Untreated High Risk T-Cell Lymphoma Adults
Conditions
Interventions
Group B:c-ATT therapy
Group A:CHOP therapy
Sponsors
Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. To be aged from 18 to 70 years; 2. Histological documented high risk T cell lymphoma: extranodal NK/T-cell, lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, angioimmunoblastic T-cell lymphoma, enteropathy-type T-cell lymphoma, peripheral T-cell lymphoma,unspecified; 3. Measurable disease and evaluatble lesion; 4. Never previously treated with radiotherapy, chemotherapy or surgery for malignant disease; 5. Normal Haematological, liver and kidney function (Neutrophil count >=1.5*10^9/L, hemoglobin >=100g/L, platelets >=100*10^9/L); 6. ECOG Performance status 0-3, Life expectancy of at least 3 months; 7. Without history of another malignancy; 8. Without any conflict serious systemic disease; 9. Without any accompany treatment (including steroids drugs); 10. Subjects must have signed and informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study; 11. Female subjects must be practicing and effective methods of birth control for at least 6 months throughout and after study; and have a negative serum Beta-hCG pregnancy test at screening.
Exclusion criteria
Exclusion criteria: 1. Patients with prior clinical study within 3 months; 2. Secondary lymphoma induced by chemotherapy or radiotherapy for another malignancy; 3. Transformed lymphoma; 4. Mycosis fungoides/Sézary syndrome(MF/SS); 5. History of allergic reaction to any ectogenic proteins; 6. Prior treatment for lymphoma; 7. History of another malignancy; 8. Neutrophil count =2* institutional upper limit of normal); 12. liver dysfunction not related to lymphoma (transaminase>=3* institutional upper limit of normal,and/or bilirubin>=2.0mg/dl); 13. clinical syndrome of encephalon functional disorder, serious psychiosis; 14. female subject who is pregnant or breast-feeding period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;response rate;disease free survival; | — |
Countries
China
Contacts
Public ContactLin TongYu
Outcome results
None listed