Experimental Tumor
Conditions
Brief summary
Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial
Detailed description
Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients.
Interventions
DRUGChidamide
Chidamide 15mg orally BIW. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
DRUGCyclophosphamide
Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
DRUGDoxorubicin
Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
DRUGVincristine
Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
DRUGEtoposide
Etoposide (100mg/m2) was administered intravenously on d1,2,3.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
DRUGPrednisone
Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Sponsors
Peking University International Hospital
Shandong Tumor Hospital
Jiangxi Provincial Cancer Hospital
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete remission (CR）rate | up to 2 years | The rate of patients who achieve complete remission after the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate（ORR） | up to 2 years | The total proportion of patients with complete response（CR）and partial response（PR）. |
| progression-free survival（PFS） | 2 years | Time from treatment until disease progression or death. |
| overall survival（OS） | 2 years after the last patient's enrollment. | From the date of inclusion to date of death, irrespective of any cause. |
Countries
China
Contacts
Primary ContactJun Zhu, Dr.
Backup ContactYuqin Song, Dr.
Outcome results
None listed