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.
They voluntarily participated in the study and signed the informed consent.
Age 18 or higher;
Expected survival time for 3 months or more;
The histopathological diagnosed late relapsed (> 12 months) diffuse large B cell lymphoma;
Prior treatment with mitoxantrone or liposomal mitoxantrone;
Prior treatment with doxorubicin or other anthracyclines, with a total cumulative doxorubicin dose >360 mg/m² (for other anthracyclines, 1 mg of doxorubicin is equivalent to 2 mg of epirubicin);
Prior autologous hematopoietic stem cell transplantation within 100 days before the first dose, or a history of allogeneic hematopoietic stem cell transplantation;
Prior antitumor therapy (including chemotherapy, targeted therapy, hormone therapy, traditional Chinese medicine with antitumor activity, etc.) or participation in other clinical trials involving investigational drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug.
Parallel
Rituximab+Ifosfamide+Mesna+Mitoxantrone hydrochloride liposome+Etoposide
DrugRituximab 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+Gemcitabine+Oxaliplatin
DrugRituximab 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.
Objective response rate (ORR)
Response is assessed according to the lugano criteria.
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.
Progression-free survival (PFS)
PFS was defined as the time between randomization and the first date of progression, relapse, or death from any cause.
Overall survival (OS)
From the date of randomization to date of death, irrespective of cause.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
