Clinical trial · Interventional
Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL
Chidamide Combined With R-GemOx(Rituximab、Gemcitabine Plus Oxaliplatin) Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Multi-center, Single Arm, Phase II Study
NCT04022005CI-TRIAL-00069477completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide, Rituximab, Gemcitabine,Oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chidamide combined with R-GemOx
- description
- 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.
- interventionNames
- Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 4-years
- description
- the proportion of patients who had CR, and PR according to the revised 2014 Lugano criteria for response assessment of lymphoma.
Secondary outcomes (3)
- measure
- DOR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (1)
- DERIVEDZou Q, Zhang Y, Zhou H, Lai Y, Cao Y, Li Z, Su N, Li W, Huang H, Liu P, Ye X, Wu Y, Tan H, Zheng R, Wu B, Yang H, Zhong L, Lu Y, Liang Y, Sun P, Li L, Liu Y, Dai D, Xia Y, Cai Q. Chidamide, a Histone Deacetylase Inhibitor, Combined With R-GemOx in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (TRUST): A Multicenter, Single-Arm, Phase 2 Trial. Cancer Med. 2025 May;14(9):e70919. doi: 10.1002/cam4.70919. PMID 40318003