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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT07389356
Status
Not Yet Recruiting

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Conditions

  • DLBCL - Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 25, 2026
Status verified
Jan 2026
Primary completion
Oct 30, 2027
Completion
Dec 30, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: modified R-MINE
  • Active Comparator: R-GemOx

Primary Outcome Measure

Complete response rate (CRR) [ Time Frame: every 2 cycles, up to 4 cycles (each cycle is 21 days) ]

Central Contacts

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