Patient-reported outcome planning and reporting in CAR-T and CD3xCD20 bispecific antibody trials for relapsed/refractory lymphoma: A cross-sectional analysis (2017–2025).

Abstract

e19107 Background: Patient-reported outcomes (PROs) are increasingly prioritized in lymphoma trials to contextualize benefit-risk and treatment feasibility. However, the extent to which lymphoma trials that plan PRO collection subsequently report PRO results remains unclear, particularly across novel treatment platforms. Methods: We conducted a cross-sectional analysis of interventional adult lymphoma trials registered on ClinicalTrials.gov from January 1, 2017 through December 31, 2025 evaluating CAR-T or CD3xCD20 bispecific antibodies. For each unique trial, we abstracted whether PROs were prospectively planned in the registry (PRO endpoint and/or instrument specified), instruments used, and whether PRO results were publicly reported in any associated conference abstract or manuscript. Among trials with planned PROs and any dissemination (abstract/manuscript), we evaluated PRO reporting completeness (instrument identified, completion rates, longitudinal reporting, missing data considerations, and clinically meaningful change thresholds). Results: Seventy-four trials met inclusion criteria (61 CAR-T, 13 bispecific). PROs were prospectively planned in 20/74 (27%) trials: 16/61 (26%) CAR-T and 4/13 (31%) bispecific. Common instruments included EORTC QLQ-C30, FACT-Lym/LymS, and EQ-5D (with occasional SF-36). Among trials with planned PROs and any public dissemination (n=11), PRO results were reported in 4/11 (36%). Reporting differed by platform: 2/9 (22%) CAR-T trials vs 2/2 (100%) bispecific trials reported planned PRO results. When PROs were reported, completeness was heterogeneous: dedicated PRO manuscripts demonstrated longitudinal trajectories, completion rates, and clinically interpretable change metrics, whereas several efficacy publications/abstracts omitted planned PRO findings. Conclusions: In modern lymphoma trials, PRO assessment is planned in only 1 in 4 studies, and most trials with planned PROs do not report PRO results when outcomes are disseminated. Standardized expectations for PRO reporting (including completion, longitudinal change, and clinically meaningful thresholds) are needed to improve transparency and interpretability across CAR-T and bispecific platforms.