Lymphoma, Large B-Cell, Diffuse
Conditions
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.
Interventions
DRUGChidamide, Rituximab, Gemcitabine,Oxaliplatin
All patients enrolled in the study will accept Chidamide + R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) as their salvage chemotherapy. Patients with CR or PR will receive chidamide maintenance therapy.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| DOR | 4-years | the time from the first CR or PR to the first documented progressive disease (PD) or death, whichever occurred earlier. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| bio-marker analysis | 4-years | Correlation between epigenetic factor mutation and efficacy |
Countries
China
Outcome results
None listed