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

ABSTRACT

Introduction: Non-Hodgkin lymphoma (NHL) constitutes ~40% of hematologic malignancies and, in 2020, resulted in 19,940 deaths in the USA. The most common NHL subtypes are diffuse large B-cell lymphoma (DLBCL), including primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma (FL). Although a majority of patients respond to standard-of-care therapy, many patients with NHL eventually relapse, highlighting the need for additional treatments. Real-world data regarding the safety and efficacy of emerging therapies in the relapsed/refractory (R/R) population, and the association between treatment patterns and patient outcomes, are limited. These data could provide unique insights to clinical and health-related quality of life (HRQoL) outcomes in patients with DLBCL, FL, or PMBCL treated with emerging therapies, especially novel options such as chimeric antigen receptor (CAR) T cell therapies. Methods: The Connect ® Lymphoma Disease Registry (NCT04982471) is a US-based, multicenter, prospective observational cohort study of patients with R/R NHL (DLBCL, FL, and PMBCL). Approximately 2100 patients ≥ 18 years of age from ~200 community oncology (~80%) or academic (~20%) sites will be enrolled over a ~3-year period. Patients with histologically confirmed NHL subtypes will be enrolled into 1 of 4 cohorts first R/R DLBCL, second R/R DLBCL, first R/R FL, or first R/R PMBCL (Figure). Patients will be required to have begun second- (first R/R) or third- (second R/R) line systemic treatment within 60 days prior to enrollment. Patients receiving treatment for any active malignancy other than DLBCL, FL, or PMBCL at the time of enrollment, or who are diagnosed with any other malignancy in the 6 months prior to enrollment, will be excluded. All treatment and management decisions will be determined by the practicing clinicians. Patients may undergo hematopoietic stem cell transplantation, CAR T cell therapy, or other treatments at other sites while participating in this study. Patients will be followed from enrollment for up to 5 years or until death, withdrawal of consent, loss to follow-up, or study termination, whichever occurs first. Data collection will occur at enrollment (baseline) and then every ~3 months. The main objectives of the Connect ® Registry are to describe patient characteristics, practice patterns, and factors associated with treatment choice, sequencing, and effectiveness in NHL subtypes. Secondary objectives include describing treatment regimen safety, patient-reported outcomes (PROs) including HRQoL, and healthcare resource utilization outcomes. Exploratory objectives include tumor and blood biomarker evaluation and understanding the availability of social support and its impact on long-term treatment decision-making. Case report forms will be used to collect clinical and treatment data, including baseline demographics, clinical characteristics, treatment details and response, and socioeconomic factors. Outcome measures for efficacy will be progression-free survival, event-free survival, objective response rate, time to next treatment, and overall survival. The availability of social support will be assessed via a specific questionnaire administered at baseline. General (EQ-5D-5L) and disease-specific (FACT-Lym) questionnaires will also be administered. Patients may also optionally agree to release tumor biopsies and blood samples for biomarker analysis. Clinicians will be required to report serious adverse events (AEs), secondary primary malignancies, and confirmed COVID-19 infections within 24 hours. Non-serious AEs of interest include grade 1-3 cytokine release syndrome, grade 1-3 neurotoxicity, grade 3 colitis, grade 3 arrhythmia, grade 3 hemorrhage. Other AEs of interest to be collected include grade 3 hypogammaglobulinemia, prolonged grade 3 cytopenia, and grade 3 infections. Data collected in the Connect ® Registry will increase understanding of the association between emerging therapies and patient outcomes for R/R DLBCL, FL, and PMBCL. Study support Bristol Myers Squibb [Formula presented] Disclosures Flowers Amgen Research Funding;Janssen Research Funding;Biopharma Consultancy;Ziopharm Research Funding;Burroughs Wellcome Fund Research Funding;Nektar Research Funding;Karyopharm Consultancy;Iovance Research Funding;Allogene Research Funding;AbbVie Consultancy, Research Funding;Cellectis Research Funding;Pfizer Research Funding;Sanofi Research Funding;BeiGene Consultancy;Kite Research Funding;EMD Research Funding;Genentech/Roche Consultancy, Research Funding;Morphosys Research Funding;Adaptimmune Research Funding;Novartis Research Funding;Epizyme, Inc. Consultancy;Spectrum Consultancy;Pharmacyclics/Janssen Consultancy;Acerta Research Funding;4D Research Funding;Denovo Consultancy;Celgene Consultancy, Research Funding;Guardant Research Funding;Genmab Consultancy;Gilead Consultancy, Research Funding;Bayer Consultancy, Research Funding;SeaGen Consultancy;Cancer Prevention and Research Institute of Texas CPRIT Scholar in Cancer Research Research Funding;Takeda Research Funding;National Cancer Institute Research Funding;TG Therapeutics Research Funding;Eastern Cooperative Oncology Group Research Funding;Xencor Research Funding;Pharmacyclics Research Funding. Andorsky Celgene/Bristol Myers Squibb Research Funding;AbbVie Consultancy;Celgene/Bristol Myers Squibb Consultancy;AstraZeneca Other served on steering committees;Epizyme Research Funding;AbbVie Research Funding. Burke SeaGen Consultancy, Speakers Bureau;X4 Pharmaceuticals Consultancy;Bristol Myers Squibb Consultancy;Verastem Consultancy;AstraZeneca Consultancy;MorphoSys Consultancy;Adaptive Biotechnologies Consultancy;Roche/Genentech Consultancy;Epizyme Consultancy;Kura Consultancy;AbbVie Consultancy;Beigene Consultancy, Speakers Bureau;Kymera Consultancy. Cerhan Genentech Research Funding;NanoString Research Funding;Celgene/BMS Other Connect Lymphoma Scientific Steering Committee, Research Funding;Regeneron Genetics Center Other Research Collaboration. Grinblatt Astellas Pharma, Inc. Consultancy;Bristol Myers Squibb Consultancy;Astra Zeneca Consultancy;AbbVie Consultancy. Toomey Bristol Myers Squibb Consultancy. Zelenetz Gilead Honoraria, Research Funding;Verastem Honoraria;Novartis Honoraria;MEI Pharma Honoraria, Research Funding;SecuraBio Honoraria;Abbvie Honoraria, Research Funding;MorphoSys Honoraria;Pharmacyclics Honoraria;AstraZeneca Honoraria;LFR Other;Genentech/Roche Honoraria, Research Funding;NCCN Other;MethylGene Research Funding;Beigene Honoraria, Other, Research Funding;BMS/Celgene/JUNO Honoraria, Other;Amgen Honoraria;Gilead Honoraria;Janssen Honoraria. Sullivan Bristol Myers Squibb Current Employment, Current holder of individual stocks in a privately-held company. Flick Bristol Myers Squibb Current Employment. Kiselev Bristol Myers Squibb Current Employment, Current equity holder in publicly-traded company, Current holder of individual stocks in a privately-held company. Kaplan Bristol Myers Squibb Current Employment. Ahn Bristol Myers Squibb Current Employment.