Non-hodgkin's lymphoma
Conditions
Interventions
Experimental group:Bendamustine + cytarabine + etoposide + mitoxantrone liposomes
Sponsors
The First Affiliated Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with follow-up; 2. Patients with non-Hodgkin lymphoma or malignant lymphoma confirmed by histology or pathology, aged 18~75 years old (including the upper limit), regardless of gender, are planned to undergo autologous hematopoietic stem cell transplantation; 3. Eastern Cooperative Oncology Group (ECOG) physical condition: score of 0~2 points, expected survival of more than 3 months; 4. Patients judged by the investigator to be suitable for stem cell transplantation: consolidation therapy after first-line induction chemotherapy for aggressive non-Hodgkin lymphoma with poor prognostic factors; It is suitable for salvage therapy for chemotherapy-sensitive non-Hodgkin lymphoma after recurrence; and salvage therapy for chemotherapy-sensitive, relapsed or primary-refractory Hodgkin lymphoma. 5. The function of major organs is normal, and the specific criteria are as follows: bone marrow hematopoietic function is basically normal, blood routine: WBC > = 2.0×10^9/L, ANC = 1.0×10^9/L, PLT > = 50×10^9/L, Hb > = 80 g/L. If the peripheral blood index is abnormal due to lymphoma invasion of bone marrow or spleen, it can be judged by the investigator at the discretion of whether it is suitable for enrollment; Pulmonary function: forced expiratory volume in one second (FEV1) > = 60%, diffusing capacity for carbon monoxide (DLCO) > = 50%; Liver function: total bilirubin, ALT and AST = 60 ml/min (calculated according to the Cockcroft-Gault formula). Male subjects: CLcr = [(140-age (years)× body weight (kg))/[72× serum creatinine (mg/dL)]]; Female subjects: CLcr=0.85× CLcr for male subjects; Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) = 55%, no uncontrolled tachycardia or tachy-bradycardia, normal or abnormal ECG not clinically significant, normal cardiac enzyme spectrum CK-MB, pro-BNP less than 900 pg/ml. 6. Sufficient autologous hematopoietic stem cells have been judged and collected by the investigator: CD34>=2×106/kg; 7. Female not lactating, non-pregnant, female subjects of reproductive potential with a negative serum pregnancy test within 2 weeks prior to enrollment, and agree not to become pregnant during the period of enrollment and for 36 months thereafter; Male or female subjects of reproductive potential must use a highly effective method of contraception throughout the trial and for 1 year after transplantation.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin > 360 mg/m² (1 mg of doxorubicin is equivalent to 2 mg of epirubicin for other anthracyclines). 2. Hypersensitivity to any of the study drugs or their components. 3. Cardiac function and disease consistent with one of the following: a. Long QTc syndrome or QTc interval >480 ms; b. Complete left bundle branch block, second- or third-degree atrioventricular block; c. Severe, uncontrolled cardiac arrhythmias requiring medication; d. New York College of Cardiology grade > = Class III; Cardiac ejection fraction (LVEF) less than 50%; f. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically severe pericardial disease, or ECG evidence of acute ischemic or active conduction abnormalities within 6 months prior to recruitment. 4. Active hepatitis B and hepatitis C infection (positive for hepatitis B virus surface antigen or core antibody and hepatitis B virus DNA more than 1×10³ copies/mL; HCV RNA > 1×10³ copies/mL). 5. Human immunodeficiency virus (HIV) infection (HIV antibody positive). 6. Previous or present concomitant other malignant tumors (except for the following circumstances: malignant tumors that have received treatment with curative intent and have not had known active disease in the > = 5 years prior to enrollment; Basal cell carcinoma of the skin (except melanoma) that has been adequately treated and has no signs of disease; Carcinoma in situ of the cervix that has been adequately treated and has no signs of disease). 7. Have primary or secondary central nervous system (CNS) lymphoma or have a history of CNS lymphoma. 8. Pregnant, lactating females and patients of childbearing age who are unwilling to use contraception. 9. Patients who are unable to collect CD34+ hematopoietic stem cells in quantities greater than or equal to 2×10^6/kg. 10. Patients who have received solid organ transplantation in the past. 11. Those who have undergone secondary surgery or above within three weeks before treatment. 12. Presence of severe active infectious disease requiring systemic antibiotics, antifungal drugs, antiviral therapy within 15 days prior to transplantation. 13. Those who have a history of drug abuse (use of narcotic drugs or psychotropic substances for non-medical purposes) or drug dependence (sedative-hypnotics, analgesics, narcotics, stimulants and psychotic drugs, etc.). 14. Has a history of severe neurological or psychiatric illness, including dementia or epilepsy. 15. History of psychiatric illness or cognitive impairment. 16. Patients who, in the opinion of the investigator, are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of pretreatment-related adverse reactions and transplant-related mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematopoietic reconstruction criteria;Efficacy evaluation and follow-up; | — |
Countries
China
Contacts
Public ContactGuifang Ouyang
The First Affiliated Hospital of Ningbo University
Outcome results
None listed