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

• ClinicalTrials.gov Identifier: NCT04982471
• Recruitment Status: Recruiting
• First Posted: July 29, 2021
• Last Update Posted: November 18, 2023
• Sponsor: Celgene
• Information provided by (Responsible Party): Celgene

Tracking Information

• First Submitted Date: July 20, 2021
• First Posted Date: July 29, 2021
• Last Update Posted Date: November 18, 2023
• Actual Study Start Date: November 5, 2021
• Estimated Primary Completion Date: July 30, 2029 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 20, 2021)

• Patient characteristics [ Time Frame: Up to 5 years ]
  Describe patient characteristics in community and academic settings
• Diagnostic and Treatment Patterns - Treatment Sequencing [ Time Frame: Up to 5 years ]
  Describes treatment sequencing
• Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]
  Evaluate the effectiveness of various treatments on progression-free survival (PFS)
• Event-free Survival (EFS) [ Time Frame: Up to 5 years ]
  Evaluate the effectiveness of various treatments on event free survival (EFS)
• Overall Response Rate (ORR) [ Time Frame: Up to 5 years ]
  Evaluate the effectiveness of various treatments on the overall response rate (ORR)
• Time to Next Treatment (TTNT) [ Time Frame: Up to 5 years ]
  Evaluate the effectiveness of various treatments on time to next treatment (TTNT)
• Overall Survival (OS) [ Time Frame: Up to 5 years ]
  Evaluate the effectiveness of various treatments on Overall Survival (OS)
• Practice patterns [ Time Frame: Up to 5 years ]
  Describe practice patterns in community and academic settings
• Therapeutic strategies [ Time Frame: Up to 5 years ]
  Describe therapeutic strategies in community and academic settings
• Diagnostic and Treatment Patterns - Changing Treatment Landscape [ Time Frame: Up to 5 years ]
  Describes changing treatment landscape over time
• Diagnostic and Treatment Patterns - Factors Associated with Treatment Choice [ Time Frame: Up to 5 years ]
  Describes factors associated with treatment choice, including CAR T-cell and non-CAR T-cell therapies

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 20, 2021)

• Safety Outcomes [ Time Frame: Up to 5 years ]
  Describe safety outcomes associated with treatment regimens (adverse events of interest [AEIs]and SAEs)
• Healthcare Resource Utilization (HCRU) [ Time Frame: 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 [ Time Frame: 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
• Official Title: Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
• 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.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years

Biospecimen

Retention:   Samples With DNA

Description:

Collect, store, and test tumor biopsies, blood, plasma, DNA and RNA samples

• 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.

Condition

• Lymphoma, Non-Hodgkin
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Follicular

• Intervention: Not Provided

Study Groups/Cohorts

• First relapsed/refractory diffuse large B-cell lymphoma
  First 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 lymphoma
  First 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 6, 2022): 1000
• Original Estimated Enrollment (submitted: July 20, 2021): 2100
• Estimated Study Completion Date: July 30, 2029
• Estimated Primary Completion Date: July 30, 2029 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com; 855-907-3286; Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04982471
• Other Study ID Numbers: NDS-DLBCL-003
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

Plan Description

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/

• Current Responsible Party: Celgene
• Original Responsible Party: Same as current
• Current Study Sponsor: Celgene
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Celgene
• Verification Date: November 2023