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 18, 2023
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Condition or disease |
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Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular |
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 |
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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
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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
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- 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
- 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)
Biospecimen Retention: Samples With DNA
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.
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 |
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
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Must have 1 of the following histologically confirmed Non-Hodgkin Lymphoma (NHL) subtypes:
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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)
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- 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
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
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 #. |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
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 18, 2023 |
Last Verified: | November 2023 |
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/ |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Non-Hodgkin Lymphoma (NHL) Diffuse large B-Cell lymphoma (DLBCL) Follicular lymphoma (FL) Registry Connect® |
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell |