Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma)
Study Details
Study Description
Brief Summary
This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: treatment group In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone. |
Drug: Chidamide
Chidamide is given to the patients in this study along with CHOP regimen, to access the efficacy and safety in this cohort of PTCL patients. The dosage of the above regimen is as follows: Chidamide, 30mg,po,biw; Cyclophosphamide 750mg/m2, ivgtt, d1; Epirubicin 70mg/ m2, ivgtt, d1; Vincristine 3mg/ m2, ivgtt, d1; Prednisone 100mg/ m2, po, d1-5.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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）;
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De novo peripheral T cell lymphoma patients;
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Age 18-70 years old;
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ECOG≤2；
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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;
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The patient should have evaluable foci (lymphnodes with diameter≥1.0cm, or evaluable skin foci);
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Willing to sign a written consent.
Exclusion Criteria:
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T lymphoblast lymphoma;
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Bone marrow infiltrated with lymphoma cell ≥25%；
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NT/T cell lymphoma;
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Granuloma fungoides;
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Severe impaired liver/ renal function (ALT, Bilirubin or creatinine >3 times the normal maximum);
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Uncontrolled infection;
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Organic cardiopathy with clinical manifestation or impaired cardiac function (NYHA ≥ level 2);
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With other tumors;
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With other condition that cause the patient unable to sign the written consent;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China | 215006 |
Sponsors and Collaborators
- The First Affiliated Hospital of Soochow University
Investigators
- Principal Investigator: Zhengming Jin, MD,PhD, The First Affiliated Hospital of Soochow University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Jinzm 001