Non Hodgkin Lymphoma Clinical Trial
Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
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).
Full 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
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There are 47 Locations for this study
Hot Springs Arkansas, 71913, United States
Fresno California, 93703, United States More Info
Monterey California, 93940, United States
Jacksonville Florida, 32209, United States More Info
Jacksonville Florida, 32256, United States
Pensacola Florida, 32503, United States
Winter Haven Florida, 33881, United States
Savannah Georgia, 31401, United States
Topeka Kansas, 66606, United States
Topeka Kansas, 66606, United States More Info
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Lewiston Maine, 04240, United States
Bethesda Maryland, 20817, United States
Cumberland Maryland, 21502, United States
Cumberland Maryland, 21502, United States More Info
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Ann Arbor Michigan, 48109, United States More Info
Minneapolis Minnesota, 55455, United States
Saint Louis Park Minnesota, 55426, United States
Saint Louis Park Minnesota, 55426, United States More Info
Columbia Missouri, 65201, United States More Info
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Reno Nevada, 89511, United States
East Brunswick New Jersey, 08816, United States More Info
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Little Silver New Jersey, 07739, United States More Info
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Morristown New Jersey, 07960, United States
Rochester New York, 14621, United States
Valhalla New York, 10595, United States
Canton Ohio, 44718, United States
Philadelphia Pennsylvania, 19066, United States More Info
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Philadelphia Pennsylvania, 19111, United States
York Pennsylvania, 17403, United States
York Pennsylvania, 17403, United States More Info
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Charleston South Carolina, 29414, United States
Knoxville Tennessee, 37916, United States
Houston Texas, 77003, United States More Info
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The Woodlands Texas, 77380, United States More Info
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The Woodlands Texas, 77389, United States
Tyler Texas, 75702, United States
Tacoma Washington, 98405, United States
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