Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
- Conditions
- Lymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, Diffuse
- Registration Number
- NCT04982471
- Lead Sponsor
- Celgene
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 36
-
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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) Up to 5 years Evaluate the effectiveness of various treatments on the overall response rate (ORR)
Patient characteristics Up to 5 years Describe patient characteristics in community and academic settings
Diagnostic and Treatment Patterns - Treatment Sequencing Up to 5 years Describes treatment sequencing
Progression-free Survival (PFS) Up to 5 years Evaluate the effectiveness of various treatments on progression-free survival (PFS)
Event-free Survival (EFS) Up to 5 years Evaluate the effectiveness of various treatments on event free survival (EFS)
Time to Next Treatment (TTNT) Up to 5 years Evaluate the effectiveness of various treatments on time to next treatment (TTNT)
Diagnostic and Treatment Patterns - Factors Associated with Treatment Choice Up to 5 years Describes factors associated with treatment choice, including CAR T-cell and non-CAR T-cell therapies
Overall Survival (OS) Up to 5 years Evaluate the effectiveness of various treatments on Overall Survival (OS)
Practice patterns Up to 5 years Describe practice patterns in community and academic settings
Therapeutic strategies Up to 5 years Describe therapeutic strategies in community and academic settings
Diagnostic and Treatment Patterns - Changing Treatment Landscape Up to 5 years Describes changing treatment landscape over time
- Secondary Outcome Measures
Name Time Method Safety Outcomes Up to 5 years Describe safety outcomes associated with treatment regimens (adverse events of interest \[AEIs\]and SAEs)
Healthcare Resource Utilization (HCRU) Up to 5 years Describe patient-reported HRQoL outcomes among the overall cohort population and among patient subgroups of interest (e.g.,age, risk, treatment regimen, disease subtype)
Patient Reported Outcomes Up to 5 years 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)
Trial Locations
- Locations (53)
Local Institution - 133
🇺🇸Topeka, Kansas, United States
Local Institution - 139
🇺🇸Chevy Chase, Maryland, United States
Local Institution - 141
🇺🇸Howell, New Jersey, United States
Local Institution - 138
🇺🇸Little Silver, New Jersey, United States
Local Institution - 149
🇺🇸Bethlehem, Pennsylvania, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Local Institution - 105
🇺🇸Hot Springs, Arkansas, United States
Woodlands Medical Specialists, PA
🇺🇸Pensacola, Florida, United States
Harbin Clinic
🇺🇸Rome, Georgia, United States
Rocky Mountain Cancer Centers (Boulder) - USOR
🇺🇸Boulder, Colorado, United States
Local Institution - 169
🇺🇸Pensacola, Florida, United States
Summit Cancer Care, PC
🇺🇸Savannah, Georgia, United States
New Jersey Cancer Care
🇺🇸Belleville, New Jersey, United States
Bond Clinic, P.A.
🇺🇸Winter Haven, Florida, United States
Local Institution - 121
🇺🇸Winter Haven, Florida, United States
Local Institution - 112
🇺🇸Savannah, Georgia, United States
Local Institution - 106
🇺🇸Bethesda, Maryland, United States
Local Institution - 127
🇺🇸Urbana, Illinois, United States
Cotton O'Neil Clinical Research, Hematology and Oncology
🇺🇸Topeka, Kansas, United States
Local Institution - 134
🇺🇸Lewiston, Maine, United States
Regional Cancer Care Associates
🇺🇸Bethesda, Maryland, United States
Local Institution - 101
🇺🇸Cumberland, Maryland, United States
Local Institution - 110
🇺🇸Saint Louis Park, Minnesota, United States
UPMC Western Maryland Corporation
🇺🇸Cumberland, Maryland, United States
Local Institution - 130
🇺🇸Hyannis, Massachusetts, 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
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 - 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 - 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