Peripheral T-cell Lymphoma
Conditions
Interventions
Experimental Group:pegaspargase+CHOP regimen
Control Group:Hyper-CVAD regimen
Sponsors
First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years old; 2. The patient has peripheral T-cell lymphoma that is confirmed by histology or cytology. If can't obtain the tumor tissue while filtrating,the pathological diagnosis confirmed by formerly biopsy is admissible; 3. The patient had not received any systemic treatment that aimed at peripheral T-cell lymphoma before enrolling the experiment; 4. The patient should sign informed consent before any examination connected with the experiment,and the patient should know that he or she have rights to drop out of the experiment at any time and won't impact following treatment; 5. No act infectious disease; 6. Main visceral organ don't have serious organic diseases(except renal insufficiency caused by this lymphomatous disease), conforming to the laboratory inspection requirement bellow(conducted within seven days before the treatment): 1) Total bilirubin= (the same age group) 1.5 times of upper level of normal range; 2) AST and ALT=(the same age group) 2.5 times of upper level of normal range; 3) Myocardial enzyme<(the same age group) double of upper level of normal range; 4) Ejection fraction detected by cardiac ultrasonography is in the range of normal value.
Exclusion criteria
Exclusion criteria: 1. Have incorporate tumor that is not corresponded with peripheral T-cell lymphoma in primary lesionor histology before or now; 2. Congestive heart-failure>New York Heart Association class 2; 3. Active coronary artery disease(patient who has myocardial infarction six monthes ago before enrollment can be enrolled); 4. Have arrhythmia and need antiarrhythmic treatment(expect beta adrenergic receptor?calcium ion antagonist or digoxin); 5. Uncontrollable hypertension (diastolic blood pressure can’t be controlled within 90mmHg even treated with three types of dyazide); 6. Renal insufficiency need hematodialysis or peritoneal dialysis; 7. Have serious thrombus event before treatment; 8. Need take medicine of warfarin for long time because of atrial fibrillation or other reason; 9. Received major operation within 30 days before enrollment; 10. ECOG score >3; 11.Known human immunodeficiency virus (HIV) infection; 12. Have history of malignancy expect of peripheral T-cell lymphoma,unless the disease be cured more than 3 years; 13. Serious infection disease (uncurative tuberculosis, pulmonary aspergillosis); 14. Have epilepsy, dementia or other psychiatric symptoms which need drug therapy and can not understand or obey the study protocol; 15. Have obvious clinically gastrointestinal bleeding within 30 days before enrollment; 16. Allosome organ transplantation history; 17. Drug abusing and medical, psychological or societal factor that may interfere patient to participate in the study or have influence in the evaluation of research results; 18. Known or suspected drug allergy of tested drug or any given drug that is related to the experiment; 19. Pregnant or lactational patient. Fertile woman must be given pregnancy test seven days before test and the result must be negative. Male and female that involved in the test must adopt plenitudinous contraceptives in the course of experiment; 20. Incorporative treatment or drug that need excluded agone and now; 21. Received any systemic treatment that aimed at peripheral T-cell lymphoma before enrolling the experiment, such as chemotherapy, immunological therapy and hormonotherapy (expect of hormone as supportive treatment); 22. Received investigation product treatment that aimed at peripheral T-cell lymphoma before; 23. Received bone marrow transplantation or stem cell supporting four months before using the investigation product; 24. The investigator consider unsuitable to enroll.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number and size of lesions;blood routine examination;blood biochemistry;ß2-microglobulin;bone marrow smear;bone marrow biopsy;bone marrow immunophenotyping;karyotype;minimal residual disease;vital sign; | — |
Secondary
| Measure | Time frame |
|---|---|
| coagulation function;immune globulin;tumor marker;hepatitis virus;Elzatein-Barn virus;cytomegalovirus;microvirus;Chest X-ray examination;ECG; | — |
Countries
China
Contacts
Public ContactHe Huang
First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed