Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma)

Soochow University

Status: Unknown

Conditions: Peripheral T Cell Lymphoma

Treatments: Drug: Chidamide

Study type: Interventional

Funder types: Other

Identifiers

NCT03268889

Jinzm 001

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

treatment group

Experimental group

Description:

In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone.

Treatment:

Drug: Chidamide