Clinical trial · Interventional
Chidamide Plus R-CHOP in Elderly DLBCL
A Prospective, Single Arm, Open-label, Phase II Study of Chidamide in Combination With R-CHOP in the Treatment of de Novo, Elderly, High-risk Diffuse Large B-cell Lymphoma
NCT02753647CI-TRIAL-00030368unknownPhase 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)
This is a prospective, single-arm, open-label phase II study of Chidamide in combination with R-CHOP in the treatment of de novo, elderly, high-risk diffuse large B cell lymphoma patients.
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 |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chidamide plus R-CHOP
- description
- Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Doxorubicin 50mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Chidamide 20mg/d PO d1, 4, 8, 11 Frequency every 21 days for 6 cycles
- interventionNames
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
- Drug: Chidamide
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- 21 days after 6 cycles of treatment (each cycle is 21 days)
Secondary outcomes (4)
- measure
- Progression free survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 61 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive * Age 61-75 years * ECOG 0,1,2 * Life expectancy\>6 months * Informed consented * IPI\>1 Exclusion Criteria: * Chemotherapy before * Stem cell transplantation before * History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease * Primary CNS lymphoma * LVEF≤50% * Lab at enrollment (Unless caused by lymphoma) Neutrophile\<1.5\*10\^9/L Platelet\<75\*10\^9/L ALT or AST \>2\*ULN,AKP or bilirubin \>1.5\*ULN Creatinine\>1.5\*ULN * Other uncontrollable medical condition that may that may interfere the participation of the study * Not able to comply to the protocol for mental or other unknown reasons * Pregnant or lactation * HIV infection * If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
References
Publications (1)
- DERIVEDZhang MC, Fang Y, Wang L, Cheng S, Fu D, He Y, Zhao Y, Wang CF, Jiang XF, Song Q, Xu PP, Zhao WL. Clinical efficacy and molecular biomarkers in a phase II study of tucidinostat plus R-CHOP in elderly patients with newly diagnosed diffuse large B-cell lymphoma. Clin Epigenetics. 2020 Oct 23;12(1):160. doi: 10.1186/s13148-020-00948-9. PMID 33097085