NCT05823701

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Chidamide	20 mg (4 capsules), d1, d4, d8, d11 orally per cycle
DRUG	Azacitidine	100mg d1- d5 subcutaneous injection per cycle
BIOLOGICAL	obinutuzumab	1000mg d4 intravenous infusion per cycle
DRUG	Liposomal mitoxantrone	20mg/m2 d5 intravenous infusion per cycle

Timeline

• Start date: 2022-09-30
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2023-04-21
• Last updated: 2023-04-21

Locations

1 site across 1 country: China