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

Not Applicable

• Conditions: Peripheral T Cell Lymphoma
• Interventions: Drug: Chidamide

• Registration Number: NCT03268889
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Study Timeline

• Study Start: 2017-06-15
• Status Verified: 2017-08
• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-08-30
• Last Update Submitted: 2017-08-30
• Study First Posted: 2017-08-31
• Last Update Posted: 2017-08-31
• Primary Completion: 2020-06-15
• Study Completion: 2020-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	Chidamide	In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone.

Primary Outcome Measures

Name	Time	Method
Complete Remission Rate	every 3 months until 30 months after the last patient's enrollment	the rate of patients who achieve complete remission after the treatment

Secondary Outcome Measures

Name	Time	Method
duration of remission	from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment	from date of complete remission to date of progression, relapse, or death from any cause
progression free survival	from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment	from date of inclusion to date of progression, relapse, or death from any cause
overall survival	30 months after the last patient's enrollment	from the date of inclusion to date of death, irrespective of cause
adverse events	from the date of first cycle of treatment to 30 months after last patient's enrollment	any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure

Trial Locations

Locations (1)

the First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China