Acute leukemia with a history of extramedullary disease
Conditions
Interventions
Experimental group:Mitoxantrone liposome 30mg/m^2 on day -11
Total body irradiation (TBI) 9Gy over 3 days
Cyclophosphamide (CTX) 3.6g/m^2 over 2 days
Cytarabine (ARA-C) 4g/m^2 over 2 days.
Control group:Total body irradiation (TBI) 9Gy over 3 days
Cyclophosphamide (CTX) 3.6 g/m^2 over 2 days
Sponsors
The 960th Hospital of the Joint Logistic Support Force of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for acute leukemia and have a history of extramedullary disease; 2. Patients without a fully matched sibling donor and who are candidates for haploidentical hematopoietic stem cell transplantation; 3. ECOG score of 0-2; 4. Organ function levels 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; b) Kidney: Serum creatinine = 1.5×ULN; c) Coagulation function: International normalized ratio (INR) and Activated partial thromboplastin time (APTT) = 1.5 × ULN; d) Normal cardiac function: That is, normal or clinically insignificant ECG abnormalities, Left ventricular ejection fraction (LVEF) greater than 60 or normal myocardial enzyme profile CK-MB, pro-BNP below 900 pg/ml; 5. Female subjects of reproductive potential must have a negative serum pregnancy test result before the first administration of the trial medication.
Exclusion criteria
Exclusion criteria: 1. Have previously received doxorubicin or other anthracycline drugs, with a total cumulative dose of doxorubicin exceeding 360 mg/m^2; 2. Are allergic to any of the study drugs or their components; 3. Cardiac function and disease meet one of the following conditions: (1) Long QTc syndrome or QTc interval >480 ms; (2) Complete left bundle branch block, second or third-degree atrioventricular block; (3) Severe and uncontrolled arrhythmias requiring drug treatment; (4) New York Heart Association classification = class III; (5) Left ventricular ejection fraction (LVEF) below 50%; (6) History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any arrhythmias requiring treatment, clinical history of severe pericardial disease, or evidence of acute ischemia or active electrocardiogram system abnormalities. 4. Active infection with Hepatitis B and Hepatitis C; 5. Infection with the Human Immunodeficiency Virus (HIV); 6. Patients with other malignant tumors; 7. Pregnant and lactating women who are unwilling to take contraceptive measures, as well as patients of childbearing age; 8. History of drug abuse; 9. History of mental illness or cognitive disorders; 10. Other conditions that researchers judge as unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions to the conditioning reginem;Incidence of acute graft-versus-host disease;Overall survival;Progression-free survival ;Incidence of Cytomegalovirus and Epstein-Barr Virus Infections; | — |
Countries
China
Contacts
Public ContactFang Zhou
The 960th Hospital of the Joint Logistic Support Force of the People's Liberation Army of China
Outcome results
None listed