Actively Recruiting
Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-11-26
40
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
By collecting interventional clinical data to assess the survival and relapse conditions of patients post-transplantation and comparing them with historical data, the primary study endpoint is the 1-year and 2-year relapse-free survival (RFS) post-transplantation. This includes the time from the start of treatment until the documentation of disease progression (bone marrow smear blast cells \> 5% or extramedullary relapse) or death due to any cause, whichever occurs first. This experiment aims to improve the post-transplant survival rates of MDS patients classified as very high risk under the IPSS-M stratification and to explore pathways to prevent relapse.
CONDITIONS
Official Title
Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, male or female
- Diagnosed with myelodysplastic syndromes (MDS) classified as very high risk by IPSS-M
- Suitable hematopoietic stem cell donor: related donors must be at least 5/10 matched; unrelated donors at least 8/10 matched for specified HLA markers
- Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score of 2 or less
- ECOG performance status of 0 to 2
- Adequate organ functions: serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Cardiac ejection fraction ≥ 50%
- Baseline oxygen saturation greater than 92%
- Total bilirubin ≤ 1.5 times ULN
- ALT and AST levels ≤ 2.0 times ULN
- Pulmonary function: DLCO corrected for hemoglobin ≥ 40% and FEV1 ≥ 50%
- Ability to understand and willingness to participate with signed informed consent
You will not qualify if you...
- Failure to proceed with stem cell reinfusion after unsuccessful pre-transplant conditioning
- History of previous hematopoietic stem cell transplantation (HSCT)
- ECOG performance status greater than 2
- Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score of 3 or higher
- Unstable systemic diseases including recent (within 3 months) unstable angina, stroke, or myocardial infarction
- Congestive heart failure NYHA class III or higher
- Post-pacemaker implantation requiring medication for severe arrhythmias
- Severe liver, kidney, or metabolic diseases
- Pulmonary arterial hypertension
- Active uncontrolled infection or signs of worsening infection
- Need for treatment for grade 2 or higher epilepsy
- Neurological conditions such as paralysis, aphasia, new cerebral infarction, severe brain trauma, dementia, Parkinson's disease, schizophrenia
- HIV infection
- Active hepatitis B or C requiring antiviral treatment
- Risk of hepatitis B reactivation without antiviral therapy
- Pregnant or breastfeeding women
- Men and women of childbearing potential unwilling to use contraception during treatment and for 12 months after
- Allergic to azacitidine, decitabine, or venetoclax
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China, 200080
Actively Recruiting
Research Team
X
Xianmin Song, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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