T lymphoblastic lymphoma and NK/T cell lymphoma
Conditions
Interventions
experiment group:mitoxantrone hydrochloride liposome , etoposide, cytarabine and cyclophosphamide (PLMEAC)
Sponsors
Xinqiao Hospital Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.age range18-60 yeas old; 2.NK/T-cell lymphoma and T-lymphoblastic lymphoma diagnosed by histopathology need fist-line consolidation treatment or relapsed and refractory salvage treatment 3.ECOG score<2; 4.patients who are willing to undergo autologous hematopoietic stem cel transplantation; 5.the nubmer of CD34 +cells is =2×106Kg; 6.the adequate organ function level: (1) Liver: aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=3 times the upper limit of normal value (ULN), total bilirubin (TBIL)=1.5×ULN (AST and ALT = 5× ULN are allowed in case of liver invasion); (1) Kidney: Serum creatinine = 1.5× ULN; (3) Coagulation function: INR and APTT)=1.5×ULN; (4) Normal cardiac function: that is, normal or abnormal ECG examination has no clinical significance, left ventricular ejection fraction (LVEF) shown by echocardiography is greater than 60 or CK-MB of myocardial zymogram is normal, and pro-BNP is less than 900 pg/ml; 7.Female subjects with reproductive ability must have negative serum pregnancy test results before taking the study drug for the first time; Male or female subjects with reproductive ability must use highly effective contraceptive methods throughout the study; 8.voluntarily participated in the study.
Exclusion criteria
Exclusion criteria: 1.cardiac function: (1) impaired cardiac function or obvious heart disease: myocardial infarction, congestive heart failure, heart disease with symptoms requiring drug treatment, such as unstable angina pectoris, arrhythmia, uncontrolled severe hypertension, viral myocarditis or persistent cardiomyopathy within 6 months; (2).The cardiac function is Grade III ~IV; (3) Left ventricular ejection fraction 480 ms;; 2.Infectious disease screening: hepatitis B surface antigen is positive and HBV-DNA titer exceeds the upper limit of the research center, hepatitis C antibody is positive and HCV-RNA titer exceeds the upper limit of the research center, and human immunodeficiency virus (HIV) antibody is positive in the initial screening; 3.There are contraindications to any PLMEAC pharmaceutical ingredient; 4.Accompanied by central nervous system lymphoma metastasis or pia mater metastasis; 5.Other malignant tumors in the past or at present, except fully treated skin basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ; 6.Suffering from acute symptomatic pancreatitis or chronic pancreatitis within 4 weeks before screening; 7.Major surgery has been performed within 4 weeks before screening or major surgery is expected; 8.Suffered from severe infection within 4 weeks before screening, and the researcher judged that chemotherapy was not suitable; 9. Have a history of deep vein thrombosis or pulmonary embolism; 10. Diabetes with poor control during screening; 11.History of active bleeding within 3 months before screening; 12.Those who have a history of drug abuse (using narcotic drugs or psychotropic drugs for non-medical purposes) or drug dependence (sedative hypnotics, analgesics, anesthetics, stimulants and quasi-psychotic drugs, etc.); 13.Any history of mental illness or cognitive impairment; 14.Pregnant or lactating women or those who have family planning within 12 months; 15.the researcher considers unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progressive free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;engraftement;overall survival;adverse event; | — |
Countries
China
Contacts
Public ContactGao Li
Xinqiao Hospital Army Medical University
Outcome results
None listed