To evaluate the efficacy and safety of R-CMOP regimen based on mitoxantrone hydrochloride liposome injection in the treatment of newly diagnosed diffuse large B-cell lymphoma (DLBCL) based on cardiac function screening
Compared with traditional mitoxantrone, mitoxantrone liposomes can significantly prolong the survival time of patients and reduce the cardiotoxicity and non-hematological toxicity of anthracycline drugs. Based on the cardiac safety and efficacy of mitoxantrone liposome, the R-CMOP scheme based on Mitoxantrone liposome for the treatment of initial DLBCL based on cardiac function screening has sufficient theoretical basis and is worth exploring.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Objective Response Rate(ORR)
Objective response rate (ORR) after 6 cycles of R-CMOP chemotherapy
Time frame: up to 6 cycles of chemotherapy (each cycle is 21 days)
Complete remission rate(CRR)
Complete remission rate(CRR) after 6 cycles of R-CMOP chemotherapy
Time frame: up to 6 cycles of chemotherapy (each cycle is 21 days)
Duration of remission(DOR)
Time from reaching CR or PR for the first time to disease progression
Time frame: up to 6 cycles of chemotherapy (each cycle is 21 days)
Progression-Free-Survival rate
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: 1 year
Overall survival rate
from the date of inclusion to date of death, irrespective of cause
Time frame: 1 year
Adverse events (AE)
The safety of the drug was evaluated by NCI-CTC AE 5.0 standard
Time frame: From the first day of medication to 28 days after the last dose
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Vincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1
60 mg/m2, d1\~d5