Realmind: A Prospective, Multicenter, Observational Study of Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Starting Second- or Third-Line Therapy and Not Receiving Autologous Stem Cell Transplant

Background

While >60% of patients with diffuse large B-cell lymphoma (DLBCL) are cured when treated with R-CHOP after initial diagnosis, ~40% will be refractory or relapse (R/R) after achieving a response with first-line therapy. Until recently, patients with R/R disease have been treated with rituximab + chemotherapy combinations, rituximab + lenalidomide and salvage chemotherapy followed by high-dose chemotherapy and autologous stem cell transplant (ASCT). Additional FDA-approved treatment options, recently introduced, include the CD19-directed cytolytic antibody tafasitamab in combination with lenalidomide (granted accelerated approval) for second-line or later patients, as well as CAR T-cell therapies, the CD79b-directed antibody-drug conjugate polatuzumab combined with bendamustine + rituximab, and the CD19-directed antibody-drug conjugate loncastuximab for third-line or later patients. Sequencing these various options and identifying the optimal choice of treatment for individual patients can be challenging for practicing oncologists. The realMIND study (NCT04981795), will assess treatment patterns, physician-reported clinical outcomes and patient-reported health-related quality of life (HRQoL) among patients with R/R DLBCL not eligible for ASCT, and is designed to produce data to support physician decision-making in individualized, patient-centric care. realMIND also has a special focus on patients belonging to racial and ethnic minority groups, different age groups, and those with different socio-economic statuses to ensure strong representation among the US patient population.

Study design and methods

realMIND is a Phase IV, multicenter, prospective, observational study in which an estimated 1,000 patients will be enrolled from ~75 sites in the US. Enrollment will aim to achieve a representative distribution of adult patients by age, gender, race and ethnicity by actively seeking sites from a broad range of locations, including otherwise under-represented populations. Eligible patients will be aged ≥18 years with histologically confirmed DLBCL at initial diagnosis (including high-grade double- and triple-hit lymphoma), and R/R status after at least one prior systemic therapy and prior to second- or third-line therapy for DLBCL (Figure 1). Patients currently receiving ASCT (but not those with prior ASCT experience) will be excluded. Physician-validated clinical outcomes will include complete response rate, overall response rate, duration of response, event-free survival and overall survival. Safety will be evaluated by assessing serious adverse events (AEs) and AEs leading to treatment discontinuation, interruption or dose modification, as well as AEs in patients treated with tafasitamab. Pathology assessments such as biomarker status (e.g. antigen expression on tumor cells) will be identified using clinical samples taken at initial diagnosis and relapse. Patient-reported outcomes will include general and lymphoma-specific measures of HRQoL (EORTC QLQ-C30 and FACT-Lym), collected as part of usual care visits at least quarterly during follow-up. The end of the study is expected to occur approximately 79 months after the first patient is enrolled to ensure a minimum of 24 months' follow-up after last patient enrollment. The distribution of patient characteristics and all survival outcome measures will be presented using descriptive statistics; time-to-event analyses will be conducted using Kaplan-Meier methods.

Summary

realMIND is a large-scale, multicenter, real-world study that aims to describe the treatment patterns and clinical outcomes of patients with R/R DLBCL. The study is currently enrolling with a planned sample size of 1,000 patients from ~75 sites in the US. The study population will aim to enroll a representative distribution of patients within the US, facilitating an investigation of outcomes in a patient population reflecting real-world clinical practice.

Funding: MorphoSys AG.

Figure 1

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Figure 1

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