Myelodysplastic Syndrome with fibrosis
Conditions
Interventions
Trial group:Decitabine (20 mg/m 2/d, ivgtt, -9 to -7 days)
Thiotepa,(5mg/kg. d ivgtt, -8 days)
Busulfan((Bu, 0.6mg/kg. Continuous ivgtt, Q6h, -7 to -5 days)
Fludarabine (Flu 30 mg/m2/d, ivgtt, -7 to -
Sponsors
The First Affiliated Hospital of Zhejiang University, School of Medicine,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18–65 years, regardless of gender or race; 2. Confirmed diagnosis of myelodysplastic syndrome according to the WHO 2022 criteria, with fibrosis grade 2 or higher (based on the 2005 European fibrosis grading system); 3. Planned to undergo allogeneic hematopoietic stem cell transplantation and must have a suitable hematopoietic stem cell donor; 4. Hematopoietic cell transplantation-specific comorbidity index (HCT-CI) = 50%; (3) Baseline oxygen saturation > 92%; (4) Total bilirubin = 40% and FEV1 >= 50%; 7. Patients must be able to understand and willingly participate in this study and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. History of any malignancy other than MDS within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally cured prostate cancer after radical surgery, or ductal carcinoma in situ after radical surgery; 2. ECOG performance status > 2; 3. Hematopoietic cell transplantation-specific comorbidity index (HCT-CI) >= 3; 4. Any unstable systemic disease, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack (within 3 months prior to screening), myocardial infarction (within 3 months prior to screening), congestive heart failure (NYHA classification >= III), pacemaker implantation with need for pharmacologic management of serious arrhythmias, or liver, kidney, or metabolic disorders; patients with pulmonary hypertension; 5. Active uncontrolled infection: characterized by infection-related hemodynamic instability, worsening of new infection signs or symptoms, newly identified infectious lesions on imaging, or persistent fever without clear etiology that cannot exclude infection; 6. Need for treatment of grade >=2 epilepsy, paralysis, aphasia, new cerebral infarction, severe traumatic brain injury, dementia, Parkinson’s disease, or schizophrenia; 7. Human immunodeficiency virus (HIV) infection; 8. Patients with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) requiring antiviral therapy; patients at risk of HBV reactivation, defined as those who are hepatitis B surface antigen-positive or hepatitis B core antibody-positive but have not received anti-HBV therapy; 9. History of autoimmune disease; 10. Pregnant or lactating females; 11. Sexually active males and females of childbearing potential who are unwilling to use contraceptive methods during treatment and for 12 months after treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet engraftment rate 30 days after transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Neutrophil Engraftment Rate at 30 Days Post-Transplantation;2-Year Non-Relapse Mortality (NRM) Post-Transplantation;2-Year Overall Survival (OS) and Disease-Free Survival (DFS);2-Year Cumulative Incidence of Relapse;Incidence of Acute Graft-versus-Host Disease (GVHD) within 100 Days Post-Transplantation;2-Year Cumulative Incidence of Chronic GVHD;GVHD-free, Relapse-free Survival (GRFS); | — |
Countries
China
Contacts
Public ContactTong Hongyan
The First Affiliated Hospital of Zhejiang University, School of Medicine,
Outcome results
None listed