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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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.
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.
Complete response rate (CRR)
Response is assessed according to the lugano criteria.
Time frame: every 2 cycles, up to 4 cycles (each cycle is 21 days)
Objective response rate (ORR)
Response is assessed according to the lugano criteria.
Time frame: every 2 cycles, up to 4 cycles (each cycle is 21 days)
Duration of response (DoR)
The time from the first assessment of CR or PR for the tumor to the first assessment of recurrence or PD or death from any cause.
Time frame: 2 years
Progression-free survival (PFS)
PFS was defined as the time between randomization and the first date of progression, relapse, or death from any cause.
Time frame: 2 years
Overall survival (OS)
From the date of randomization to date of death, irrespective of cause.
Time frame: 2 years
Adverse events (AEs)
The incidence, type, and severity of adverse events (graded according to CTCAE v5.0), and their relationship to the study treatment.
Time frame: From the start of treatment to 28 days after the end of treatment.
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