Clinical trial · Interventional
Chidamide Combined With VDDT Regimen in the Relapse and Refractory Diffuse Large B Cell Lymphoma
The Efficacy and Safety of Chidamide Combined With VDDT Regimen（Vinorelbine，Liposomal Doxorubicin，Dexamethasone and Thalidomide） in Relapse and Refractory Patients With Diffuse Large B Cell Lymphoma
NCT02733380CI-TRIAL-00044396unknownPhase 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 phase II clinical trial to observe the efficacy and safety of Chidamide combined with VDDT(vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide) in relapsed and refractory patients with diffuse large B-cell lymphoma(DLBCL).
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Liposomal Doxorubicin or mitoxantrone | Drug | — | UNRESOLVED |
| Thalidomide | Drug | Thalidomide | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chidamide combined with VDDT regimen
- description
- Chidamide 30mg，Oral twice a week with an interval of no less than 3 days combined with regimen：VDDT（Vinorelbine，Liposomal doxorubicin or mitoxantrone ，Dexamethasone and Thalidomide）：repeated every 14 days ，up to 12 cycles
- interventionNames
- Drug: Chidamide
- Drug: Vinorelbine
- Drug: Liposomal Doxorubicin or mitoxantrone
- Drug: Dexamethasone
- Drug: Thalidomide
Primary outcomes (4)
- measure
- objective response rate
- timeFrame
- every 8 weeks until 1 year after last patient's enrollment
- description
- the total proportion of patients with complete response（CR or CRu）and partial response（PR）
- measure
- adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed as diffuse large B-cell Lymphoma based on the 2008 WHO classification of tumors of haematopoietic and lymphoid tissues 2. Failed with second-line therapy 3. Having at least one measurable lesions 4. Age between 18 to 75 years old 5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1 6. Neutrophils more than 1.5\*10\^9/L; Platelets more than 90\*10\^9/L Hemoglobin: more than 90g/L. 7. Life expectancy no less than 3 months 8. No receiving chemotherapy in 4 weeks before enrollment 9. Agreeing to sign the written informed consents Exclusion Criteria: 1. Pregnant ，lactating and patients at reproductive age who refuse to practice contraception 2. QTc prolonging \>450ms，ventricular tachycardia，atrial fibrillation，cardiac conduction block， myocardial infarction in less than 1 year， congestive heart failure，coronary heart disease which needs medication. 3. Organ transplant recipients 4. Active bleeding 5. Thrombus，embolism，cerebral hemorrhage，cerebral infarction 6. Important organ operation in less than 6 weeks 7. Abnormal liver function（Note：total bilirubin \>1.5 times the upper limit of normal，AST or ALT \>2.5 times the upper limit of normal （Note：5 times the upper limit of normal for patients with liver involvement）），abnormal renal function（Note：serum creatinine \>1.5 times the upper limit of normal），fluid and electrolyte disorders 8. Mental illness or unable to sign the informed consent 9. Drug addiction history or alcoholism which may interfere the experimental results. 10. Researchers determine unsuited to participate in this trial 11. Known allergy to any kind of study drugs
References
Publications (12)
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- RESULTMorin RD, Mendez-Lago M, Mungall AJ, Goya R, Mungall KL, Corbett RD, Johnson NA, Severson TM, Chiu R, Field M, Jackman S, Krzywinski M, Scott DW, Trinh DL, Tamura-Wells J, Li S, Firme MR, Rogic S, Griffith M, Chan S, Yakovenko O, Meyer IM, Zhao EY, Smailus D, Moksa M, Chittaranjan S, Rimsza L, Brooks-Wilson A, Spinelli JJ, Ben-Neriah S, Meissner B, Woolcock B, Boyle M, McDonald H, Tam A, Zhao Y, Delaney A, Zeng T, Tse K, Butterfield Y, Birol I, Holt R, Schein J, Horsman DE, Moore R, Jones SJ, Connors JM, Hirst M, Gascoyne RD, Marra MA. Frequent mutation of histone-modifying genes in non-Hodgkin lymphoma. Nature. 2011 Jul 27;476(7360):298-303. doi: 10.1038/nature10351. PMID 21796119
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- RESULTDong M, Ning ZQ, Xing PY, Xu JL, Cao HX, Dou GF, Meng ZY, Shi YK, Lu XP, Feng FY. Phase I study of chidamide (CS055/HBI-8000), a new histone deacetylase inhibitor, in patients with advanced solid tumors and lymphomas. Cancer Chemother Pharmacol. 2012 Jun;69(6):1413-22. doi: 10.1007/s00280-012-1847-5. Epub 2012 Feb 24.