Status:
UNKNOWN
Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma)
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Peripheral T Cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
NA
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
- 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）;
- De novo peripheral T cell lymphoma patients;
- Age 18-70 years old;
- ECOG≤2；
- 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;
- The patient should have evaluable foci (lymphnodes with diameter≥1.0cm, or evaluable skin foci);
- Willing to sign a written consent.
Exclusion
- T lymphoblast lymphoma;
- Bone marrow infiltrated with lymphoma cell ≥25%；
- NT/T cell lymphoma;
- Granuloma fungoides;
- Severe impaired liver/ renal function (ALT, Bilirubin or creatinine \>3 times the normal maximum);
- Uncontrolled infection;
- Organic cardiopathy with clinical manifestation or impaired cardiac function (NYHA ≥ level 2);
- With other tumors;
- With other condition that cause the patient unable to sign the written consent;
Key Trial Info
Start Date :
June 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2020
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03268889
Start Date
June 15 2017
End Date
September 15 2020
Last Update
August 31 2017
Active Locations (1)
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1
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006