Clinical trial NCT03268889: Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma)
Official title: Chidamide With Cyclophosphamide, Etoposide, Vincristine and Prednisone for de Novo Peripheral T Cell Lymphoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral T Cell Lymphoma
Keywords: Chidamide, CHOP regimen
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients.

Detailed description: After enrollment, patients in this study will be given Chidamide, Cyclophosphamide, Epirubicin, Vincristine and Prednisone, and the efficacy and safety of this regimen are then evaluated.

Eligibility criteria: 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;

Primary outcomes:
measure: Complete Remission Rate
timeFrame: every 3 months until 30 months after the last patient's enrollment
Secondary outcomes:
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
measure: duration of remission
timeFrame: from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
measure: overall survival
timeFrame: 30 months after the last patient's enrollment
measure: adverse events
timeFrame: from the date of first cycle of treatment to 30 months after last patient's enrollment
Other outcomes:
Locations:
city: Suzhou
country: China
facility: the First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Zhengming Jin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: