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Trial record 1 of 1 for:    NCT04982471
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Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study

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ClinicalTrials.gov Identifier: NCT04982471
Recruitment Status : Recruiting
First Posted : July 29, 2021
Last Update Posted : November 16, 2022
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease
Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular Lymphoma, B-Cell

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), R/R follicular lymphoma (FL), and primary mediastinal B-cell lymphoma (PMBCL). 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
Actual Study Start Date : November 5, 2021
Estimated Primary Completion Date : July 30, 2029
Estimated Study Completion Date : July 30, 2029


Group/Cohort
First relapsed/refractory diffuse large B-cell lymphoma
First relapsed/refractory diffuse large B-cell lymphoma (DLBCL) participants who have initiated second-line (2L) systemic treatment within 60 days prior to enrollment (date of informed consent)
Second relapsed/refractory diffuse large B-cell lymphoma
Second relapsed/refractory diffuse large B-cell lymphoma (DLBCL) participants who have initiated third-line (3L) systemic treatment within 60 days prior to enrollment
First relapsed/refractory follicular lymphoma
First relapsed/refractory follicular lymphoma (FL) participants who have initiated 2L systemic treatment within 60 days prior to enrollment
First relapsed/refractory primary mediastinal B-cell lymphoma
First relapsed/refractory primary mediastinal B-cell lymphoma (PMBCL) participants who initiated 2L systemic treatment within 60 days prior to enrollment



Primary Outcome Measures :
  1. Patient characteristics [ Time Frame: Up to 5 years ]
    Describe patient characteristics in community and academic settings

  2. Diagnostic and Treatment Patterns - Treatment Sequencing [ Time Frame: Up to 5 years ]
    Describes treatment sequencing

  3. Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]
    Evaluate the effectiveness of various treatments on progression-free survival (PFS)

  4. Event-free Survival (EFS) [ Time Frame: Up to 5 years ]
    Evaluate the effectiveness of various treatments on event free survival (EFS)

  5. Overall Response Rate (ORR) [ Time Frame: Up to 5 years ]
    Evaluate the effectiveness of various treatments on the overall response rate (ORR)

  6. Time to Next Treatment (TTNT) [ Time Frame: Up to 5 years ]
    Evaluate the effectiveness of various treatments on time to next treatment (TTNT)

  7. Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Evaluate the effectiveness of various treatments on Overall Survival (OS)

  8. Practice patterns [ Time Frame: Up to 5 years ]
    Describe practice patterns in community and academic settings

  9. Therapeutic strategies [ Time Frame: Up to 5 years ]
    Describe therapeutic strategies in community and academic settings

  10. Diagnostic and Treatment Patterns - Changing Treatment Landscape [ Time Frame: Up to 5 years ]
    Describes changing treatment landscape over time

  11. 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


Secondary Outcome Measures :
  1. Safety Outcomes [ Time Frame: Up to 5 years ]
    Describe safety outcomes associated with treatment regimens (adverse events of interest [AEIs]and SAEs)

  2. 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)

  3. 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)


Biospecimen Retention:   Samples With DNA
Collect, store, and test tumor biopsies, blood, plasma, DNA and RNA samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive participants with confirmed relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or primary mediastinal B-cell lymphoma (PMBCL) will be screened for eligibility and enrolled from approximately 200 sites in the United States, consisting mainly of community oncology sites (~80%) and academic sites (~20%) throughout the United States. A total of approximately 2,100 participants will be enrolled over an estimated 3-year period in the Registry into 1 of the 4 predefined cohorts listed above.
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)
    • Primary mediastinal B-cell lymphoma (PMBCL)
  • 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 and must have initiated 2L systemic treatment ≤ 60 days prior to enrollment
  • For second R/R DLBCL cohort, participant must have confirmed second R/R disease during or after 2L systemic treatment and must have initiated 3L systemic treatment ≤ 60 days prior to 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04982471


Contacts
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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 #.

Locations
Show Show 40 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04982471    
Other Study ID Numbers: NDS-DLBCL-003
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: November 16, 2022
Last Verified: November 2022
Individual Participant Data (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/


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Non-Hodgkin Lymphoma (NHL)
Diffuse large B-Cell lymphoma (DLBCL)
Follicular lymphoma (FL)
Primary mediastinal B-Cell lymphoma (PMBCL)
Registry
Connect®
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases