Myeloid neoplasms
Conditions
Interventions
Therapy group:underwent transplantation with a reduced-intensity conditioning regimen combining decitabine and FluMel
Sponsors
The 923rd Hospital of the Joint Logistics Support Force of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be eligible for enrollment: 1.The participant's age at the time of signing the informed consent form is between 60 and 75 years old. 2.The participant must understand and voluntarily agree to participate in this study by signing the informed consent form. 3.The participant must have a documented diagnosis of a myeloid neoplasm such as Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), or Myeloproliferative Neoplasm (MPN), have an indication for allogeneic hematopoietic stem cell transplantation (allo-HSCT), and have a suitable donor available. 4.The patient's disease status is stable, with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, and is able to tolerate transplantation-related procedures and the conditioning regimen. 5.Adequate organ function levels: ? Left ventricular ejection fraction (LVEF) = 40% as indicated by echocardiography, without severe heart failure (NYHA Class = II), recent myocardial infarction, or severe arrhythmia. ? Lung function tests are essentially normal. ? Serum total bilirubin 60 mL/min, and serum creatinine = 1.5 × ULN.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study: 1.Uncontrolled active infection (e.g., sepsis, fungal infection). 2.Pregnancy, lactation, or participants of childbearing potential unwilling to use effective contraception. 3.Concurrent cardiopulmonary insufficiency, such as mild-to-moderate pulmonary ventilation dysfunction or cardiac function > Class III (e.g., NYHA classification > III). 4.Concurrent severe hepatic or renal impairment:Hepatic insufficiency (total bilirubin > 1.5 × ULN, ALT or AST > 3 × ULN);Renal insufficiency (estimated glomerular filtration rate, eGFR = 60 mL/min). 5.Severe infectious diseases, such as active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. 6.History of other invasive malignancies within the past 5 years (except for low-risk tumors such as non-melanoma skin cancer or carcinoma in situ of the cervix). 7.Psychiatric/cognitive impairment preventing compliance with treatment or follow-up, or presence of severe mental illness. 8.Concurrent participation in another investigational drug study or treatment with any other investigational agent. 9.Prior allogeneic hematopoietic stem cell transplantation or gene therapy. 10.Any other concurrent disease, condition, or reason that, in the opinion of the investigator, could interfere with the study procedures. 11.Considered by the investigator to be unsuitable for participation in this study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-relapse mortality at 1-year post-transplantation;1-Year Overall Survival Rate Post-Transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-Year Disease-Free Survival Rate Post-Transplantation;1 1-Year Cumulative Incidence of Relapse Post-Transplantation;Incidence of Grade II-IV Acute Graft-versus-Host Disease within 100 Days Post-Transplantation;Incidence of Chronic Graft-versus-Host Disease within 1 Year Post-Transplantation;Incidence of Adverse Events; | — |
Countries
China
Contacts
Public ContactYin Xiaolin; Zhou Yali
The 923rd Hospital of the Joint Logistics Support Force of the People's Liberation Army
Outcome results
None listed