Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL
Phase 2
Completed
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Interventions
- Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin
- Registration Number
- NCT04022005
- Lead Sponsor
- Sun Yat-sen University
- 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 transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- 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 Criteria
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chidamide combined with R-GemOx Chidamide, Rituximab, Gemcitabine,Oxaliplatin Chidamide, 20 mg,twice per week; Rituximab 375mg/m2, d1, intravenous drip; Gemcitabine 1000mg/m2, d2, intravenous drip; Oxaliplatin 100mg/m2, d2,intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive chidamide maintenance therapy.
- Primary Outcome Measures
Name Time Method ORR 4-years the proportion of patients who had CR, and PR according to the revised 2014 Lugano criteria for response assessment of lymphoma.
- Secondary Outcome Measures
Name Time Method PFS 4-years the time from the date of enrollment until either PD or death.
OS 4-years the time from the date of enrollment until death
DOR 4-years the time from the first CR or PR to the first documented progressive disease (PD) or death, whichever occurred earlier.
Trial Locations
- Locations (1)
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China