Journal article
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
Clinical lymphoma, myeloma and leukemia, Vol.22, pp.S355-S356
10/2022
DOI: 10.1016/S2152-2650(22)01494-X
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. Funding: MorphoSys AG
Details
- Title: Subtitle
- 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
- Creators
- Christopher R. Flowers - The University of Texas MD Anderson Cancer CenterJohn M. BurkeMirko VukcevicSusan SnodgrassKim SavernoMary Ann A. LumiquedHaifaa AbdulhaqElizabeth BremAndrew EvensUmar FarooqPierluigi PorcuMazyar Shadman
- Resource Type
- Journal article
- Publication Details
- Clinical lymphoma, myeloma and leukemia, Vol.22, pp.S355-S356
- DOI
- 10.1016/S2152-2650(22)01494-X
- ISSN
- 2152-2650
- eISSN
- 2152-2669
- Language
- English
- Date published
- 10/2022
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359786802771
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