Clinical trial · Interventional
Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients
Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial
NCT03617432CI-TRIAL-00034680unknownPhase 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)
Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial
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 |
|---|---|---|---|
| Experimental Tumor | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.
- interventionNames
- Drug: Chidamide
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Etoposide
- Drug: Prednisone
- type
- EXPERIMENTAL
- label
- Control group
- description
- Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Etoposide
- Drug: Prednisone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathology / cytology diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2016 classification criteria(NK/T cell lymphoma and ALK positive anaplastic large cell lymphoma excluded)including:Peripheral T-cell lymphoma, NOS,Angioimmunoblastic T-cell lymphoma,Anaplastic large-cell lymphoma, ALK negative,Enteropathy-associated T-cell lymphoma,Hepatosplenic T-cell lymphoma,Subcutaneous panniculitis T-cell lymphoma,Mycosis fungoides,Other T-cell lymphoma that investigators consider to be appropriate to be enrolled; 2. Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD; 3. Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci); 4. Age 18-70 years, male or female; 5. ECOG performance status 0-2; 6. Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L; 7. ALT and serum creatinine \<1.5 times of normal maximum; 8. Life expectancy no less than 3 months; 9. Willing to sign the Informed Consent Form. Exclusion Criteria: 1. NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma; 2. Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures; 3. QTc elongation with clinical significance ( male\> 450ms, female\> 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment; 4. Patients have undergone organ transplantation; 5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment; 6. Patients with active hemorrhage; 7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction; 8. Patients with active infection or continuous fever within 14 days prior to enrollment; 9. Had major organ surgery within 6 weeks prior to enrollment; 10. Impaired liver function ( Total bilirubin \> 1.5 times of normal maximum, ALT/AST\> 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST\> 5 times of normal maximum), impaired renal function (serum creatinine\> 1.5 times of normal maximum); 11. Patients with mental disorders or those do not have the ability to consent; 12. Patients with drug abuse, long term alcoholism that may impact the results of the trial; 13. Patients with invasion of central nervous system ; 14. Non-appropriate patients for the trial according to the judgment of the investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.