Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07389356
NA

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-02-25

Completion Date

2029-12-30

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

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.