Clinical trial · Interventional
Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma
A Multi-center, Prospective, Single-arm, Open Label Phase II Study of Chidamide Combined With Chemotherapy in the Treatment of Peripheral T Cell Lymphoma
NCT02753543CI-TRIAL-00030351unknownPhase 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 single arm, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.
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 |
|---|---|---|---|
| Peripheral T Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chidamide plus previous chemotherapy
- description
- Chidamide 20mg/d Biw p.o. on d1,4,8,11 for of each cycle for 3 cycles
- interventionNames
- Drug: Chidamide
Primary outcomes (1)
- measure
- complete response
- timeFrame
- 21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)
Secondary outcomes (3)
- measure
- Progression free survival
- timeFrame
- 1 year
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically verified peripheral T-cell lymphoma, partial response or stable disease after 3 cycles of CEOP (cyclophosphamide, epirubicin or doxorubicin, vincristine and prednisone) or CEOP(cyclophosphamide,vincristin,epirubicin and prednisone)/IVE (ifosfamide, epirubicin, etoposide)/GDP(Gemcitabine, Cis-platinum, Dexamethasone) * Age ≧16 years, ≦75 years * ECOG (Eastern Cooperative Oncology Group) =0,1,2 * No previous history of malignancy * Radiologically measurable disease * Life expectancy\>6 months * Informed consented Exclusion Criteria: * Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy * Lab at enrollment(unless caused by lymphoma) * Neutrophile\<1.5\*10\^9/L * Platelet\<75\*10\^9/L * Hemoglobulin\<90g/L * ALT(alanine aminotransferase) or AST (aspartate aminotransferase ) \>2\*ULN,AKP(alkaline phosphatase) or bilirubin \>1.5\*ULN (upper limit of normal ) * 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
References
Publications (0)
Data not yet available
No reference posted for this study.