Clinical trial · Observational
Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
NCT04982471CI-TRIAL-00087029terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- First relapsed/refractory diffuse large B-cell lymphoma
- description
- 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
- label
- First relapsed/refractory follicular lymphoma
- description
- 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
Primary outcomes (11)
- measure
- Patient characteristics
- timeFrame
- Up to 5 years
- description
- Describe patient characteristics in community and academic settings
- measure
- Diagnostic and Treatment Patterns - Treatment Sequencing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 identifiedReferences
Publications (0)
Data not yet available
No reference posted for this study.