NCT05784987

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	375 mg/m2, d0, Cycle 1\~4
DRUG	Mitoxantrone hydrochloride liposome	20 mg/m2, d1, Cycle 1\~4
DRUG	Isophosphamide	1.33 g/m2, d1-3(Rescue with equal dose of mesperidine), Cycle 1\~4
DRUG	Etoposide	65 mg/m2, d1-3, Cycle 1\~4
DRUG	X: Orelabrutinib	MCD/BN2 subtype: BTK inhibitor-Orelabrutinib: 150 mg/d, d1-21, Cycle 2\~4
DRUG	X: Chidamide	EZB subtype: Chidamide: 20 mg/d, d1, d4, d8, d11, Cycle 2\~4
DRUG	X: Penpulimab	TP53 mutation - X: PD-1 monoclonal antibody - Penpulimab: 200mg/d, d0, Cycle 2\~4
DRUG	X: Lenalidomide	Other-X: Lenalidomide: 25mg/d, d1-10, Cycle 2\~4

Timeline

• Start date: 2023-04-15
• Primary completion: 2024-01-01
• Completion: 2025-01-01
• First posted: 2023-03-27
• Last updated: 2023-03-27