A Clinical Study on the Combination of Mitoxantrone Liposome Injection, Bendamustine, Etoposide, and Cytarabine for Pretreatment of Autologous Hematopoietic Stem Cell Transplantation in Patients with Lymphoma

Inclusion Criteria:

* 1\. The patients voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up; 2. Patients with histologically or pathologically confirmed non-Hodgkin lymphoma or malignant lymphoma, regardless of gender, 18 to 75 years of age (including the upper limit), are scheduled to undergo autologous hematopoietic stem cell transplantation; 3. Physical status of the Eastern Cancer Collaboration Group (ECOG) : the score was 0\~2, and the expected survival time was more than 3 months; 4. Patients judged by researchers to be suitable for stem cell transplantation:

  1. Consolidation therapy after first-line induction chemotherapy for aggressive non-Hodgkin lymphoma with poor prognostic factors;
  2. It is suitable for salvage treatment of chemotherapy-sensitive non-Hodgkin lymphoma after recurrence;
  3. and salvage treatment of relapsed or primary refractory Hodgkin lymphoma that is sensitive to chemotherapy.

  5\. The main organs function normally, the specific criteria are as follows:
  1. 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 indexes were abnormal due to lymphoma invading bone marrow or spleen, the researchers could determine whether the patients were suitable for inclusion.
  2. Lung function: forced expiratory volume in one second (FEV1) ≥60%, carbon monoxide dispersion (DLCO) ≥50%;
  3. Liver function: total bilirubin, ALT and AST \<2×ULN (upper limit of normal); AST and ALT≤3 times the upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5×ULN (if there is liver invasion, AST and ALT≤5×ULN are allowed);
  4. Renal function: serum creatinine ≤1.5×ULN, creatinine clearance (CrCl) ≥ 60 ml/min (calculated according to Cockcroft-Gault formula). Male subjects: CLcr =\[(140- age (years) x body weight (kg)) /\[72 x serum creatinine (mg/dL)\]; Female subjects: CLcr=0.85× CLcr of male subjects;
  5. Coagulation function: International standardized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN;
  6. Normal cardiac function: echocardiography or nuclide cardiac function test showed LVEF ≥ 55%, no uncontrolled tachycardia or Tachycardia syndrome, normal or abnormal ECG examination had no clinical significance, myocardial enzyme spectrum CK-MB was normal, pro-BNP was less than 900 pg/ml.

  6\. Sufficient autologous hematopoietic stem cells have been assessed and collected by researchers: CD34≥2×106/Kg; 7. The women were not lactating, were not pregnant, and the female subjects with reproductive capacity were tested for serum pregnancy within 2 weeks before enrollment Test negative and agree not to become pregnant during the study period and for 36 months thereafter; Fertile male or female subjects must use a highly effective contraceptive method throughout the trial and for 1 year after the transplant.

Exclusion Criteria:

* 1\. Received doxorubicin or anthracycline treatment in the past, and the total cumulative dose of doxorubicin was \> 360 mg/m² (1 mg doxorubicin is equivalent to 2 mg epirubicin for other anthracycline drugs).

  2\. Hypersensitivity to any investigational drug or its ingredients. 3. Cardiac function and disease consistent with 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 50%; 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.

  4\. Hepatitis B, hepatitis C active infection (hepatitis B virus surface antigen or core antibody positive and hepatitis B virus DNA ultra Over 1×10³ copy /mL; More than 1×10³ copies /mL of HCV RNA). 5. Human immunodeficiency virus (HIV) infection (HIV antibody positive). 6. Previous or current co-occurrence of other malignancies (with the exception of malignancies with no known active disease occurring for ≥5 years prior to enrollment that have been treated for the purpose of cure); Basal cell carcinoma of the skin that has been adequately treated and shows no signs of disease (except melanoma); Well-treated carcinoma in situ of the cervix with no signs of disease).

  7\. Have primary or secondary central nervous system (CNS) lymphoma or have a history of CNS lymphoma.

  8\. Pregnant and lactating women and patients of childbearing age who do not want to take contraceptive measures.

  9\. Patients who cannot collect CD34 + hematopoietic stem cells in quantities greater than or equal to 2×10\^6/kg.

  10\. Patients who have previously received solid organ transplants. 11. Patients who have received secondary or higher surgery within three weeks prior to treatment.

  12\. Serious and active infectious diseases requiring systemic antibiotics, antifungal drugs, and antiviral treatment were present within 15 days prior to transplantation.

  13\. People with a history of drug abuse (non-medical use of narcotic drugs or psychotropic drugs) or dependence on drugs (sedatives, hypnotics, analgesics, narcotics, stimulants and psychotropic drugs, etc.).

  14\. Have a history of severe neurological or mental illness, including dementia or epilepsy.

  15\. History of mental illness or cognitive impairment. 16. Patients deemed unsuitable for enrollment by the investigator.