Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

Analgesics

All Drugs and Chemicals

Mitoxantrone

Azacitidine

Obinutuzumab

Antimetabolites

Enzyme Inhibitors

Antineoplastic Agents, Immunological

R/R DLBCL patients were treated with 2 cycles of CAGM regimen including chidamide, azacitidine, obinutuzumab and liposomal mitoxantrone followed by imaging examination. Patients achieved CR/PR were exposed to ASCT/CAR-T therapy or additional 4 cycles of CAGM regimen in patients ineligible for ASCT/CAR-T therapy; whereas, patients with SD/PD were withdrawn from this study.

20 mg (4 capsules), d1, d4, d8, d11 orally per cycle

Chidamide

100mg d1- d5 subcutaneous injection per cycle

obinutuzumab

20mg/m2 d5 intravenous infusion per cycle

Liposomal mitoxantrone

Zhengming Jin

Changju Qu

To evaluate the efficacy and safety of CAGM regimen in R/R DLBCL patients and to provide a safe and more effective approach for R/R DLBCL patients.

The study will start with an initial 2 cycles of induction therapy with CAGM containing chidamide, azacitidine, obinutuzumab and mitoxantrone liposome, orelabrutinib and rituximab，following imaging examinations to evaluate response rates. For patients feasible to CAR-T/ASCT, sequential CAR-T/ASCT treatment was given. For patients who were unable to undergo CAR-T/ASCT, 4 cycles of CAGM immunochemotherapy were carried out. Efficacy and safety of CAGM regimen in R/R DLBCL will be evaluated.

Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients

A Phase 2 Study of Chidamide, Azacitidine Combined With GM Regimen for Patients With Relapsed and Refractory DLBCL

The rate of patients who achieved CR or PR after treatment by CAGM regimen

The rate of patients who achieved CR after treatment by CAGM regimen

The safety and tolerability of the therapeutic regimen measured by the incidence of treatment-emergent adverse events, treatment-related adverse events and serious adverse events.

PFS will be assessed from the first CAGM given to date of progression, relapse, death or end of follow-up.

OS will be assessed from the first CAGM given to date of death or end of follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients	NCT05823701	Diffuse Large B...	Chidamide Azacitidine obinutuzumab Liposomal mitox...	18 Years -	The First Affiliated Hospital of Soochow University
Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients	NCT05823701	Diffuse Large B...	Chidamide Azacitidine obinutuzumab Liposomal mitox...	18 Years -	The First Affiliated Hospital of Soochow University
Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients	NCT05823701	Diffuse Large B...	Chidamide Azacitidine obinutuzumab Liposomal mitox...	18 Years -	The First Affiliated Hospital of Soochow University
Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients	NCT05823701	Diffuse Large B...	Chidamide Azacitidine obinutuzumab Liposomal mitox...	18 Years -	The First Affiliated Hospital of Soochow University

Spots Global Cancer Trial Database for liposomal mitoxantrone