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R-MINE-containing regimen in relapsed and refractory diffuse large B-cell lymphoma: a single-arm, multicenter phase
Jin-Hua Liang1, Xin-Yu Zhang1, Lin-Tao Bi2
1Department of Hematology, The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital, Nanjing, 210029, China.
BMC Medicine
|July 10, 2026
Summary
This study shows a new liposome-based regimen is effective for relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The treatment demonstrated promising response rates and survival, with a manageable safety profile.
Area of Science:
- Hematology
- Oncology
- Pharmacology
Background:
- Relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) presents a significant challenge in patient care.
- Conventional treatments for R/R DLBCL have limitations, highlighting the need for novel therapeutic strategies.
Purpose of the Study:
- To evaluate the efficacy and safety of a novel liposome-mitoxantrone hydrochloride (Lipo-MIT)-based rituximab with mitoxantrone/ifosfamide/mesna/etoposide (R-MINE) regimen.
- To assess the impact of adding a targeted agent to the Lipo-MIT-based R-MINE regimen in R/R DLBCL patients.
Main Methods:
- A multicenter, phase II clinical trial (NCT05784987) was conducted.
- Patients with R/R DLBCL received the Lipo-MIT-based R-MINE regimen for up to four 21-day cycles.
- The addition of a targeted agent was individualized based on prior treatment resistance and molecular subtype.
Main Results:
- An objective response rate (ORR) of 76.4% was observed in 55 efficacy-evaluable patients.
- The complete response rate was 52.7%, with a median progression-free survival (PFS) of 17.5 months.
- Grade ≥3 treatment-related adverse events (TRAEs) occurred in 46.7% of patients, primarily neutropenia, with no serious TRAEs or deaths.
Conclusions:
- The Lipo-MIT-based R-MINE regimen demonstrates encouraging efficacy in treating R/R DLBCL.
- The regimen exhibits a manageable safety profile, suggesting its potential as a valuable treatment option.
- Further validation studies are warranted to confirm these findings.
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