Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients
Phase 2
- Conditions
- Experimental Tumor
- Interventions
- Registration Number
- NCT03617432
- Lead Sponsor
- Peking University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 114
Inclusion Criteria
- 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;
- Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD;
- Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci);
- Age 18-70 years, male or female;
- ECOG performance status 0-2;
- Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;
- ALT and serum creatinine <1.5 times of normal maximum;
- Life expectancy no less than 3 months;
- Willing to sign the Informed Consent Form.
Exclusion Criteria
- NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma;
- Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures;
- 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;
- Patients have undergone organ transplantation;
- Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;
- Patients with active hemorrhage;
- Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;
- Patients with active infection or continuous fever within 14 days prior to enrollment;
- Had major organ surgery within 6 weeks prior to enrollment;
- 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);
- Patients with mental disorders or those do not have the ability to consent;
- Patients with drug abuse, long term alcoholism that may impact the results of the trial;
- Patients with invasion of central nervous system ;
- Non-appropriate patients for the trial according to the judgment of the investigators.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Doxorubicin Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles. Experimental group Cyclophosphamide Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles. Experimental group Chidamide Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles. Experimental group Vincristine Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles. Experimental group Etoposide Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles. Control group Cyclophosphamide Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles. Experimental group Prednisone Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles. Control group Doxorubicin Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles. Control group Vincristine Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles. Control group Etoposide Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles. Control group Prednisone Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.
- Primary Outcome Measures
Name Time Method complete remission (CR）rate up to 2 years The rate of patients who achieve complete remission after the treatment.
- Secondary Outcome Measures
Name Time Method overall survival（OS） 2 years after the last patient's enrollment. From the date of inclusion to date of death, irrespective of any cause.
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.
Trial Locations
- Locations (1)
Beijing Cancer Hospital
🇨🇳Beijing, China