Based on the modified R-MINE of mitoxantrone hydrochloride liposome, the corresponding targeted drug (X) was added according to the genotyping detected by second-generation gene sequencing (NGS) to explore the effectiveness and safety of R-MINE+X in the treatment of recurrent/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
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. At present, there are no studies on the efficacy and safety of R-MINE+X regimen based on molecular typing in the treatment of R/R DLBCL. Therefore, based on NGS, R/R DLBCL was divided into different molecular types (MCD subtype, BN2 subtype, EZB subtype, A53 subtype and other subtype), and on this basis, different molecular types of targeted drugs (X: MCD/BN2 subtype - BTK inhibitor, EZB subtype - Chidamide, A53 subtype - PD-1 monoclonal antibody and other type - lenalidomide) were used to treat R/R DLBCL. The main purpose was to observe the effectiveness and safety of the program in R/R DLBCL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
375 mg/m2, d0, Cycle 1\~4
20 mg/m2, d1, Cycle 1\~4
1.33 g/m2, d1-3(Rescue with equal dose of mesperidine), Cycle 1\~4
Objective Response Rate(ORR)
Objective response rate (ORR) after 4 cycles of R-MINE+X chemotherapy
Time frame: up to 4 cycles of chemotherapy(each cycle is 21 days)
Complete remission rate(CRR)
Complete remission rate(CRR) after 4 cycles of R-MINE+X chemotherapy
Time frame: up to 4 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 4 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
65 mg/m2, d1-3, Cycle 1\~4
MCD/BN2 subtype: BTK inhibitor-Orelabrutinib: 150 mg/d, d1-21, Cycle 2\~4
EZB subtype: Chidamide: 20 mg/d, d1, d4, d8, d11, Cycle 2\~4
TP53 mutation - X: PD-1 monoclonal antibody - Penpulimab: 200mg/d, d0, Cycle 2\~4
Other-X: Lenalidomide: 25mg/d, d1-10, Cycle 2\~4