Status:
COMPLETED
Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL
Lead Sponsor:
Sun Yat-sen University
Conditions:
Lymphoma, Large B-Cell, Diffuse
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- biopsy proved CD20+ DLBCL;
- relapse or refractory DLBCL#
- 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
- double-hit lymphoma;
- previously received treatment of HDAC inhibitor;
- plan to receive autologous stem cell transplantation;
- involvement of central nervous system;
- previously received gemcitabine within the past 6 months;
- patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
Key Trial Info
Start Date :
June 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04022005
Start Date
June 19 2019
End Date
March 11 2023
Last Update
September 11 2023
Active Locations (1)
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1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 51000