ABCL-051 realMIND: A Prospective, Multicenter, Observational Study of Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Starting Second/Third-Line Therapy and Not Receiving a Stem Cell Transplant

Christopher R. Flowers, John M. Burke, Mirko Vukcevic, Susan Snodgrass, Kim Saverno, Mary Ann A. Lumiqued, Haifaa Abdulhaq, Elizabeth Brem, Andrew Evens, Umar Farooq, Pierluigi Porcu, Mazyar Shadman

Research output: Contribution to journalArticlepeer-review

Abstract

Context: Up to 40% of patients with diffuse large B-cell lymphoma (DLBCL) will have relapsed/refractory (R/R) disease after first-line (1L) treatment with R-CHOP. Treatment options for autologous stem cell transplant (ASCT)-ineligible patients with R/R DLBCL include the chemo-free immunotherapy tafasitamab + lenalidomide, polatuzumab + bendamustine + rituximab, loncastuximab tesirine, selinexor, and CD19 chimeric antigen receptor (CAR) T-cell therapies. Treatment sequencing and identifying the optimal choice for individual patients can be challenging for oncologists. Objective: realMIND (NCT04981795) will assess real-world treatment patterns, effectiveness measures, and patient-reported outcomes among patients in the United States (US) with R/R DLBCL not receiving ASCT. Design: A Phase IV, prospective, multicenter, observational study enrolling a diverse patient population with R/R DLBCL regarding age, ethnicity, and race. Expected enrollment is ~1000 patients with completion expected ~79 months after the first patient is enrolled. Setting: Actively recruiting in ~75 US community and academic centers. Patients: Eligible and aged ≥18 years with histologically confirmed R/R DLBCL after ≥1 systemic therapy, including ASCT. Interventions: Patients may enroll (a) after completing 1L therapy and before starting second-line (2L) therapy, (b) within 30 days after starting 2L therapy, or (c) after completing 2L and before receiving third-line therapy. Patient history data on therapies received before study enrollment will be collected from patient records; data generated from the time of enrollment onwards will be collected prospectively. Main Outcome Measures: Real-world effectiveness measures include complete and objective response rate, duration of response, event-free survival, and overall survival; safety endpoints include serious adverse events and adverse events leading to treatment discontinuation, interruption, or dose modification. Patient-reported outcomes include general and lymphoma-specific measures of health-related quality of life assessed by the EORTC Quality of Life Questionnaire-Core 30 and Functional Assessment of Cancer Therapy – Lymphoma, and work productivity by the Work Productivity and Activity Impairment Questionnaire. Results: Not yet available. Conclusions: realMIND will characterize the R/R DLBCL patient journey with respect to treatment patterns, clinical and patient-reported outcomes. The study population will reflect a representative patient distribution within the US, facilitating the investigation of outcomes reflecting real-world clinical practice and producing data to support healthcare decision-making.

Original languageEnglish (US)
Pages (from-to)S355-S356
JournalClinical Lymphoma, Myeloma and Leukemia
Volume22
DOIs
StatePublished - Oct 2022

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology
  • Cancer Research

Keywords

  • ABCL
  • CD19
  • DLBCL
  • lenalidomide
  • realMIND
  • tafasitamab
  • Trial-in-Progress

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