Myelodysplastic Syndrome (MDS) Patients with Intermediate High, High, and Very High Risk According to the IPSS-M Scoring System
Conditions
Interventions
Pretransplant cytoreductive therapy:Pretransplant cytoreductive therapy
Upfront transplantation:Upfront transplantation
Sponsors
Shanghai Zhaxin integrated traditional Chinese and Western Medicine Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Newly diagnosed with myelodysplastic syndromes (MDS) before enrollment, with diagnostic criteria referring to the 2022 WHO classification. 2.Previouly untreated for MDS, including chemotherapy, demethylating agents, or hematopoietic stem cell transplantation. 3.IPSS-M score of intermediate-high risk or higher. 4.Ages between 14 and 75 years old. 5.Suitable for hematopoietic stem cell transplantation (HSCT) with at least one qualified donor. 6.Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0- 2. 7.Appropriate organ function is required for trial treatment, with laboratory test results within 7 days prior to the start of treatment meeting the following criteria: - Aspartate Aminotransferase (AST) = 3 times the Upper Limit of Normal (ULN) ; - Alanine Aminotransferase (ALT) = 3 times ULN ; - Total serum bilirubin = 1.5 times the ULN, unless the patient has a documented history of Gilbert's syndrome; for Gilbert-Meulengracht syndrome patients with bilirubin = 3.0 times the ULN and direct bilirubin = 1.5 times the ULN, they can be included ; - Serum creatinine = 1.5 times ULN, or creatinine clearance = 60 mL/min ; - Coagulation function: International Normalized Ratio (INR) = 1.5 times ULN, Activated Partial Thromboplastin Time (APTT) = 1.5 times ULN . 8.Expected survival of at least 12 weeks. 9.Voluntarily sign an informed consent form and are capable of understanding and adhering to all study requirements.
Exclusion criteria
Exclusion criteria: 1.Progression to Acute Myeloid Leukemia (AML) before diagnosis or during pre-transplant treatment; 2.Active autoimmune diseases; 3.Active cardiovascular disease. 4.Other severe conditions that may limit a patient's participation in this trial (such as advanced infections, uncontrolled diabetes). 5.HIV infection, or uncontrolled chronic Hepatitis B virus or Hepatitis C virusinfections; 6.Concurrent other malignancies that have not been cured. 7.Neurological or psychiatric disorders. 8.Pregnant or breastfeeding women. 9.Patients who cannot understand, comply with the study protocol, or are unable to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year-PFS; | — |
Countries
China
Contacts
Public ContactWang chun
Shanghai Zhaxin integrated traditional Chinese and Western Medicine Hospital
Outcome results
None listed