Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
Principal Investigator: Dylan Zylla, MD
Study Sponsor: Celgene
Location: HealthPartners Frauenshuh Cancer Center, HealthPartners Cancer Center at Regions Hospital
Purpose of Study: This is an observational (non-interventional) study, meaning there is no drug or treatment being provided as part of the study. As the patient, you will receive standard of care and routine clinical practice, with the purpose of the study being to capture patient characteristics, practice patterns, and different treatment strategies when treating the following types of lymphoma; Relapsed/refractory (R/R), diffuse large B-cell lymphoma (DLBCL), R/R Follicular lymphoma (FL), and primary mediastinal b-cell lymphoma (PMBCL). Additionally, patient-reported health-related quality of life (HRQoL) outcomes will be collected from patients.
Inclusion Criteria:
- Must be ≥18 years of age at the time of consent
- 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, NOS, or DLBCL high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma)
(Epstien-Barr virus-positive or composite DLBCL are allowed)
Follicular lymphoma (FL)
Primary mediastinal B-cell lymphoma (PMBCL) - Must have been previously treated with at least 1 or more prior systemic therapy (i.e. chemotherapy, immunotherapy, chemoimmunotherapy)
- For first relapsed/refractory (R/R) DLBCL, participant must have confirmed second R/R disease during or after 2L systemic treatment and must have started 3L systemic treatment within 60 days prior to enrolling.
- For second R/R DLBCL cohort, participant must have confirmed second R/R disease or after 2L systemic treatment and must have started 3L treatment within 60 days of enrollment
- For first R/R FL cohort, participant must have confirmed R/R disease (grade 1 to 3B or transformed) and must have initiated 2L systemic treatment ≤ 60 days prior to enrollment
- For first R/R PMBCL cohort, participant must have confirmed first R/R disease during or after 1L systemic treatment and must have initiated 2L systemic treatment ≤ 60 days prior to enrollment
- 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.
- These criteria can further be discussed with the physician or study team.
Exclusion Criteria:
- Participant whose prior start and end date of DLBCL, FL, or PMBCL 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, non-PMBCL, 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 Contact:
Jordan Cowger
(952) 993-6071
Jordan.Cowger@parknicollet.com
