MedTrace Logo

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

NCT05784987 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-27

No results posted yet for this study

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).

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

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

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Wei Xu, PhD& MD · The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-15
Primary Completion
2024-01-01
Completion
2025-01-01

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05784987 on ClinicalTrials.gov