Neoplasms

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Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

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Diffuse Large B-Cell Lymphoma

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Antineoplastic Agents, Immunological

Immunologic Factors

Enzyme Inhibitors

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Alkylating Agents

R-MINE: Rituximab, Isophosphamide, Mitoxantrone hydrochloride liposome, Etoposide

X: Orelabrutinib, Chidamide, Penpulimab, Lenalidomide

Mitoxantrone hydrochloride liposome

1.33 g/m2, d1-3(Rescue with equal dose of mesperidine), Cycle 1\~4

Isophosphamide

MCD/BN2 subtype: BTK inhibitor-Orelabrutinib: 150 mg/d, d1-21, Cycle 2\~4

X: Orelabrutinib

EZB subtype: Chidamide: 20 mg/d, d1, d4, d8, d11, Cycle 2\~4

X: Chidamide

TP53 mutation - X: PD-1 monoclonal antibody - Penpulimab: 200mg/d, d0, Cycle 2\~4

X: Penpulimab

Other-X: Lenalidomide: 25mg/d, d1-10, Cycle 2\~4

X: Lenalidomide

Jinhua Liang, M.D

Wei Xu, PhD& MD

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.

R-MINE+X in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

An Open, Single-arm, Multi-center Clinical Trial of Molecular Subtype-guided R-MINE+X Regimen in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Objective response rate (ORR) after 4 cycles of R-MINE+X chemotherapy

Complete remission rate(CRR) after 4 cycles of R-MINE+X chemotherapy

Time from reaching CR or PR for the first time to disease progression

from date of inclusion to date of progression, relapse, or death from any cause

from the date of inclusion to date of death, irrespective of cause

The safety of the drug was evaluated by NCI-CTC AE 5.0 standard

Spots Global Cancer Trial Database for x: lenalidomide