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Lymphoma, Non-HodgkinNCT04982471

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

An observational study of Lymphoma, Non-Hodgkin and Lymphoma, Large B-Cell, Diffuse, run by Celgene at 53 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
How many people
36 participants
Where
53 sitesUnited States
Study dates
3 Nov 2021to 3 Aug 2023
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

United States53 sites

  • New Jersey Cancer Care

    Belleville, New Jersey, 07109

  • Local Institution - 106

    Bethesda, Maryland, 20817

  • Regional Cancer Care Associates

    Bethesda, Maryland, 20817

  • Local Institution - 149

    Bethlehem, Pennsylvania, 18015

  • Rocky Mountain Cancer Centers (Boulder) - USOR

    Boulder, Colorado, 80303

  • Local Institution - 111

    Canton, Ohio, 44718

  • Tri County Hematology Oncology

    Canton, Ohio, 44718

  • Charleston Oncology, P.A

    Charleston, South Carolina, 29414

  • Local Institution - 109

    Charleston, South Carolina, 29414

  • Local Institution - 139

    Chevy Chase, Maryland, 20815

  • Local Institution - 101

    Cumberland, Maryland, 21502

  • UPMC Western Maryland Corporation

    Cumberland, Maryland, 21502

  • Astera Cancer Care East Brunswick

    East Brunswick, New Jersey, 08816

  • Local Institution - 132

    Florham Park, New Jersey, 07932

  • Local Institution - 125

    Fort Sam Houston, Texas, 78234

  • Local Institution - 140

    Freehold, New Jersey, 07728

  • Local Institution - 122

    Green Bay, Wisconsin, 54301

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Local Institution - 105

    Hot Springs, Arkansas, 71913

  • Local Institution - 102

    Houston, Texas, 77003

  • Local Institution - 141

    Howell Township, New Jersey, 07731

  • Local Institution - 130

    Hyannis, Massachusetts, 02601

  • Local Institution - 119

    Joplin, Missouri, 64804

  • Local Institution - 128

    Kinston, North Carolina, 28501

  • Local Institution - 118

    Knoxville, Tennessee, 37916

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Local Institution - 134

    Lewiston, Maine, 04240

  • Local Institution - 108

    Lincoln, Nebraska, 68510-2496

  • Local Institution - 138

    Little Silver, New Jersey, 07739

  • Local Institution - 113

    North Canton, Ohio, 44708

  • Woodlands Medical Specialists, PA

    Pensacola, Florida, 32503

  • Local Institution - 169

    Pensacola, Florida, 32504

  • Local Institution - 170

    Philadelphia, Pennsylvania, 19066

  • Local Institution - 162

    Reno, Nevada, 89511

  • Harbin Clinic

    Rome, Georgia, 30165

  • Local Institution - 110

    Saint Louis Park, Minnesota, 55416

  • Oncology Research, HealthPartners Institute

    Saint Louis Park, Minnesota, 55426

  • Local Institution - 112

    Savannah, Georgia, 31401

  • Summit Cancer Care, PC

    Savannah, Georgia, 31401

  • Local Institution - 156

    Springfield, Oregon, 97477

  • Local Institution - 115

    Tacoma, Washington, 98402

  • MultiCare Institute for Research and Innovation

    Tacoma, Washington, 98405

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405

  • Local Institution - 103

    The Woodlands, Texas, 77380

  • Renovatio Clinical (Millennium Physicians Woodlands)

    The Woodlands, Texas, 77389

  • Cotton O'Neil Clinical Research, Hematology and Oncology

    Topeka, Kansas, 66606

  • Local Institution - 133

    Topeka, Kansas, 66606

  • Local Institution - 127

    Urbana, Illinois, 61801

  • Local Institution - 171

    West Reading, Pennsylvania, 19611

  • Bond Clinic, P.A.

    Winter Haven, Florida, 33881

  • Local Institution - 121

    Winter Haven, Florida, 33881

  • Cancer Care Associates of York

    York, Pennsylvania, 17403

  • Local Institution - 117

    York, Pennsylvania, 17403

Other trials in United States

About this 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).

Read the 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.

Keywords
Non-Hodgkin Lymphoma (NHL), Diffuse large B-Cell lymphoma (DLBCL), Follicular lymphoma (FL), Registry, Connect®
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04982471
Study groupRoleWhat they receive
First relapsed/refractory diffuse large B-cell lymphomaFirst 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 lymphomaFirst 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient characteristics

    Describe patient characteristics in community and academic settings

    Measured: Up to 5 years

  2. Diagnostic and Treatment Patterns - Treatment Sequencing

    Describes treatment sequencing

    Measured: Up to 5 years

  3. Progression-free Survival (PFS)

    Evaluate the effectiveness of various treatments on progression-free survival (PFS)

    Measured: Up to 5 years

  4. Event-free Survival (EFS)

    Evaluate the effectiveness of various treatments on event free survival (EFS)

    Measured: Up to 5 years

  5. Overall Response Rate (ORR)

    Evaluate the effectiveness of various treatments on the overall response rate (ORR)

    Measured: Up to 5 years

  6. Time to Next Treatment (TTNT)

    Evaluate the effectiveness of various treatments on time to next treatment (TTNT)

    Measured: Up to 5 years

  7. Overall Survival (OS)

    Evaluate the effectiveness of various treatments on Overall Survival (OS)

    Measured: Up to 5 years

  8. Practice patterns

    Describe practice patterns in community and academic settings

    Measured: Up to 5 years

  9. Therapeutic strategies

    Describe therapeutic strategies in community and academic settings

    Measured: Up to 5 years

  10. Diagnostic and Treatment Patterns - Changing Treatment Landscape

    Describes changing treatment landscape over time

    Measured: Up to 5 years

  11. 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

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Safety Outcomes

    Describe safety outcomes associated with treatment regimens (adverse events of interest [AEIs]and SAEs)

    Measured: Up to 5 years

  2. 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)

    Measured: Up to 5 years

  3. 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)

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2021
  2. Study start3 Nov 2021
  3. Primary completion3 Aug 2023
  4. Study completion3 Aug 2023

Why it stopped: Slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
36 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04982471
Sponsor's protocol ID
NDS-DLBCL-003
Status last verified
Mar 2025
First submitted
20 Jul 2021
Last updated
11 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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/

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphoma, Non-Hodgkin and Lymphoma, Large B-Cell, Diffuse, run by Celgene at 53 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Slow accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient characteristics (time frame: Up to 5 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04982471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.

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