Clinical trial · Interventional
Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
A Non-randomized, Open-label, Phase II Study of Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Not Suitable for Transplantation
NCT03373019CI-TRIAL-00030807unknownPhase 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 goal of this clinical trial is to evaluate therapeutic efficacy of Chidamide combined with R-GDP (rituximab/gemcitabine/dexamethasone/cisplatin)in treating Patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chidamide | — | UNRESOLVED | — |
| Cisplatin | — | UNRESOLVED | — |
| Cyclophosphamide | — | UNRESOLVED | — |
| Dexamethasone | — | UNRESOLVED | — |
| Gemcitabine | — | UNRESOLVED | — |
| HDAC Inhibitor | — | UNRESOLVED | — |
| Immune System Diseases | — | UNRESOLVED | — |
| Immunoproliferative Disorders | — | UNRESOLVED | — |
| Lymphatic Diseases | — | UNRESOLVED | — |
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide combined with R-GDP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chidamide combined with R-GDP
- description
- Chidamide: 30mg,PO,biw one week before cycle 1 treatment rituximab 375 mg/m2,ivgtt D0 gemcitabine 1000mg/m2 iv D1,8 dexamethasone 40mg, iv D1-4, cisplatin 25mg/m2 iv D1-4 chidamide :20mg PO Biw, 2 week on , 1 week off
- interventionNames
- Drug: Chidamide combined with R-GDP
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 6 weeks
- description
- overall response rate
Secondary outcomes (4)
- measure
- CR
- timeFrame
- 6 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ages: 18-75 years old 2. Relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) previous treated with standard chemoimmunotherapy 3. Not willing or not suitable for hematopoietic stem cell transplantation (HSCT) 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) index \< 2 5. Informed consent available 6. Life expectancy of more than 3 months; 7. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention. 8. Bone marrow function: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L, Hb ≥ 80g/L; 9. Liver function: total bilirubin, ALT and AST were \<1.5 × UNL (the upper limit of normal value) 10. Renal function: Cr\<1.5 × UNL and creatinine clearance \> 50ml/min Exclusion Criteria: 1. Prior history of treatment of HDAC inhibitor. 2. Plan of HSCT in the future 3. Significant pericardial effusion showed by chest CT scan 4. Prior history of other cancers except treated cervical or basal cell skin carcinoma, organ transplantation 5. Syphilis or human immunodeficiency virus (HIV) infection 6. Pregnant or lactating women 7. History of organ transplantation 8. Serious active infections (including hepatitis) 9. Serious neurological or psychiatric history, including dementia or epilepsy. Termination criteria: 1. Withdrew consent 2. Researchers think it is necessary to terminate the study; 3. Disease progression or death; 4. Poor compliance 5. Subclinical or clinical cardiac toxicity; 6. Unable to continue treatment because of severe toxicity
References
Publications (0)
Data not yet available
No reference posted for this study.