NCT07389356

Modified R-MINE Regimen vs. R-GemOx Regimens on the Treatment of Late Relapsed DLBCL

Rituximab, Ifosfamide, Mitoxantrone Liposome, Etoposide (Modified R-MINE) Regimen vs. Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) Regimen in the Treatment of Late Relapsed Diffuse Large B-cell Lymphoma: A Multicenter, Open, Randomized, Controlled, Phase II Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was a multicenter, open, randomized controlled, phase II clinical study. Is expected in 70 cases of late relapsed diffuse large B cell lymphoma, were randomly assigned to receive mitoxantrone liposomes modified R - MINE plan or R - GemOx treatment. Each cycle was 3 weeks (21 days) for a total of 4 cycles. Subjects assigned to each signed informed consent to screening, screening, in the center of the study determined in accordance with the order signed informed consent. Before the start of the trial, the number of random seeds was set by the statistician, and the block randomization method was used to generate the subject random table using R 4.3.3 (or above). The random ratio between the modified R-mine group and the R-Gemox group was 1:1. After the investigator determined that the subjects were screened successfully, the subjects were randomly numbered according to the order in which the eligible subjects were screened successfully. The intervention was performed by the principal investigator or by someone designated by the principal investigator. Study includes screening period (the first 28 days), treatment period (plan 4 cycles, treatment after 2 cycles enhanced CT/MRI or PET - CT mid-term efficacy, PET - CT curative effect evaluation) after treatment, follow-up (follow-up curative effect, safety and survival follow-up follow-up). Participants provided written informed consent and underwent baseline examinations during the screening period. Participants who met the inclusion criteria and none of the exclusion criteria entered the treatment period. All the study participants completed protocol-specified examinations during the course of treatment to observe efficacy and safety. The end of the treatment period was followed by the follow-up period.

Conditions

• DLBCL - Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab+Ifosfamide+Mesna+Mitoxantrone hydrochloride liposome+Etoposide	Rituximab 375 mg/m\^2, d0; Ifosfamide 1.33 g/m\^2, d1-3 (equal dose of mesna rescue); Mitoxantrone hydrochloride liposome 12mg/m\^2, d1; Etoposide 65 mg/m\^2, d1-3; Every 21 days as one cycle, and 4 cycles were planned.
DRUG	Rituximab+Gemcitabine+Oxaliplatin	Rituximab 375 mg/m\^2, d0; Gemcitabine 1000 mg/m\^2, d1; Oxaliplatin 100 mg/m\^2, d1; Every 21 days as one cycle, and 4 cycles were planned.

Timeline

• Start date: 2026-02-25
• Primary completion: 2027-10-30
• Completion: 2029-12-30
• First posted: 2026-02-05
• Last updated: 2026-02-05