Overview

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;