lymphoma
Conditions
Interventions
MEAM pre-processing group:Mitoxantrone hydrochloride liposome combined with standard dose etoposide, cytarabine, MEfalan as conditioning regimen (MEAM regimen) prior to HSCT
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up; 2. Age 18-60 years old (including upper and lower limits; 3. Patients with pathological diagnosis of lymphoma who plan to undergo autologous hematopoietic stem cell transplantation; 4. The level of organ function must meet the following requirements: a) Liver: aspartate aminotransferase (AST), alanine aminotransferase (ALT) <=3 times the upper limit of normal (ULN), total bilirubin (TBIL) <=1.5×ULN (AST, ALT <=5×ULN if liver invasion is allowed); b) Kidney: serum creatinine <=1.5×ULN; c) Coagulation function: International standardized ratio (INR) and activated partial thromboplastin time (APTT) <=1.5×ULN; d) Normal cardiac function: normal or abnormal ECG examination has no clinical significance, left ventricular ejection fraction (LVEF) shown by cardiac ultrasound is greater than 60, or myocardial enzyme spectrum CK-MB is normal, pro-BNP is less than 900 pg/ml; 5. The serum pregnancy test results of fertile female subjects must be negative before the first administration of the test drug; Fertile male or female subjects must use a highly effective contraceptive method throughout the trial.
Exclusion criteria
Exclusion criteria: 1. Received doxorubicin or other anthracyclines in the past, and the total cumulative dose of doxorubicin was > 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg epirubicin for other anthracyclines); 2. Hypersensitivity to any investigational drug or its components; 3. Uncontrolled systemic diseases (such as active infections, uncontrolled hypertension, diabetes, etc.); 4. Heart function and disease meet one of the following conditions: a) Long QTc syndrome or QTc interval >480 ms; b) Complete left bundle branch block, degree II or III atrioventricular block; c) severe, uncontrolled arrhythmias requiring medical treatment; d) New York College of Cardiology grade = III; e) Cardiac ejection fraction (LVEF) less than 60%; f) A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities within the 6 months prior to recruitment. 5. Hepatitis B, hepatitis C active infection (hepatitis B surface antigen positive and hepatitis B DNA more than 1x10^3 copies /mL; More than 1x103 copies /mL of HCV RNA); 6. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 7. Previous or current co-occurrence of other malignancies (other than non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years); 8. Had primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or had a history of CNS lymphoma; 9. Pregnant and lactating women and patients of childbearing age who do not want to take contraceptive measures; 10. Have a history of drug abuse (non-medical use of narcotic drugs or psychotropic drugs) or a history of drug dependence (sedative hypnotics, analgesics, narcotics, stimulants and psychotropic drugs, etc.); 11. History of mental illness or cognitive impairment; 12. Situations in which other investigators have determined that participation in this study is not appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Neutrophil implantation time;Overall survival time;Progression-free survival time;Treatment-related adverse events;Platelet implantation time; | — |
Countries
China
Contacts
Public ContactHe Pengcheng
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed