Clinical trial · Interventional
Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma)
Chidamide With Cyclophosphamide, Etoposide, Vincristine and Prednisone for de Novo Peripheral T Cell Lymphoma Patients
NCT03268889CI-TRIAL-00029370CHOPunknownN/AClinicalTrials.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 study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL 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 |
|---|---|---|---|
| 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
- treatment group
- description
- In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone.
- interventionNames
- Drug: Chidamide
Primary outcomes (1)
- measure
- Complete Remission Rate
- timeFrame
- every 3 months until 30 months after the last patient's enrollment
- description
- the rate of patients who achieve complete remission after the treatment
Secondary outcomes (4)
- measure
- progression free survival
- timeFrame
- from the day of treatment to the date of first documented progression,up to 30 months after the last patient's enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2008 classification criteria(NK/T cell lymphoma, ALK positive anaplastic large cell lymphoma and granuloma fungoides excluded); 2. De novo peripheral T cell lymphoma patients; 3. Age 18-70 years old; 4. ECOG≤2; 5. Female patients not in lactation nor pregnancy, and no intention to concept during the study and 12 months thereafter. Male patients agree not to impregnate his partner during the study and 12 months thereafter; 6. The patient should have evaluable foci (lymphnodes with diameter≥1.0cm, or evaluable skin foci); 7. Willing to sign a written consent. Exclusion Criteria: 1. T lymphoblast lymphoma; 2. Bone marrow infiltrated with lymphoma cell ≥25%; 3. NT/T cell lymphoma; 4. Granuloma fungoides; 5. Severe impaired liver/ renal function (ALT, Bilirubin or creatinine \>3 times the normal maximum); 6. Uncontrolled infection; 7. Organic cardiopathy with clinical manifestation or impaired cardiac function (NYHA ≥ level 2); 8. With other tumors; 9. With other condition that cause the patient unable to sign the written consent;
References
Publications (1)
- DERIVEDZong X, Yang Z, Zhou J, Jin Z, Wu D. Clinical trial: Chidamide plus CHOP improve the survival of newly diagnosed angioimmunoblastic T-cell lymphoma. Front Immunol. 2024 Aug 20;15:1430648. doi: 10.3389/fimmu.2024.1430648. eCollection 2024. PMID 39229263