Clinical trial NCT04982471: Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
Official title: Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
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®
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Patient characteristics
timeFrame: Up to 5 years
measure: Diagnostic and Treatment Patterns - Treatment Sequencing
timeFrame: Up to 5 years
measure: Progression-free Survival (PFS)
timeFrame: Up to 5 years
measure: Event-free Survival (EFS)
timeFrame: Up to 5 years
measure: Overall Response Rate (ORR)
timeFrame: Up to 5 years
measure: Time to Next Treatment (TTNT)
timeFrame: Up to 5 years
measure: Overall Survival (OS)
timeFrame: Up to 5 years
measure: Practice patterns
timeFrame: Up to 5 years
measure: Therapeutic strategies
timeFrame: Up to 5 years
measure: Diagnostic and Treatment Patterns - Changing Treatment Landscape
timeFrame: Up to 5 years
measure: Diagnostic and Treatment Patterns - Factors Associated with Treatment Choice
timeFrame: Up to 5 years
Secondary outcomes:
measure: Safety Outcomes
timeFrame: Up to 5 years
measure: Healthcare Resource Utilization (HCRU)
timeFrame: Up to 5 years
measure: Patient Reported Outcomes
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Hot Springs
country: United States
facility: Local Institution - 105
state: Arkansas
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers (Boulder) - USOR
state: Colorado
city: Pensacola
country: United States
facility: Woodlands Medical Specialists, PA
state: Florida
city: Pensacola
country: United States
facility: Local Institution - 169
state: Florida
city: Winter Haven
country: United States
facility: Bond Clinic, P.A.
state: Florida
city: Winter Haven
country: United States
facility: Local Institution - 121
state: Florida
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
city: Savannah
country: United States
facility: Local Institution - 112
state: Georgia
city: Savannah
country: United States
facility: Summit Cancer Care, PC
state: Georgia
city: Urbana
country: United States
facility: Local Institution - 127
state: Illinois
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research, Hematology and Oncology
state: Kansas
city: Topeka
country: United States
facility: Local Institution - 133
state: Kansas
city: Lewiston
country: United States
facility: Local Institution - 134
state: Maine
city: Bethesda
country: United States
facility: Local Institution - 106
state: Maryland
city: Bethesda
country: United States
facility: Regional Cancer Care Associates
state: Maryland
city: Chevy Chase
country: United States
facility: Local Institution - 139
state: Maryland
city: Cumberland
country: United States
facility: Local Institution - 101
state: Maryland
city: Cumberland
country: United States
facility: UPMC Western Maryland Corporation
state: Maryland
city: Hyannis
country: United States
facility: Local Institution - 130
state: Massachusetts
city: Saint Louis Park
country: United States
facility: Local Institution - 110
state: Minnesota
city: Saint Louis Park
country: United States
facility: Oncology Research, HealthPartners Institute
state: Minnesota
city: Joplin
country: United States
facility: Local Institution - 119
state: Missouri
city: Lincoln
country: United States
facility: Local Institution - 108
state: Nebraska
city: Reno
country: United States
facility: Local Institution - 162
state: Nevada
city: Belleville
country: United States
facility: New Jersey Cancer Care
state: New Jersey
city: East Brunswick
country: United States
facility: Astera Cancer Care East Brunswick
state: New Jersey
city: Florham Park
country: United States
facility: Local Institution - 132
state: New Jersey
city: Freehold
country: United States
facility: Local Institution - 140
state: New Jersey
city: Howell
country: United States
facility: Local Institution - 141
state: New Jersey
city: Little Silver
country: United States
facility: Local Institution - 138
state: New Jersey
city: Kinston
country: United States
facility: Local Institution - 128
state: North Carolina
city: Canton
country: United States
facility: Local Institution - 111
state: Ohio
city: Canton
country: United States
facility: Tri County Hematology Oncology
state: Ohio
city: North Canton
country: United States
facility: Local Institution - 113
state: Ohio
city: Springfield
country: United States
facility: Local Institution - 156
state: Oregon
city: Bethlehem
country: United States
facility: Local Institution - 149
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 170
state: Pennsylvania
city: West Reading
country: United States
facility: Local Institution - 171
state: Pennsylvania
city: York
country: United States
facility: Cancer Care Associates of York
state: Pennsylvania
city: York
country: United States
facility: Local Institution - 117
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Oncology, P.A
state: South Carolina
city: Charleston
country: United States
facility: Local Institution - 109
state: South Carolina
city: Knoxville
country: United States
facility: Local Institution - 118
state: Tennessee
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Fort Sam Houston
country: United States
facility: Local Institution - 125
state: Texas
city: Houston
country: United States
facility: Local Institution - 102
state: Texas
city: The Woodlands
country: United States
facility: Local Institution - 103
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical (Millennium Physicians Woodlands)
state: Texas
city: Tacoma
country: United States
facility: Local Institution - 115
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research and Innovation
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties PLLC
state: Washington
city: Green Bay
country: United States
facility: Local Institution - 122
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: