Myelodysplastic Syndromes
Conditions
Interventions
Experimental group:Ultra-Low-Dose Decitabine Combined with Escalating-Dose Donor Lymphocyte Infusion
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age and informed consent: age 18-70 years old (inclusive), and voluntarily sign written informed consent; 2. Myelodysplastic syndrome (MDS) confirmed by World Health Organization (WHO) standards, confirmed by gene mutations: the presence of TP53 biallelic mutation (Bi-TP53 mutation) confirmed by next-generation sequencing (NGS) technology (defined as: two or more TP53 mutations detected in the same cell clone, or one TP53 mutation plus TP53 copy number loss or copy neutral heterozygosity loss, or TP53 mutation VAF value >50%.). 3. Planned to receive or have received the first allogeneic hematopoietic stem cell transplantation (allo-HSCT); 4. Related or unrelated donors with human leukocyte antigen (HLA) homozygous (8/8 or 10/10) or haploidentical; 5. Received myeloablative conditioning (MAC) or reduced intensity conditioning (RIC); 6. Adequate organ function (assessed before starting study intervention): Cardiac: left ventricular ejection fraction (LVEF) >= 50%. Liver: Total bilirubin = 50 mL/min (Cockcroft-Gault formula); 7. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status score <= 2; 8. Female and male patients of childbearing age must agree to use effective contraception during the study and for 6 months after the end of treatment. Female patients must have a negative pregnancy test prior to starting treatment.
Exclusion criteria
Exclusion criteria: 1. Malignant tumors other than MDS within 5 years prior to screening; except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, locally treated prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery; 2. ECOG > 2; 3. 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 (New York Heart Association [NYHA] class >= III), severe arrhythmias requiring drug treatment after pacemaker implantation, liver, kidney, or metabolic diseases; patients with pulmonary hypertension; 5. Active uncontrolled infection: hemodynamic instability related to infection, or new or worsening infection symptoms or signs, or imaging showing new infectious lesions, or persistent fever without symptoms or signs where infection cannot be excluded; 6. Seizures >= Grade 2 requiring treatment, paralysis, aphasia, newly developed cerebral infarction, severe traumatic brain injury, dementia, Parkinson’s disease, schizophrenia; 7. At the start of the planned intervention study (30 to 45 days post-transplant), patients with grade III-IV acute graft-versus-host disease (aGVHD) or extensive chronic GVHD (cGVHD) requiring systemic therapy. Patients with severe post-transplant complications, such as severe VOD/SOS, TMA, or post-transplant lymphoproliferative disorder (PTLD); 8. Individuals infected with human immunodeficiency virus (HIV); 9. Patients with active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy; patients at risk of HBV reactivation, referring to those who are HBsAg positive or anti-HBc positive without receiving anti-HBV treatment; 10. History of autoimmune diseases; 11. Pregnant or breastfeeding women; 12. Fertile men and women who are unwilling to use contraception during treatment and for 12 months after treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month Relapse-Free Survival (RFS) rate post-transplant; | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-Relapse Mortality (NRM);Cumulative Incidence of Relapse (CIR);Incidence of Grade II-IV acute Graft-versus-Host Disease (aGVHD);6-month Overall Survival (OS) rate; | — |
Countries
China
Contacts
Public ContactTong Hongyan
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed