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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
February 25, 2026
Primary Completion Date
October 30, 2027
Completion Date
December 30, 2029
Last Updated
February 5, 2026
70
ESTIMATED participants
Rituximab+Ifosfamide+Mesna+Mitoxantrone hydrochloride liposome+Etoposide
DRUG
Rituximab+Gemcitabine+Oxaliplatin
DRUG
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06026488