Trial reportBMC medicine2026
R-MINE-containing regimen in relapsed and refractory diffuse large B-cell lymphoma: a single-arm, multicenter phase II study.
Trial report in BMC medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05784987 (An Open, Single-arm, Multi-center Clinical Trial of Molecular Subtype-guided R-MINE+X Regimen in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open, Single-arm, Multi-center Clinical Trial of Molecular Subtype-guided R-MINE+X Regimen in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
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Authors and funding
14 authors.
Funding
Abstract
backgroundImproving the prognosis of patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) remains an unmet need. This multicenter, phase II study (NCT05784987) aimed to assess the efficacy and safety of a mitoxantrone hydrochloride liposome (Lipo-MIT)-based rituximab with mitoxantrone/ifosfamide/mesna/etoposide (R-MINE)-containing regimen, in which conventional mitoxantrone was replaced with Lipo-MIT, with or without a targeted agent.
methodsPatients older than 18 years with histologically confirmed R/R DLBCL were enrolled. All enrolled patients received an R-MINE-containing regimen in 21-day cycles for up to four cycles. The addition of the targeted agent (X) was individualized according to prior treatment resistance and molecular subtype. The primary endpoint was objective response rate (ORR).
resultsFrom March 27, 2023, to July 10, 2025, 60 patients were enrolled. Of the 55 efficacy-evaluable patients, the ORR was 76.4% (95% confidence interval [CI]: 63.0%-86.8%), and the complete response rate was 52.7% (95% CI: 38.8%-66.3%). With the median follow-up of 13.9 months, the median PFS was 17.5 months (95% CI: 10.8-24.2), and the estimated PFS rate at 1 year was 58.5%. The median OS was not reached, with an estimated 1-year OS rate of 84.0%. Late relapse after the last-line therapy was identified as the only independent predictor for ORR, with an ORR of 86.4%. Grade ≥ 3 treatment-related adverse events (TRAEs) occurred in 46.7% of patients, with neutropenia (33.3%) being the most common. No serious TRAEs or TRAE-related deaths occurred.
conclusionsThe Lipo-MIT-based R-MINE-containing regimen showed encouraging efficacy and a manageable safety profile in R/R DLBCL, warranting further validation. CLINICAL
trial registrationThis trial is registered with ClinicalTrials.gov (NCT05784987). URL https//clinicaltrials.gov/study/NCT05784987.
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