Clinical trial NCT03617432: Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients
Official title: Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Experimental Tumor
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Peking University International Hospital
name: Shandong Tumor Hospital
name: Jiangxi Provincial Cancer Hospital
First posted: 2018-08-06
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: complete remission (CR）rate
timeFrame: up to 2 years
Secondary outcomes:
measure: objective response rate（ORR）
timeFrame: up to 2 years
measure: progression-free survival（PFS）
timeFrame: 2 years
measure: overall survival（OS）
timeFrame: 2 years after the last patient's enrollment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
References: