida, United States, 33881
      • Bond Clinic, P.A.
    • Winter Haven, Florida, United States, 33881
      • Local Institution - 121
  • Georgia
    • Rome, Georgia, United States, 30165
      • Harbin Clinic
    • Savannah, Georgia, United States, 31401
      • Local Institution - 112
    • Savannah, Georgia, United States, 31401
      • Summit Cancer Care, PC
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Local Institution - 127
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinical Research, Hematology and Oncology
    • Topeka, Kansas, United States, 66606
      • Local Institution - 133
  • Maine
    • Lewiston, Maine, United States, 04240
      • Local Institution - 134
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Regional Cancer Care Associates
    • Bethesda, Maryland, United States, 20817
      • Local Institution - 106
    • Chevy Chase, Maryland, United States, 20815
      • Local Institution - 139
    • Cumberland, Maryland, United States, 21502
      • Local Institution - 101
    • Cumberland, Maryland, United States, 21502
      • UPMC Western Maryland Corporation
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601
      • Local Institution - 130
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Local Institution - 110
    • Saint Louis Park, Minnesota, United States, 55426
      • Oncology Research, HealthPartners Institute
  • Missouri
    • Joplin, Missouri, United States, 64804
      • Local Institution - 119
  • Nebraska
    • Lincoln, Nebraska, United States, 68510-2496
      • Local Institution - 108
  • Nevada
    • Reno, Nevada, United States, 89511
      • Local Institution - 162
  • New Jersey
    • Belleville, New Jersey, United States, 07109
      • New Jersey Cancer Care
    • East Brunswick, New Jersey, United States, 08816
      • Astera Cancer Care East Brunswick
    • Florham Park, New Jersey, United States, 07932
      • Local Institution - 132
    • Freehold, New Jersey, United States, 07728
      • Local Institution - 140
    • Howell, New Jersey, United States, 07731
      • Local Institution - 141
    • Little Silver, New Jersey, United States, 07739
      • Local Institution - 138
  • North Carolina
    • Kinston, North Carolina, United States, 28501
      • Local Institution - 128
  • Ohio
    • Canton, Ohio, United States, 44718
      • Local Institution - 111
    • Canton, Ohio, United States, 44718
      • Tri County Hematology Oncology
    • North Canton, Ohio, United States, 44708
      • Local Institution - 113
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Local Institution - 156
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Local Institution - 149
    • Philadelphia, Pennsylvania, United States, 19066
      • Local Institution - 170
    • West Reading, Pennsylvania, United States, 19611
      • Local Institution - 171
    • York, Pennsylvania, United States, 17403
      • Cancer Care Associates of York
    • York, Pennsylvania, United States, 17403
      • Local Institution - 117
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Oncology, P.A
    • Charleston, South Carolina, United States, 29414
      • Local Institution - 109
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Center
    • Knoxville, Tennessee, United States, 37916
      • Local Institution - 118
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Local Institution - 125
    • Houston, Texas, United States, 77003
      • Local Institution - 102
    • The Woodlands, Texas, United States, 77380
      • Local Institution - 103
    • The Woodlands, Texas, United States, 77389
      • Renovatio Clinical (Millennium Physicians Woodlands)
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties PLLC
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research and Innovation
    • Tacoma, Washington, United States, 98402
      • Local Institution - 115
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Local Institution - 122

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): August 3, 2023
• Study Completion (Actual): August 3, 2023

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Non-Hodgkin Lymphoma (NHL); Diffuse large B-Cell lymphoma (DLBCL); Follicular lymphoma (FL); Registry; Connect®
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, B-Cell; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, Follicular
• Other Study ID Numbers: NDS-DLBCL-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No