Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL

• Status: Recruiting
• Trial end date: 2023-09-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Gemcitabine; Oxaliplatin; Rituximab

Criteria

Inclusion Criteria:

• biopsy proved CD20+ DLBCL;

• first relapse or refractory；

• previously received systemic chemotherapy with anthracycline；

• not eligible for autologous hematopoietic stem cell transplantation；

• at least one evaluable lesion；

• ECOG PS 0-1;

• 18-75 years; without other malignancy;

• proper functioning of the major organs.

Exclusion Criteria:

• double-hit lymphoma;

• previously received treatment of HDAC inhibitor;

• plan to receive autologous stem cell transplantation;

• involvement of central nervous system;

• previously received more than one chemotherapy regimen;

• patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;